The document provides an overview of SNC-Lavalin Pharma's expertise in the biopharmaceutical industry. It discusses their services, technical expertise, knowledge of applicable standards and regulations, systems life cycle approach, and knowledge of special systems and elements relevant to the industry such as layout planning, process and automation, water systems, environment systems, dust control, effluent treatment, room finishes, and safety issues. SNC-Lavalin Pharma has over 20 years of experience providing engineering services for biotech and pharmaceutical clients.

2. Table of contents
Chapter 1
CORPORATE OVERVIEW
Chapter 2
TECHNICAL EXPERTISE
Chapter 3
DESIGN – PERTINENT EXPERIENCE
Chapter 4
VALIDATION - PERTINENT EXPERIENCE
Chapter 5
AUTOMATION AND INTEGRATION – PERTINENT EXPERIENCE
Chapter 6
PROCESS ENGINEERING – PERTINENT EXPERIENCE
Chapter 7
PROJECT FACT SHEETS

3. 1. CORPORATE OVERVIEW
SNC-Lavalin Pharma (SLP) is a leading global engineering, procurement,
construction, validation, compliance and related technical services organization
serving the biotechnology and pharmaceutical industries, life sciences
organizations and the institutional sector. SNC-Lavalin Pharma has a global
responsibility for the Bio-Pharmaceutical sector within SNC-Lavalin Inc.
SNC-Lavalin Inc. (SLI) is one of the world’s largest groups of engineering and
construction companies as well as a major player in the ownership of
infrastructure and operating & maintenance services. With offices in 34
countries, SLI is currently working on projects in over 100 countries around the
world. As one of SNC-Lavalin’s divisions, SNC-Lavalin Pharma is part of an
integrated worldwide network of 18,000 highly qualified employees.
SNC-Lavalin Pharma offers services that meet the needs of the
biopharmaceutical industry, which include the design, implementation and
validation of projects involving research, manufacturing and support facilities.
We offer these services from offices in Philadelphia, Montréal, Quebec, Toronto,
Calgary, Brussels, Lyon and Mumbai, which represent an international network
of over 700 specialists. These specialists have a solid base in engineering,
validation and project execution and are capable of developing novel and creative
leading edge solutions based on industry needs. These professionals are
specialized in servicing the pharmaceutical and bio-technological companies and
can provide the full spectrum of services from preliminary studies to process
validation.
SNC-Lavalin Pharma has assembled a highly qualified and experienced group of
resources represented in areas of major pharmaceutical and biotechnological
activities. Growth has come from both organic growth and from partnering
activities integrated into one industry-focused group. Using a flexible
organization approach and virtual office systems, specialized resources from
around the globe can be brought to bear to a project in any region. SLP is made
up of the following members:
• LKM Engineers, Toronto and Sudbury, ON
• Pellemon, Montréal, QC
• Wiebe Forest Engineering, AB
• Sogequip, Lyon, France
• Coppée-Courtoy, Brussels, Belgium
• Pipecon Consultants Pvt., Mumbai

4. With the expertise of our qualified staff, many of whom have industry
experience, we can tailor our services to ensure the satisfaction of our clients. In
this context, and with the experience of our centres of excellence, we are well
equipped to offer the following individual or integrated services:
• Process Architecture
• Facility Engineering
• Process Engineering
• Process Automation
• Design Visualization
• Robotics
• Validation & Compliance
• Project Management
• Procurement
• Construction Management
All SLP offices are linked through sophisticated information technologies,
allowing a seamless transfer of documents and information. This ensures that the
Project Team will have easy access to all required information wherever they are
located.

5. 1.1 SNC-LAVALIN PHARMA AND THE BIO-PHARMACEUTICAL INDUSTRY
SNC-Lavalin Pharma’s desire to be involved in biotech and pharmaceutical
projects has its source in the fact that SNC-Lavalin Pharma’s engineers recognize
that the needs of the pharmaceutical industry’s engineering systems are among
the most challenging in terms of sophistication and complexity.
In order to maintain a leading edge in high tech building and process
technologies, SNC-Lavalin Pharma recognizes its own need to invest in R&D in
this field, as is the case for the pharmaceutical industry in its own fields of
expertise. As a consequence, SNC-Lavalin Pharma is following in the footsteps
of the pharmaceutical industry and has started what it considers to be a very
innovative building technology R&D plan that revolves around two major poles:
− SNC-Lavalin Pharma’s role as founding partner in the Central Canada
Chapter of the ISPE (International Society for Pharmaceutical
Engineering).
− SNC-Lavalin Pharma’s role as founding partner in the Canadian Chapter
of A3P (Association for Clean and Sterile Products, based in Europe).
− SNC-Lavalin Pharma’s role as an affiliate member of IRPI (Institute for
Research in Industrial Pharmacy).
− Active participation of our staff in industry forums, technology-related
panels and similar functions in life sciences sectors.
Through a very proactive presence in these organizations, SNC-Lavalin Pharma
is significantly investing in terms of time, energy and financial resources and
recoups solid technical training and a better global understanding of the
pharmaceutical industry’s design and compliance needs and requirements.
As the pharmaceutical industry has clearly demonstrated in the past with its
massive investment in R&D, SNC-Lavalin Pharma strongly feels that its future
success and survival directly depend on these R&D efforts, in addition to
creating strategic alliances with the pharmaceutical industry.

6. 2. TECHNICAL EXPERTISE
For twenty years, SNC-Lavalin Pharma has carried out numerous projects for
biotechnological and pharmaceutical industries as well as for hospitals and
government agencies. These include R&D laboratories,
manufacturing/production areas, in particular pertaining to solid dosage
(granulation and compression), coating columns, fluid bed dryers, production of
antibodies, solvent tank farms, liquid production lines, etc.
SNC-Lavalin Pharma has thus developed a dedicated team of specialists with
current expertise in the process design, facility engineering and validation of the
sophisticated systems usually required in such facilities.
These requirements reflect the industry’s needs to create, control and monitor,
among others, the environmental parameters (temperature, humidity, pressure,
ventilation, filtration) while ensuring the safety of researchers, operators and
other workers as well as adequately confining associated chemical and biological
contamination risks.
Our frequent and close collaboration with the engineering departments of our
pharmaceutical and biotech clients has given SNC-Lavalin Pharma the
opportunity to acquire a thorough understanding of the specific and challenging
needs of research as well as production, in addition to the requirements of the
authorities having jurisdiction (FDA cGMPs, TPP cGMPs and GLPs, Sanitary
3A, CSA, NFPA and FM/ULC).
This understanding has also included a very close collaboration, on a number of
our mandates, with inspectors from the American FDA, the British MCA as well
as from the Therapeutic Products Programme (TPP) of Health and Welfare
Canada, for the validation of facilities, systems and equipment.

7. 2.1 KNOWLEDGE OF APPLICABLE STANDARDS AND REGULATIONS
SNC-Lavalin Pharma’s expertise more particularly cover the standards usually
applied to the design of pharmaceutical production and research centers and
laboratories, including sterile facilities and injectable handling systems, which
must be certified by the FDA and the TPP, as well as meeting the current good
manufacturing practices standards (cGMPs) published by the Code of Federal
Regulations (Chapter 21) for the United States and by Health and Welfare
Canada. The interpretation of these GMPs, which are regularly published in the
Code of Federal Regulations, is also of interest, as the standards are constantly
updated in order to meet new industry requirements. The rapid evolution of the
good laboratory practices (GLPs) applicable to research facilities’ activities is
also very closely followed by SNC-Lavalin Pharma.
The members of SNC-Lavalin Pharma’s pharmaceutical and research facilities
project teams are all well aware of the importance of proper interpretation of
these standards and of their constant evolution due to the changing needs of the
industry, but also to the availability of new technical solutions. This is why a
constant effort is made by SNC-Lavalin Pharma to improve its level of awareness
in this field; this is done by means which include technological transfers and
training, including attending educational seminars set up by ISPE North America
and European branches, as well as direct consultations with US-based experts
specialized in the validation and certification of pharmaceutical systems.
Regulations regarding the confinement of biological hazards are also of utmost
importance as they define several basic criteria to be met by electromechanical
systems and important architectural elements of buildings where products with
potentially high risks of biological contamination are handled. Policies
concerning bio-safety in laboratories, as published by the Center for Biological
Diseases of the US Department of Health and Human Services and the
Laboratory Center for Disease Control of Health and Welfare Canada, strictly
govern this matter. Similarly, the regulation published by the Atomic Energy
Control Board (document R-52) states their guidelines concerning the handling
of elementary and intermediate radioisotopes in a laboratory.
Our process automation personnel is bound by our internal procedures (our
quality manual is available for on-site review) and these reflect, where relevant,
ANSI/ISA-S88.01 and GAMP standards.
As for animal facilities, the standards and requirements stipulated by the
Canadian Council on Animal Protection (Manuals on Care and Use of Animals
for Experimentation, volumes 1 and 2) serve as reference.

8. 2.2 THE SYSTEM LIFE CYCLE APPROACH
The System Life Cycle approach was developed by the biopharmaceutical
industry in recent years. At SNC-Lavalin Pharma, we have developed our own
version of the System Life Cycle (SLC) approach in the last few years and we
continue to adapt it in order to better serve our biopharmaceutical clients.
The System Life Cycle breaks down the project into three majors phases, made
up of a total of nine steps, which are common to all projects. The SLC involves
not only the A/E firm but all the stakeholders for the project. In fact, even if
SNC-Lavalin Pharma is not directly involved in all the steps of the SLC, we try
to give the best input possible to our Client to ensure a smooth transition from
one phase to the other.
The scheduling phase is split into three steps: an opportunity study, a feasibility
study and a study of variables. It is during the scheduling phase that the major
issues need to be discussed and resolved. Any major issues that are missed in
this phase could have a significant impact on the financial or technical viability
of the project.
The realization phase is split into four steps: basis of design, detailed design,
procurement and construction. Obviously, this is where SNC-Lavalin Pharma
has the biggest impact on the project and where we would put a lot of effort into
guaranteeing the best A/E and CM services to our Client.
The operation phase is split into two steps: installation and operation. It is in this
phase that some of the most critical steps of the validation are completed. The
last step, operation, normally has no end point and is managed by our Client on a
continuous basis.

9. 2.3 KNOWLEDGE OF SPECIAL SYSTEMS AND ELEMENTS
SNC-Lavalin Pharma’s specialized expertise results in extensive familiarity with
the standards and best practices used in the pharmaceutical industry for the
following areas:
Layout planning
Special planning of corridors, loading and unloading docks, production, storage
and packaging rooms and of their location, as well as the careful planning of
doors and room access allows for the optimal use of areas for handling and
circulation of raw material, semi-finished, finished and packaging materials,
equipment and personnel, animal circulation (clean-dirty corridors concept)
while meeting production needs and avoiding cross-contamination. Research
facility characteristics also include a high level of M/E content thus creating a
significant need for M/E equipment room areas, a higher floor-to-floor height, a
lower building net to gross area ratio, and a need to coordinate locations of M/E
rooms so as to limit the possibilities of effluent reingestion.
Process and Automation
When it comes to production skids, the scope of services for the design of
process and automation engineering includes process flow diagrams (PFDs),
piping and instrumentation drawings (P&IDs), general arrangement drawings
(GAs), process equipment specifications (bid package, bid analysis and
recommendations) and automation specifications (instruments, instrumentation
and mechanical equipment index, control loop diagrams, layout drawings,
installation details and interconnection drawings).
Process and automation expertise in the pharmaceutical industry covers process
skids, process utilities, environmental systems, and clean-in-place (CIP) systems.
Process skids include solvent tank farms, aqueous and solvent solutions for
coating and granulation, fluid bed dryers, coating columns, liquid production
lines, packaging and filling lines, etc.
Process utilities include USP purified water, compressed air, nitrogen blanketing,
process steam, clean steam, process air conditioning, hot and cold water, etc.
Environmental systems include spill containment and waste solvent collection
measures, measures against solvent vapour emissions, decontamination systems,
etc.
Clean-in-place (CIP) systems include production, storage, distribution and
recovery (and recycling) of cleaning solutions, from simple systems such as
wash-in-place (WIP) to clean-in-place (CIP) and finally, sterilize- or steam-in-
place (SIP).

10. The integration of liquid process services with process skids in the fixed furniture
is also a key element for flexibility.
Water systems
Recognizing the acute need of the industry on this matter, SNC-Lavalin Pharma
has acquired solid expertise in the design, construction and validation of water
treatment systems and water distribution networks producing water-for-injection
(WFI), USP purified water, and laboratory quality demineralized water, using a
combination of multi-layer filtration, water softening, 5 micron filtration,
chlorine removal, distillation or reverse osmosis process, deionization (mixed bed
or continuous), U/V sterilization and final filtration to achieve both the chemical
and the bacteriological water quality required by the client. The right selection of
piping material, welding methods, network cleaning, jointing and erection
methods, temperature conditions, minimum flow rates and velocity to be
maintained for these networks are all parameters that must be controlled to
achieve acceptable results.
Environment systems
Ventilation and air conditioning systems are designed to create a clean and/or
aseptic environment, free of contamination, to meet the requirements of the
industry and the applicable norms. Air filtration levels and the creation of clean
rooms of classifications ranging from 100,000 to 100, using HEPA filters, are of
the utmost importance to produce such an environment. In order to maintain the
quality of this environment, the systems must be able to control and monitor the
following parameters: room-to-room relative pressurization levels, air circulation
flow rates, temperature and relative humidity. Essential requirements for
validation and certification of these facilities are that all of the above parameters
be recorded and documented.
Fume hoods and biological safety cabinets, and their arrangement in efficient
systems capable of guaranteeing the scientists’ safety and health while ensuring
an energy-efficient system, is a major issue in a state-of-the-art, energy-efficient
research facility.
Dust control
The control of dust and particle emissions resulting from production processes
requires the installation of dust recovery systems integrated into ventilation and
air conditioning systems. This integration may be required to maintain the
pressure at differential levels even when the dust collector systems are not in
operation. House vacuum systems are also normally required for the periodical
cleaning of equipment and of the rooms themselves.

11. Effluent treatment
Liquid and gaseous effluent treatment systems (such as neutralization,
disinfection and filtration systems and kill tanks (sterilization)) are required by
regulatory authorities (Environment bodies, municipalities) and codes and
standards for the protection of the environment.
Room finishes
The quality of room finishes and the methods and details used for their
construction, ease of maintenance and cleaning, i.e. no holes or cracks may be
visible in the finish, and all surfaces must be sealed. These surfaces must be hard,
smooth and free of sharp edges where dust could accumulate; all protruding
elements in the rooms must be easily cleanable. The impact of these requirements
on the visible elements of electromechanical systems must be considered in their
selection, for proper integration into the overall building.
The high sealing efficiency of the partitions (walls, ceilings, floors) required to
maintain the pressure differential rates needed between adjacent rooms has a
direct impact on the selection of building, structural and architectural systems.
Special sealing systems are sometimes required as a remedy to existing
conditions.
Safety issues
The safety of scientists and other personnel is a very important aspect of the
global design of research centers. Key elements include the following:
• location of means of egress for scientists with respect to the most probable
sources of danger (solvent concentration, fume hoods, etc.);
• location of ventilated solvent storage cabinets;
• fume hoods and biological safety cabinets;
• eye wash and emergency shower water networks and locations;
• solvent storage rooms and explosion venting;
• high solvent content room partitions, explosion rating design and explosion
venting panels;
• sprinkler and fire cabinet locations;
• electrical classification (intrinsically safe systems, explosion-proof areas,
etc.);
• HAZOP (hazardous operations, interlocking, emergency stops, etc.).
Access to electrical and automation systems
Easy access to electrical and automation systems and control elements for
maintenance, calibration and replacement is a key element which must be
considered in design. Explosion-proof rooms, types of ceilings, types of easy

12. cleaning access panels, and their integration into the buildings are all elements
that require particular attention when designing these sophisticated facilities.
Flexibility
This word has a very special significance for pharmaceutical production and
research facilities. With the fast-growing rate at which production and research
can evolve, systems must be designed so that they can still meet the industry
needs in the future.
Communication
Process and building communication networks for voice and data are now
included in state-of-the-art research and manufacturing facilities.
Emergency and UPS
Emergency power supplies for research systems as well as for environmental
systems are now more and more contemplated in research facilities and include
static uninterruptible power supplies (UPS) for process automation.
Building control and monitoring systems for process automation
Recent computer technology combined with industry needs has dramatically
changed the building control integration level in facilities.
SNC-Lavalin Pharma takes pride in the fact that all control and automation
design for all above-listed systems is done in-house by SNC-Lavalin Pharma’s
own team of control and building automation experts.
2.4 CONSTRUCTION MANAGEMENT/GENERAL CONTRACTING
As construction manager, SNC-Lavalin Pharma can become the Owner’s
representative and manage all field construction activities. This includes
responsibility for the construction methods, techniques, sequences, procedures,
costs, schedules, quality and warranty of the construction work. To accomplish
this construction work, SNC-Lavalin Pharma will bid and award contracts to pre-
qualified and approved subcontractors for all segments of the work on a
competitive bid basis.
SNC-Lavalin Pharma is directly accountable to our client for all construction and
other items relating to the construction of the facility. During the construction
phase of the project, we coordinate all activities to develop an orderly, controlled
construction effort within the agreed time frame. Our capability in management,
engineering, budgeting, cost estimating and control, scheduling, purchasing,

13. inspection and labor relations is fully utilized to ensure the successful
achievement of the project objectives.
PM+ ® , SNC-Lavalin’s proven Project Management system, is a professional
delivery service encompassing everything needed to plan, design and construct a
facility with one source directly accountable to the client. The specific benefits
of TPM are:
• Single-source responsibility
• Reduced administrative burden
• Early cost determination and control
• Reduced financial risk
• Schedule compression
Projects are managed by a single individual who has total project responsibility.
This improves coordination and communication from project conception to
completion. The Project Director is ultimately responsible for the delivery of all
aspects of the project, and is the focal point for project information distribution
throughout the assignment. This Director manages all project resources and
facilitates communication between the client and the team of professionals.
PM+ ® allows the design and construction phases to operate as independent
professional organizations; integrated through the Project Director and providing
an optimum balance between design and construction considerations.
Contractual options are tailored to the individual owner’s needs and ensure
delivery within budget, schedule and quality requirements.
SNC-Lavalin Pharma’s ability to meet owner schedule and budget requirements
is enhanced through our project management and reporting systems which
provide our project managers with timely information.
2.5 CONSTRUCTION SUPERVISION, START-UP ASSISTANCE
The engineering construction scope of work includes bid packages
(specifications, standards and drawings), construction management (construction
work, schedule, supervision of process skid installation and shop drawing
approval) and assistance upon start-up operations (training sessions,
documentation required for IQ/OQ validation, automation system debugging and
as-built drawings).
Construction work supervision is of prime importance, ensuring the optimum
quality of facilities. A high level of sophistication of systems and finishes
requires constant follow-up and monitoring, allowing good construction work
progress and quality that meets specification requirements.

14. System start-up, balancing and calibration are essential parts of the project as
they will allow subsequent installation, operation and performance qualifications
(IQs, OQs, PQs) to take place, if required, as well as to gather required
documentation for validation.
SNC-Lavalin Pharma’s team can provide on-site supervision as well as assistance
upon system start-up.
Our recent experience in projects involving production and research centres
shows the importance of the presence of the design team members on-site upon
electrical and automation system start-up in order to be able to assist the various
contractors break in the state-of-the-art systems.
2.6 QUALIFICATION AND VALIDATION
The preparation of documentation proving to regulatory agencies that the facility
conforms to cGMPs is an important issue in the industry.
Every integrated validation process starts with the preparation and
implementation of a validation master plan early on in the design phase; this plan
carefully defines and documents all procedures and activities which have an
impact on the process.
The preparation and early submittal of the validation master plan to authorities
having jurisdiction (TPP and FDA) allows the Owner and the authorities to reach
agreements in principle early in the project. It also allows design deficiencies to
be detected and corrected.
To this end, close collaboration between the Owner’s representatives and SNC-
Lavalin Pharma’s team is required in the elaboration of the validation master
plan, IQs, OQs and PQs as well as Standard Operating Procedures (SOPs), and
their integration as a whole into all other elements which form the overall plant
master file (equipment data sheets, calibration procedures, preventive
maintenance programs, change orders).
SNC-Lavalin Pharma is proud to offer the pharmaceutical industry a complete
range of validation services for building and process systems.

15. 3. PERTINENT EXPERIENCE – DESIGN
Total Cost Year
Genzyme Corporation New Biotech Production Facility, $142 M 2010
Lyon, France
Actavis Suite 3 Project N/A 2008
BD Diagnostics GeneOhm New Medical Device Research and $20 M 2008
Manufacturing Facility
Converted Organics First Biostimulant Production $14.5 M 2008
Facility – CM services
Wyeth Consumer Healthcare Renovation of Laboratories, $8.5 M 2008
Buildings 11 and 14
AstraZeneca Chemistry Labs Expansion, $5 M 2007
Montreal R&D Centre
G+G Partnership Architects New Toronto Centre for $69 M 2007
Phenogenomics (TCP)
GSK Biologicals SF Facility Production Upgrade N/A 2007
GSK Biologicals New Quality Control Laboratory, ∈120 M 2007
Belgium
Guerbet, France Injectable Active Substance Facility ∈5 M 2007
Kasian Architecture University of Calgary – Child $23 M 2007
Development Centre (LEED
Platinum Certifie )
Merial, France Monolayer III Project: Global basic ∈30 M 2007
design & process achievement
engineering
Novasep, France Biotechnology Facility ∈10 M 2007
OPP Forensic Facility CL3 (Containment) Lab Facility $1.1 M 2007
Sandoz Major Expansion - Sterile $40 M 2007
Production Plant
Sanofi Aventis, France New Warehouse ∈10 M 2007
Wyeth Research SmartLab 1 Upgrade, Building 5 $4M 2007
Biovail Steinbach Facility Expansion $27.5 M 2006

16. Total Cost Year
CNRC, Industrial Materials Nanofabrication Clean Room and $3 M 2006
Institute Prototyping Centre Development
Flamel, France Micro-pump Pilot ∈20 M 2006
New Pharma Production Facility
GSK Biologicals Expansion and Retrofit of QC, New $51 M 2006
Shipping fit-out and New Seed
Preparation Areas
GSK Biologicals Expansion of Production Area $50 M 2006
(Option 5) – partial design services
NUCRYST Pharmaceuticals API Production Facility Renovation $2 M 2006
Pdi Pharma GLP & cGMP Facility for $4.8 M 2006
Pharmaceutical Testing (over 15,000
SF of R&D pharmaceutical labs)
Pfizer Consumer Healthcare New Global R&D Laboratory $3.2 M 2006
(relocation)
Roche Diagnostics Inc. Expansion of Existing Offices $6.5 M 2006
Sanofi Aventis, France Logistic Building Restructuring ∈10 M 2006
Sanofi Pasteur New Research Vivarium $18 M 2006
Taro Pharmaceuticals GLP Labs, Validated Production $3.6 M 2006
Facilities Infrastructure and Service
Upgrades
Trent University DNA Cluster Project, including New $20 M 2006
BL3 Laboratory
AstraZeneca OAZis Cafeteria Extension at $1 M 2005
Montreal R&D Centre
Cephalon, France Pharmaceutical Chemical Unit ∈24 M 2005
Charles River Labs Buildings 7 & 8 – Safety $20 M 2005
(previously CTBR) Assessment Lab Complex
Dermik Laboratories Lab and Office Renovation $1.7 M 2005
GSK Biologicals, Belgium Live Viral Vaccine Facility ∈44 M 2005
GSK Biologicals Renovations to Building 15, $13.5 M 2005

17. Total Cost Year
(recipient of Leonardo Award)
Nicholls Yallowega Belanger Northern Ontario School of $17 M 2005
Architects Medicine – Northeast Campus
Pharmacy Faculty and IRIC New Pharmacy Faculty and new $84 M 2005
Research Institute Immunovirology & Cancer Research
Institute
Phyton Biotech Lab and Office Renovation $2.1 M 2005
Therakos Laboratory and Office Renovation $1.6 M 2005
Veterinary Medicine Faculty Veterinary Medical Center and $57 M 2005
– St.Hyacinthe Institute of Veterinary and Food
Biotechnology
Baxter Healthcare Equip Prep Area Sterile Facility $4.7 M 2004
Centocor Cell Banking Facility $4.7 M 2004
DSM Biologics LSE – Large Scale Expansion $140 M 2004
(Design completed, not built)
Lorus Therapeutics Clean Animal (Vivarium) Room $1 M 2004
Facility – FDA Approved
McMaster University DeGroote Centre – Centre for $65 M 2004
Molecular Medicine & Health
Novocol Phase 2 – New Bosch Filling Line $9 M 2004
Pfizer Manufacturing Renovation at Lilitz N/A 2004
Facility
Sanofi Aventis, France Cytotoxic Pilots (2 projects) ∈15 M 2004
AstraZeneca Utilities Upgrade $7 M 2003
Centocor 3000 SF GMP Pilot Plant $3.6 M 2003
Concordia University Loyola Science Faculty $64 M 2003
Hemosol HemolinkTM Commercial Production $57 M 2003
Facility
McGill University Montreal Genomics and Proteomics $20 M 2003
Center

18. Total Cost Year
MDS Nordion Kanata Radiopharmaceutical $30 M 2003
Manufacturing Facility
Merck Frosst Building 9-2 South Fit-out Project $10 M 2003
Merck Frosst Building 10 – North Extension $30 M 2003
Novex Pharma BFS / Compounding Upgrade $10 M 2003
Provincial Government Quebec Public Health Laboratory $10.2 M 2003
including BSL3 Lab
GSK Biologicals, Belgium Production, Filling & Packaging of ∈8.8 M 2002
Human Vaccines
Hema-Quebec New Laboratories for Blood $19 M 2002
Processing Facilities
Novocol Sterilization & Plant Upgrade $2 M 2002
Sandoz Sterile Production Facility $4 M 2002
DSM Biologics ML-31/ML-51 Fit-out $7 M 2001
Merck Frosst Bldg 18 – Office building $35 M 2001
Merck Frosst Bldg 9 – 1st Floor Renovation $16 M 2001
Novocol Ph.1 – Sterilization & Plant Upgrade $2.8 M 2001
Valigen Renovation of 80,000 SF for a New $9 M 2001
Biotech R&D Facility
Charabot, France Raw Material Production Facility ∈11 M 2000
for Perfumes
Johnson & Johnson Plant Expansion Project $19.6 M 2000
Merck Frosst Bldg 19 – PR & D Expansion $45 M 2000
Merck Frosst Bldg 9 – 2nd Floor Renovation $17 M 2000
Merck Frosst Bldg 9 – 2nd Floor Project – $4 M 2000
Research Administration
Merck Frosst Bldg 17 – New Quality Control $12 M 2000
Laboratory Facility
Novartis Interior Renovation Project $2.3 M 2000

19. Total Cost Year
Aeterna Laboratories New Biotech Production Plant $16.5 M 1999
Draximage Lyophilisation Extension $8 M 1999
Galderma Production Cream & Ointments Manufacturing $22 M 1999
and Packaging Facility
Laboratoires 3M Santé, Pharmaceutical Preparation Facility ∈18 M 1999
France for Aerosol Production
Merck Frosst Bldg 10 – Third Floor Fit-out $14 M 1999
Novartis Production Renovation & Additions $10 M 1999
Pfizer West Building $12 M 1999
Roberts Pharmaceuticals Design of New Sterile $10 M 1999
Manufacturing Facility for Liquids
Apotex Renovation of Laboratories $1 M 1998
Merck Frosst Production Area Modernization $83 M 1998
Astra Pharma Rommelag 321 Expansion $2 M 1998
Astra Pharma Liquid Preparation Expansion $0.6 M 1998
National Research Council Biotechnology Research Institute – $20 M 1998
Expansion
Genpharm Process Optimization $1.2 M 1998
Glaxo Wellcome Mepron Malarone Production $4.5 M 1998
Novartis Plant Upgrade $8 M 1998
Pasteur Mérieux Connaught Component Pertussis Program (CP) $13 M 1998
ProMetic Pharma Plant Renovation $5 M 1998
Canadian Red Cross Relocation of Transfusional Services $2.5 M 1997
Center
Connaught Labs BCG Facility $14 M 1997
Genpharm Inc. Process Engineering $1.2 M 1997
Glaxo Wellcome Inc. R&D and Manufacturing Facility $120 M 1997
GSK Biologicals (formerly Flu Vaccine Production Plant $22 M 1997

20. Total Cost Year
Biochem Pharma)
Martec Pharmaceutical Hormone Granulation $6 M 1997
McNeil Pharma HVAC Upgrade for Consumer $0.25 M 1997
Products Plant
Merck Frosst High Shear Mixer Facility $0.3 M 1997
Merck Frosst Building 9 - Small Scale GMP $1.2 M 1997
Facility
Nordion International HVAC Upgrade, Phase I $0.7 M 1997
Novartis Pharmaceutical Modifications to Dorval and Whitby $0.2 M 1997
Corporation Plants
ProMetic Pharma Process Flow Diagrams $0.5 M 1997
Ratiopharm (formerly Upgrade of HVAC Systems $1.2 M 1997
Technilab)
Sanofi Aventis, France SAPHIR Project: Fine Chemical and ∈60 M 1997
Pharmaceutical Units
Schering Evaluation of Purified Water, Pure $0.25 M 1997
Steam and WFI Systems
Astra Pharma Pharmaceutical Research Center $23 M 1996
Bio-Intermediair New Biotech Production and $15 M 1996
Research Center
Bristol-Myers Squibb Warehouse Expansion $2 M 1996
CHUL Biomedical Research Center $22.3 M 1996
MDS Nordion Radiopharmaceutical Wing - HVAC $1 M 1996
System Upgrade
Merck Frosst Prilosec Project $8 M 1996
Merck Frosst Clinical Packaging Area $5 M 1996
Pfizer Renovation of Aseptic Suite $5 M 1996
Pfizer CIP/SIP Process Automation $1 M 1996
Pfizer Dry Blending Unit $1 M 1996

21. Total Cost Year
ProMetic Pharma Sterile Production $0.5 M 1996
Wyeth-Ayerst Renovation of Analytical Chemistry $2 M 1996
Laboratory
Biotechnology Research FDA and HPB Compliance $3 M 1995
Institute
Bristol-Myers Squibb Renovation of Laboratories $10 M 1995
Confab-Biopharm, Algeria FDA Compliance $10 M 1995
Enfant-Jesus Hospital Neurobiology Research Center $10 M 1995
Glaxo New Research Facility, Laboratory, $40 M 1995
P&D, Pilot Plant
Merck Frosst Preparatory Laboratory $4 M 1995
Pharmascience Pilot Plant Renovation $0.5 M 1995
Royal Victoria Hospital New Animal Quarters (vivarium) $3.1 M 1995
UCB Farchim, Switzerland Active Substance Production ∈6 M 1995
Facility for Pharmaceutical Product
Pfizer, France Research Center Extension N/A 1993
Upjohn Pfizer Valdepharm, Pharmaceutical chemical unit ∈32 M 1992
France
Finorga, France Revamping of a chemical ∈20 M 1992
pharmaceutical facility
Janssen Pharmaceutica, Pharmaceutical unit (pill coating) ∈6 M 1990
France
Pfizer, France Organic synthesis facility ∈15 M 1989

22. 4. PERTINENT EXPERIENCE – VALIDATION
Client Project Year
Abbott Provided assistance to the validation department 2002-2003
Montréal, Quebec for various projects:
• Preparation and execution of protocols
for the facilities
• Qualification of utilities for equipment,
including medical gas
• Equipment qualification, including tray
packers
• Pre-project engineering studies
• Review existing validation protocols
and follow-up of Change Control
program.
Andlauer Transportation Validation and Qualification of the Laval 2006-2007
Services (ATS) Inc. Warehouse. Scope of qualification included
Montréal, Quebec empty and loaded temperature mapping of
warehouse.
cGMP Design Review and System Qualification 2004-2005
for designated GMP Distribution Warehouse.
Andlauer Transportation Development of the Corporate Validation 2004
Services (ATS) Inc. Master Plan for GMP and related temperature
Toronto, Ontario controlled distribution services.
Additional compliance services also included:
• cGMP training and Good
Documentation Practices training
• cGMP review of internal distribution
and handling processes
• cGMP review of local SOP’s
AstraZeneca Canada Inc. Ventilator Autoclave System Qualification 2001
Mississauga, Ontario
Validation of the Blow/Fill/Seal Production 1999
Department expansion, including preparation of
the Validation Project Plan; preparation and
execution of protocols for the BFS Filling
Equipment and Finishing Line, On-Line Leak
Detectors, Blister Pack Equipment, Autoclaves,
Facility, Facility Monitoring System;
HVAC,WFI, Medical Gas and Pure Steam
Modifications

23. Client Project Year
Validation of the Expansion of the Liquid
Preparation area, including preparation of the
Validation Project Plan; preparation and
execution of validation protocols for the
Facility, New Tanks, Automation and CIP
systems; HVAC, WFI, Medical Gas and Pure
Steam Modifications; preparation of SOPs for
the CIP system and New Tanks.
Protocol preparation and execution. System 2004
Qualification(s) of 53’ temperature controlled
transportation trailers including IQ/OQ/PQ with
focus on monitoring and control system
controls, empty chamber and loaded chamber
temperature mapping studies.

24. Client Project Year
Aventis Pasteur Ltd. B93 - Qualification of the Formulation, Filling Ongoing
Toronto, Ontario and Freeze Drying Equipment. IQ/OQ/PQ
(Ongoing Long Term Validation activities, Cycle Development &
Partnership since 1997) SOP Preparation for:
• Freeze Dryer
• Filler/Capper/Stopper Machine
• Isolators
Site Part 11 Remediation of Excel spreadsheets
and/or other analytical software for the
integration to a New Data Repository System -
for fifteen (15) systems:
• Creation of User Access Forms for
creating new User Access Groups,
addition of existing users to these User
Access Groups and the modification of
network folder file permissions.
• Create specification documents for
those systems. Including affected areas
such as Data Storage and Retrieval,
Security Design, and Archive
Capabilities.
Site R&D – Part 11 Remediation Services:
• Collect information on the use of
various systems for preparation of User
and Functional Requirement
Specifications.
• Prepare and execute the Qualification
Protocols and prepare final reports.
• Provide user training on the updated
SOPs on changes made through
remediation of the system.
B53 Suite 2 Facility Monitoring System – PQ
Validation activities
Various Buildings (AvP Site) – 8 WFI Control 2003
Panel utility upgrades – IQ/OQ validation
services.
B93 HVAC Cross Contamination Study – Multi
Product Facility requiring dedicated segregation
between facilities.

25. Client Project Year
HVAC PQ / Environmental Monitoring 2002
Qualification.
Autoclave Revalidation IQ, OQ, PQ & Cycle
Development.
Qualification of On line TOC Analyzers.
Compressed Air – On Line Air Drier
Qualification.
Medical Gases – Nitrogen, Oxygen and
Compressed Air – including P&ID
Development, FRS Preparation, IQ, OQ, and
PQ.
Qualification of RSV Purification and 2001
Formulation process equipment, including a
20L, 200L, three 2000L Bioreactors, Harvester,
Media Tanks, Centrifuge, two CIP Skids, 2
HVAC Systems, and Building and Process
Computer Monitoring Systems.
Qualification of several HVAC Systems,
including Environmental Monitoring.
New Research & Development Facility - 2000
preparation of the Validation Master Plan;
preparation and execution of the Validation
protocols and preparation of the applicable PM
and Operational SOPs for various systems and
equipment.
Preparation of the PM and Operational SOPs for
various systems and equipment for the
Component Pertussis Manufacturing Facility.
Preparation of SOPs for the Maintenance
Department for specific maintenance policies
and the PM SOPs for various systems and
equipment.
Validation of the Facility Monitoring System
for the BCG and Hepatitis-A Manufacturing
Facility.
Validation of the Facility Monitoring System
for the Polio Manufacturing Facility.
Research & Development Building – Validation 1999
of the Lyophilizer, HVAC system, Fermenter

26. Client Project Year
and Filler.
Bacterials – HVAC Qualification.
Primary Production Measles – HVAC/ Duct 1999
Blowers Qualification.
Sterility Test – HVAC Validation.
Cleaning Validation for various departments, 1998
data analysis and preparation of final reports.
Validation of the Filling and Packaging 1997
Department, including preparation of applicable
SOPs and Process Development for the
Autoclaves.
Validation of the Material Distribution Centre,
including the preparation of applicable SOPs.
Validation of the WFI System for the
Operations Building, including the preparation
of applicable SOPs and the Validation Master
Plan Addendum.
Aventis Pasteur Validation and Non-Strategic Project Support Ongoing
Swiftwater, PA,
• Scope of services include providing an
(USA)
integrated on site Validation Group (6-
10 personnel including a Site Project
Manager) capable of executing on-
going validation projects for a 1 – 2
year period. The SLP team is multi-
disciplinary and specialized in various
equipment / systems and services
specific to this site.
FAT and SAT Commissioning coordination and 2002-2004
execution review and witness for 2 new Large
Scale Production Autoclaves. Preparation and
Execution of IQ, OQ, PQ protocols , as well as
Worst Case Assessment, Cycle Development,
and equivalency studies for over 500 Load
Items categorized within 5 Load Types.
Preparation and Execution of IQ, OQ, PQ
protocols , as well as Worst Case Assessment
and Cycle Development for 2 existing large
scale production Autoclaves, and 1 large scale

27. Client Project Year
production Depyrogenation Ovens.
Various validation projects including system
troubleshooting, various Process Validation
assistance, Report Writing and Data Analysis
and AvP Site Validation Guideline
Development.
Banner Pharmacaps GMP and QC training 2004
Olds, Alberta
Validation of the Production and Containment 1998 to 2000
Facility, HVAC, BAS, Vacuum, Steam, Drying
rooms, BMS and Water systems
Bayer Diagnostics Development of OQ protocols for functional 2003
Mishawaka, Indiana, USA testing of packaging equipment using PLC
ladder logic to force permissive bit for path
analysis and machine interaction verification.
Programming platforms used were RSLogix
500, RSView 32, MachineShop, and 505
Workshop
Bio-Intermediair Inc. Clean Utilities Validation for a new Bio- 1996
Montréal, Quebec pharmaceutical Research & Development
Facility – Purified Water, WFI and Clean Steam
systems
Process and Cleaning Validation
Design of processes for the production of
antibodies using fermentation and purification
processes for components or products resulting
from bacterial fermentation
Biomatrix Process and Utility Validation of the entire plant 1998
Montréal, Quebec
Bristol-Myers Squibb Conformity audit of systems linked with to 2006
Medical Imaging engineering group to propose ventilation and
Dorval, Quebec, (Quebec) laboratory environment improvements
Mississauga, Hamilton, Validation of clean room ventilation systems
(Ontario), Vancouver (BC)
Bristol-Myers Squibb Various projects including: 2002-2007
Candiac, Quebec
Validation of process equipment
Validation of HVAC, clean steam, nitrogen
systems

28. Client Project Year
Change control, SOP writing
Engineering and maintenance department
support
Various projects including: 2001-2003
Construction and validation of the Clinical
Supplies Operation Building, anti-tumor facility
Validation of lyophilizer, dry heat oven and
autoclaves
Qualification for modifications of clean rooms
and pure steam system
Construction and validation of the Clinical
Supplies Operation Building, Packaging and 2002
labeling facility
Validation of the compressed air system,
vacuum system, dust collector system, HVAC
systems, nitrogen system, and Building
Automation System
Construction and validation of the Clinical 1999
Supplies Operation Building, manufacturing
facility
Validation of a new clean compressed air
system and a new house vacuum system
Brunet-Graillon Pharmacy Validation of clean rooms 2006
Gatineau, Quebec
Validation of ventilation systems
Writing laboratory procedures for operation and
Quality Assurance
Canadian Blood Services Validation Projects for various systems and Ongoing
Various locations equipment including: Long Term
throughout Canada Partnership
Development of Corporate VMP.
since 2000
Development of specific Site VPP.
Development of standard protocol templates for
Ultra Low Freezers, Freezers, Refrigerators,
Incubators, Dry Block Heaters, COBE Spectra
Apheresis Unit for global site use.
Development of URS and FRS for COBE
Spectra Apheresis Unit.

29. Client Project Year
Development of URS templates for Freezers,
Refrigerators, Incubators, Agitators,
Centrifuges, Plate Readers, Cryobaths,
Biohazzard Hoods, Fume Hoods, Dead Air
Boxes, Sonicators, Water Baths, Plate Washers,
Bag Sealers, Gamma Cell, Haemonetics PC S2,
Olympus PK 7100/7200, Cell Processor.
Facility Commissioning / Qualification
including HVAC, Fire Suppression, Back-Up
Electrical and Site Security System.
Qualification of Ultra Low Freezers, Freezers,
Refrigerators, Incubators, Centrifuges and Cell
Washers.
Cangene Corporation Expansion of a Biotechnology Manufacturing 2004
Winnipeg, Manitoba Facility Site. Preparation and execution of
Validation Protocols for various systems and
equipment, including:
• cGMP Sterilization Autoclave
• Decontamination Autoclave
• Bioreactors
• Biosafety Cabinets and Laminar Flow
Hoods
• Centrifuges
• Clean Steam System
• Compressed Air Delivery System
• CO2 Delivery System
• Nitrogen Delivery System
• Oxygen Delivery System
• Switch-Over Manifold for Medical
Gases
• Coolers
• Drying Oven
• HVAC Systems
• Filter Integrity Tester
• Controlled Rate Freezers
• CO2 Incubators
• Chilled Water Recirculators
• Hydrogen Peroxide Vapour Generator
• Isolator
• Vacuum Jacket Liquid Nitrogen
Network
• Liquid Nitrogen Storage Tanks
• Vacuum Pump and Network

30. Client Project Year
• Water Baths
• Purified Water System
New Biotechnology Manufacturing Facility. 2002
Preparation of protocols and supervision of
Cangene team during protocol execution of
process equipment, including:
• Bioreactors
• Centrifuges
• cGMP Sterilization Autoclave
• Decontamination Autoclave
• WFI, Pure Steam
• Biosafety Cabinets, Fume Hoods, and
Laminar Flow Hoods
• Media preparation
• SCADA
• HVAC and BMS
New Biotechnology Manufacturing Facility Site 2001
Validation. Preparation and execution of
Validation Protocols for various systems and
equipment, including utilities, reactors, CIP
Skids, Delta V Automated Monitoring &
Control System
Centocor, Inc. Development of Technology Transfer Master 2002
Malvern, PA, USA Plan
CIBA Vision Analysis and revision of all IT SOPs 2004
Mississauga, Ontario
Validation of the Laboratory Management
System Ongoing
Site Validation Master Plan, Equipment since 2003
Validation Master Plan, Process Validation
Master Plan, and Computer Systems Validation
Master Plan document preparation and approach
development.
IQ/OQ/PQ Equipment, Process and Cleaning
Validation Activities for various equipment
including HVAC, Purified Water Systems,
Purified Steam System, Medical Gases, Tanks,
Pumps, Autoclaves, Filling and Packaging
Equipment.
Bulk Product Sterilization - Cycle Development
and Worst Case assessment for approximately

31. Client Project Year
30-40 product types.
Confab Audit of an ERP JDEdwards system Ongoing
St-Hubert, Quebec
Training and support for an FDA inspection
Contract Pharmaceuticals Equipment Qualification –preparation and 1999
Mississauga, Ontario execution of IQ/OQ protocols for the
Manufacturing tanks, Homogenizers, Pumps,
Mixers, Liquid Fillers, Bottle Unscramblers and
Plastic Tube Fillers
CV Technologies Quality assurance system assessment of the Ongoing
Edmonton, Alberta potential vendor/supplier
Dermolab Validation of 3 ventilation systems, 2004
Ste-Julie, Quebec thermopump and compressed air system
(IQ/OQ/PQ)
Draximage Process Validation 1999
Montréal, Quebec
Draxis Pharma Inc. Development of a terminal steam sterilization 2005
Montréal, Quebec cycle
Validation of the production autoclave control
system following program upgrade
Validation projects for various systems and 2003-2004
equipment including:
• Qualification of a large-scale
lyophilizer (including CIP/SIP
capabilities) and automatic vials
Loading/Unloading system
• Autoclaves (2 units) and drying ovens
(2 units).
• Autoclave cycle development
• HVACs, Laminar flow Hoods and
dispensing booths.
• SOP writing/training for many different
systems and equipment.
• Validation of Computerized systems.
• Qualification of packaging equipment.
• Qualification of a Pure Steam system
and nitrogen system.
• Qualification of container washing
machines, filling / stoppering / capping
machines, and manufacturing

32. Client Project Year
equipment.
DSM Biologics Compliance Upgrade Project to modify existing 2004
Montréal, Quebec Quality Systems for an existing Biotechnology
facility. Services includes Training Program
and SOPs Program.
Validated equipment and systems:
• Bioreactors
• Media Prep.
• Computer validation
• SCADA and BMS
• Maximo.
Personnel loan for QE department of
replacement of their QA Manager and
involvement on QC tasks.
Large Scale Expansion Project for a new facility 2003-2004
for contract manufacturing of BL-1 monoclonal
antibodies and recombinant proteins by cell
culture. The facility will be mainly used for the
production of Phase III and commercial drug
active ingredients. Validation services included
the following:
• Preparation and coordination of the
User Requirement Specifications
• Preparation and completion of the
Enhanced Design Review Process
• Review and coordination of Functional
Specifications
• Preparation and completion of a FAT
and SAT template
These services were provided for the following
systems:
Upstream Process Equipment:
Seed Bioreactor & PLC 30 L,
Seed Bioreactor & PLC 150 L
Seed Bioreactor & PLC 750 L
Seed Bioreactor & PLC 3000 L
Production Bioreactors & PLCs 12 500 L
Feed Tank 2500 L
Feed Media Addition Tank 4000 L
Bioreactors CIP & PLC
Process Tanks

33. Client Project Year
Process Tank PLC’s 4
Media Preparation Tanks & PLC
Centrifuge & PLC
Ultrafiltration & PLC
Detergent holding / Distribution
CIP Skids & PLC’s
Process Transfer Piping
Downstream Process Equipment:
DSP Pre-Virus Chromatography Skid & PLC
DSP Pre-Virus Chromatography Column
Pre-Virus Packing Station & PLC
DSP Post-Virus Chromatography Skids & PLC
DSP Post-Virus Chromatography Column
DSP Post-virus Packing Station & PLC
DSP Post-virus TFF Ultrafiltration
Dead-end Filtration
Buffer Preparation Tanks & PLC & Small
Buffer Preparation and Acid-Base Tanks
Buffer Holding Tanks &PLC
Caustic (NaOH) Tank & PLC
Facility Utilities:
HVAC Systems
Emergency Power
Building Automation Systems
Walk-in Refrigerator/Freezer
Clean Utilities:
Pure Steam Generator
Clean Air Compressors
WFI System
Decontamination & Neutralization & Process
Drainage System & CIP
Medical Gases (O2, N2, CO2)
Supporting Equipment:
GMP Autoclave
Decontamination Autoclave
Double Door Washer
Laminar Air Flow Hoods
Bio- Safety Cabinets
Incubators

34. Client Project Year
Liquid Nitrogen Cell Bank Freezers
Fast Freezer
Refrigerator / Freezer
Chemical Fume Hoods
Process Control System:
Engineering Workstation
Security and Historian Backup Server
Historian and Trending Server
SCADA Server – Train No. 2
Batch Management Server
I/O Directory Server
Network
Server Room
Process Control Supervisory System
Process Transfers
CIP Transfer
Security Access Cards
Several Validation Projects for various systems 2000
and equipment, including: compressed air,
nitrogen, steam, BAS, purified water, WFI,
softened water and equipment process skid,
incubator, still
Eli Lilly Computer Validation of a SCADA system 2005
Puerto Rico
Eli Lilly Validation of a custom developed LIM System 2003
Indianapolis, IN, (USA)
Preparation for a FDA Inspection 2001
Eli Lilly Validation of a Building Monitoring System Completed
Toronto, Ontario
Ethypharm Ensured full compliance with regulatory 2002
Laval, Quebec agencies, MCA & FDA for two facilities. This
included:
• Prepare and perform internal audits
• Revise the documentation related to the
QA system
• Evaluate the validation status of the
systems and equipment
• Preparation of the Validation Master
Plan for the Laval site and the site in
France

35. Client Project Year
Ethypharm QC revision and audit to conform to European 2003
Mumbai, India GMP
Ethypharm GMP training 2003
Chateauneuf-en-thymerais,
France
Ethypharm New FDA Audit 2002, 2004
Grand Quevilly, France
Two Compliance experts on site for18 months. 2001-2003
This included:
• Perform Pre-inspection audit FDA and
EU
• Support internal QA and optimization
of procedures
E-Z-EM Regulatory affairs support 2006
Montréal, Quebec
Federa/ Cardinal Health Validation leader of the new NOH Filling 2006
Brussels, Belgium Facility in Brussels including:
• Water system
• Ventilation systems
• Processing equipments
• Cleaning validation
• Computer validation
Production department leader
Documentation training
Validation of laboratory equipment: 2004
• Particle counter and software
• Chromatograph
• HPLC and software
• Spectro UV and software
• TOC and software
• Automatic titrator
• Mass spectrometer
• Insulators
• Insulator sterilizer
Production files optimization and support
Site Master File Validation
Galderma Production Various projects including: 2005-2006
Montréal, Quebec
• Cleaning Validation, Cleaning matrix
• Process Validation

36. Client Project Year
Various Projects including: 1999
• Validation of the Production Skids;
Validation of the Temperature Control
Room
• Plant and Process Qualification
• Preparation of SOPs
Gambro Conformity and process support for a medical 2005
Montréal, Quebec device company
Genpharm Inc. Various projects including: 2001
Etobicoke, Ontario
Packaging Line & Manufacturing Equipment
Validation for a Solid-Dosage Manufacturing
facility
Preparation of IQ/OQ/PQ protocol for
compressed air systems
Qualification of vaults and security system used
in storing controlled drugs
Preparation of two (2) Validation Master Plans:
for Manufacturing Equipment/Systems and for
Utilities Systems
Autoclave Validation
GlaxoSmithKline Validation of various systems, utilities and 2006-2007
Ste-Foy, Quebec equipment for a Biotechnology Manufacturing
Facility to conform to BSL2+
Validation of systems and equipment for the
Seed Preparation and QC laboratory to conform
to BSL2+
Validation of air units to conform to BSL2+
Validation of systems, utilities and
production/process equipment for production
capacity increase conform to BSL2+
Project coordination of all stages from the end
of construction to completion of validation on
behalf of the client, for the BSL2+ upgrade and
production capacity increase
Cleaning Validation of process equipment, CIP 2005-2006
system

37. Client Project Year
Validation of process equipments and systems
Computer related system (CRS) assessment
Commissioning of various utility systems
Project coordination for the installation,
commissioning and validation of various utility
skids
Preparation and execution of IQ/OQ/PQ and 2003-2004
SOPs for various systems and equipment for a
Biotechnology Manufacturing Facility:
• Laboratory, Manufacturing and
Packaging equipment (fillers, stoppers,
cappers, Inoculators, Harvester,
Transfer Panels, Centrifuges,
Inactivation UV systems, Autoclaves,
Incubators, Refrigerators, Laminar Air
flow hoods)
• Qualification of several utility systems,
(HVAC, Clean Compressed Air, USP
Water, and Pure Steam)
• Qualification of environmental
monitoring program
• Qualification of the Central Archiving
System related to process equipment
monitoring.
Documentation review for the QA department
GlaxoSmithKline Commissioning and Validation of Quality 2006-2007
Laval, Quebec Control equipments and HVAC systems to
conform to BSL2+
Cleaning validation
LV-01 (Bldg 15) (2006):
Validation of HVAC and process equipment to
conform to BSL2+ (2006)
Cleaning Validation
LV-02 (R&D Environment) (2007):
Validation of HVAC in a BL-3 environment, of
a purified water system
Writing of a Validation Master Plan for a BL-3
environment

38. Client Project Year
Validation of New Building 15; EPCMV project 2005
Building upgrade; Addition to the ventilation
systems and purified water system
Commissioning and Validation of process
equipment and utilities
Preparation and execution of Commissioning 2003-2004
protocols, IQ/OQ/PQ and SOPs for various
systems and equipment for a Biotechnology
Manufacturing Facility:
• Laboratory, Manufacturing and
Packaging equipment (fillers, stoppers,
cappers, Inoculators, Harvester,
Transfer Panels, Centrifuges,
Inactivation UV systems, Autoclaves,
Incubators, Refrigerators, Laminar Air
flow hoods)
• Qualification of several utility systems,
(HVAC, Clean Compressed Air, USP
Water, and Pure Steam)
• Qualification of environmental
monitoring program
• Qualification of the Central Archiving
System related to process equipment
monitoring.
Documentation review for the QA department
GlaxoSmithKLine Assessment, preparation of a remediation plan 2006 - 2007
Hamilton, US and implement the remediation plan of
computerized systems.
Existing computerized system SOPs upgrade to
meet new corporate requirements.
Validation assistance for the Engineering
department to complete validation activities and
document and resolve pending validation
deviations.

39. Client Project Year
GlaxoSmithKline EPCMV of a new building 2005-2006
Biologicals (WN-128)
Writing of commissioning documents and the
Wavre Nord, Belgium writing and execution of validation protocols,
including:
• HVAC systems for laboratories (41
systems including BL-2 and BL-3), cold
rooms (20 units) and incubators
• Bench LAF, Pass-Boxes, Process Tanks
• Utility Systems (Process compressed
air, Process steam generator and
distribution circuit, CEC –
decontamination station, EDI –
demineralised water, EPI – industrial
clean water, CIP, SIP)
• PEMS – Process Environmental
Monitoring System
• Washing machines (2 items)
• Sterile autoclaves (4items)
• Decontamination autoclaves (8 items)
GlaxoSmithKLine Validation of process services, clean building 2004
Biologicals (WN-119) utilities, vaccine production
Belgium
GlaxoWellcome Design Qualification Summary and Review of 1998
Mississauga, Ontario the USP Water System for the Mepron &
Malarone Manufacturing Suite
Héma-Québec Preparation of a validation master plan 2003
Montréal, Quebec
Hemosol Inc. Validation services for a new commercial 2000-2003
Mississauga, Ontario facility to manufacture a blood product
extracted from expired human blood. Services
include the preparation of the VMP; preparation
and execution of DQ/IQ/OQ/PQ protocols for:
• Customized process equipment skids
• SCADA
• Customized software systems
• Network infrastructure
• Utilities including several HVAC
systems, Compressed Air system,
Medical Gases (Nitrogen & Oxygen)
Systems, WFI, Clean Steam System,
Purified Water System

40. Client Project Year
• Building Automation System
• Autoclaves
Hemosol Inc. Review of existing critical utility systems and 2001
Toronto, Ontario the applicable documents in preparation for a
Pre-approval Inspection.
Validation services for the Scale-up Plant,
including the preparation and execution of
IQ/OQ/PQ protocols, preparation of SOPs and
Process & Cleaning validation for the associated
systems, equipment and processes.
Homeodel Conformity Audit Ongoing
Montréal, Quebec
Regulatory affairs support
Training on GMP for natural and health
products
Intelligene Expressions Inc. New Fermentation Plant 1998
Edmonton, Alberta
Johnson & Johnson Medical Walk-in Cooler Validation – preparation and 2000
Products execution of IQ/OQ protocol, including empty
Markham, Ontario chamber and loaded chamber temperature
mapping, data analysis and final report
Preparation of the required documents for the 1999
Qualification of the Distribution Warehouse
Temperature Control
JSS Medical Research Conformity Audit 2006
Montréal, Quebec
Training on the validation lifecycle:
development of URS, FS, DS, Programming
Standards, IQ, OQ, execution of IQ and OQ.
Providing support to achieve compliance to 2004
their site’s quality assurance system with
applicable regulations.
Project scope of services includes:
• Giving training sessions to update JSS
personnel on computer validation and
21 CFR 11 basic requirement, Good
Clinical Practices, and Good
Documentation Practices.
• Writing of a Quality Master Plan

41. Client Project Year
• Support for computer system and
computer validation
• Support for Quality Assurance
Knowlton Packaging Conformity Audit in microbiology Ongoing
Knowlton, Quebec
Computer Validation Master Plan and
Assessment of an ERP system
Labopharm Validation of pilot production equipment in the 2006
Laval, Quebec laboratories for:
• Press Stokes 560 (#PRE-04)
• Metal detector device in tablets
• De-duster
Validation of pilot production equipment in the 2004
laboratories for:
• Korsch Tablet Press
• Korsch Compression Research System
– Computer Interface
• Glatt Fluid Bed Dryer
• Vector Laboratory Development
Coating System
• Pk Blend Master V-Blender
• Single Stroke Stokes F4 Tablet Press –
Powder Compacting Press
• Quadro Comil
• Glatt High Shear Mixer
• Manesty Drycota 23 Station
• Cap Seal Jr. Induction Heating
Generator
LBVA-Veterinary and Food New Biotechnology Manufacturing Facility 2003-2007
Biotechnology Laboratory, Site.
Faculty of Veterinary Preparation of a compliance report and
Medicine, Université de presentation to the applicable regulatory
Montréal agencies of Canada and USA.
St-Hyacinthe, Quebec
Preparation of various Standard Operation
Procedures for systems, equipment and
programs
Preparation of the Site Validation Master Plan,
preparation and execution of Validation

42. Client Project Year
Protocols for various systems and equipment,
including:
• Building Automation System (BAS)
• Classified clean rooms
• HVAC Systems
• USP Purified water
• Pure steam
• Water For Injection
• Clean compressed air
• Medical gases: CO2
• Medical gases: N2
• Medical gases: O2
• Biological safety cabinets
• CO2 and standard Incubators
• Fermenters
• Refrigerators
• Freezers
• Pumps
• Sterilizing autoclave
• Glassware washer
• Freeze dryer
• Process tanks
• Transfer pump
• 4°C room/quarantine
Les Laboratoires Aeterna Validation of the HVAC system and utilities in 1999
Sainte-Foy, Quebec the Manufacturing Plant
Les Laboratoires Riva inc. EPCMV (Engineering, Procurement, 2005
Blainville, Quebec Construction Management, Validation) of a new
USP purified water system – IQ/OQ, PQ
Malinckrodt Validation of Process Equipment 1997
(USA)
Margo Inc. Validation of filling and packaging equipment 2002
Division of the Alcan Group including protocol preparation and execution:
Jamesburg, NJ & • Tube Fillers
Bethlehem, Pennsylvania • Autoclave, including Operation &
Maintenance SOP
Validation services for a new contract
packaging facility including preparation of:
• Validation /Cleaning Master Plan
• Facility validation protocols IQ/OQ/PQ

43. Client Project Year
for: HVAC, CA, BAS, Vacuum
• SOPs for HVAC, CA, BAS, Change
Control
• SOPs for the Validation approach,
Computer system periodic review,
Security of computer system and back-
up and recovery
Martec Pharmaceutical Validation of a New Solid Dosage Production 1996
USA Facility, including the preparation of the
Validation Master Plan; the Presentation of the
VMP to the FDA authorities; preparation of the
applicable Operation, Maintenance, Cleaning
and Calibration SOPs; and validation of various
Pilot Plant equipment
Martec Scientific Process Equipment Validation 1997
(USA)
McNeil Consumer Products Consumer Products Facility - Validation of the 1997
Guelph, Ontario HVAC and Building Automation systems and
Incubator Mappings
MDS Nordion Inc. Preparation of the KRMF Phase 2 VMP, VPPs 2003
Kanata, Ontario (Facility, Component Preparatory Room and
(Long Term Partnership Paragon Manufacturing) and Facility
from 1997-2003) Commissioning Master Plan.
Qualification of the Component Prep WFI
system, DI system, Particle Monitoring System,
Autoclave, VHP unit, Vial Washer, Glassware
Washer, Stopper Processor and Bag Sealer.
Facility Qualification including HVAC, BAS,
Architecture, Clean rooms and medical gases.
Project Management for the Validation and
Compliance activities required to achieve FDA
approval for a Radiopharmaceutical Cancer
Therapy.
Preparation and delivery of a Training Session 2002
on the GAMP 4, including CFR 21 Part 11
Compliance Update.
Preparation of protocols and SOP for the
qualification of a Vaporized Hydrogen Peroxide
insert.

44. Client Project Year
Documentation Review of Processes and 2000
Equipment for GMP and adherence to
Validation Guidelines, for mechanical systems,
production and QC testing equipment used in
the manufacturing and testing of radio-
pharmaceutical products.
Project Management for the validation and
compliance activities required to achieve FDA
approval for a Radiopharmaceutical Cancer
Therapy.
Validation of the Manufacturing Operation of
isotopes for Radiopharmaceutical applications –
preparation of protocols and the review of
documents for various systems and equipment.
MDS Pharma Services Validation of a Clinical Trial Database System 2006
Mississauga, Ontario
Various Computer Validation projects, which 2003
include:
• Compliance Audit for Clinical Trial
Database System
• Preparation of report detailing
remediation activities for the database
system
• Preparation of Test Plans for
customized interfaces
• Preparation and execution of Test
Scripts for customized interfaces
MDS Pharma Services Development of a management system for the 2006
St-Laurent, Quebec revision of 5 years of clinical studies results and
information
Computer Validation (PQ software system)
Medicago Training on validation 2006
Ste-Foy, Quebec
Conformity Audit
Validation and commissioning of HVAC system
Merck Frosst Canada Validation of laboratory equipment: Karl Fisher 2002
Montréal, Quebec Titrator
Compressed Air Renovation Qualification 2000
Various Projects, including: 1999
• Qualification of the Quality Operation

45. Client Project Year
(QO) Building
• QO Building - Autoclave and Incubator
Qualification
• Training Documentation for the QO
Facility
• Track 3 – Qualification of the USP
Water System
• Mogensen Sizer Qualification; Kady
Mill Qualification
Building 2 – Building Automation System 1998
Process Equipment Qualification
QO Building – BAS Qualification Preparation
of the Standard Validation Format for the BAS
system
Cold Room Distribution Centre Lot 3 1997
BAS Qualification – Phases I and II
Lot 4 – Vacuum and Drainage Systems
Validation of the Clinical Supplies Packaging 1996
Building, including the preparation of the
Validation Master Plan and preparation of
applicable SOPs
Pilot Plant, Clinical Production 1993
Merck Sharp & Dome Packaging Plant Validation 2000
(South Africa)
Methapharm Validation services for the qualification of the 2003
Brantford, Ontario new Glovebox and the Powder Filling System
Novartis Pharmaceuticals Preparation of SOPs for large scale production 1998
(USA) equipment and Process Automation system
Compression/Encapsulation Department – 1997
Statistical Process Control project
Novex Pharma Validation projects for various systems and 2003
Richmond Hill, Ontario equipment, including:
• VHP Generator
• HVAC system
Non-sterile Filling Line – Commissioning and
IQ/OQ/PQ for monoblock filler, capper,
crimper, labeler, checkweigher, cartoner and