ProPharma Group is an industry leader providing qualification, compliance and technical services to life sciences companies to help improve their operations and maintain quality leadership in a changing regulatory environment. They understand that clients are driven by aggressive timelines and are comfortable working in such an environment while maintaining strong integrity and commitment to compliance. ProPharma Group assembles project teams with the right combination of project management and technical skills to successfully lead projects and ensure each project has the best possible team.

1. Life Sciences

2. ProPharma Group is an industry leader providing ProPharma Group is built on the
qualification, compliance and technical services to the foundation of developing long-term
pharmaceutical, biotechnology and medical device relationships with clients. With this
industries. We focus on enabling our customers to in mind, each project starts with a
improve their operations, revitalize their facilities, and client kickoff meeting to correctly
maintain quality leadership in a challenging and changing understand the project goals, timelines
regulatory environment. We understand that our clients and limitations. Together we develop a
are driven by aggressive timelines and are comfortable project plan and determine the critical
working in such an environment while maintaining a strong factors for success.
integrity and commitment to compliance.
focus foundation
expertise challenges
Our compliance, validation and scientific
professionals have expertise in biology,
chemistry, engineering, information technology,
We assemble our project teams
manufacturing, project management, quality
to best meet the needs of the
assurance and quality control. The majority
client. Each project manager has a
of our staff’s experience comes from working
combination of project management
directly for operating companies, so they
and project-related technical
understand the unique concerns and challenges
abilities to successfully lead a
that are faced in a regulated environment.
cross-functional team. The broad
We attract talented people to our organization
array of our technical expertise,
by offering competitive benefit packages and
our institutional knowledge base,
creating an atmosphere that fosters a long term
and the size of our consulting staff
relationship between our colleagues and our
ensures that each project has the
clients. This long term perspective guides us day-
best possible team.
to-day to make the right decisions for both our
clients and colleagues.

3. ram Manageme
Prog nt
Commissioning & Integrated
Qualification Services
Computer
Cleaning Systems
Validation Validation
Project
Management
Process
Analytical Compliance
Technology (PAT) Services
Consulting
Process Laboratory
Validation Services
our services

4. Commissioning & Qualification
Commissioning Services Qualification Services
Commissioning is a well planned, documented and Validation Master Plans
managed approach to the start-up and turnover of ProPharma Group regularly develops both site
facilities, systems and equipment to the end-user Master Plans and project-specific Validation
that results in an operational, safe, and functional Master Plans. Our plans guide the entire project
system that meets established design requirements team toward the identified goals related to a
and end-user quality expectations. facility that can be validated in compliance with
Following current industry standards, such as ASTM all applicable regulations.
E 2500 and those from ISPE, ProPharma Group Installation Qualifications
can provide commissioning documents that verify
ProPharma Group is proficient in writing and
proper installation, operation at start-up, functional
performing Installation Qualification protocols
performance, and turnover of facilities, systems and
to ensure that the equipment received is in good
equipment. Our commissioning services include:
condition, as designed, and properly installed in
• Developing and executing commissioning plans the manufacturing environment.
that support the overall project schedule
Operational Qualifications
• Developing commissioning documents (e.g. User
We work together with our clients to develop and
Requirement Specification, inspection forms,
execute Operational Qualification protocols that
Factory Acceptance Tests and Site
ensure process equipment and ancillary systems
Acceptance Tests)
are capable of operating within established limits
• Inspecting for physical completion and tolerances.
• Vendor audits Performance Qualifications
• Witnessing vendor commissioning activities ProPharma Group validation consultants
• Managing the commissioning activities of have extensive experience with performance
vendors, construction contractors, owners, and qualification of facility systems such as HVAC,
contract resources. WFI, and process gas.
• Executing commissioning activities for utility
and process equipment systems in a manner
that maximizes opportunities for leveraging with
qualification activities.

5. Computer Systems Validation
Our computer validation group can assist you with the
complete life cycle of services associated with Computer
System Validation. We offer the following services:
Specification Development Commissioning, Qualification and
We can assist you in the development of computer Validation Services
system documentation in compliance with industry We can provide document development and
standards as well as Good Automated Manufacturing execution services for computer hardware or
Practices® (GAMP), including: software systems large or small. These
• User Requirements Specifications (URS) services include:
• Supplier/Vendor Audits • Factory Acceptance Testing (FAT)
• Functional Specifications (FS) • Site Acceptance Testing (SAT)
• Design Specifications (DS) • Commissioning Testing
• Validation Master Planning (VMP) • Installation Qualification (IQ)
• Software Development Life Cycle (SDLC) • Operational Qualification (OQ)
• Performance Qualification (PQ)
System Design Services
• Requirements Traceability
Our professionals are trained to provide a full
System Type Expertise includes the following:
gamut of design services ranging from the initial
concept through full system integration. Available • Building, Facility, Utility Systems
services include: • Infrastructure
• IT Applications
• Design Review
• Laboratory Systems
• Unit Testing
• Process Control Systems
• Integration Testing
• Enterprise Level Systems
• System Testing
System Procurement and Installation Customer Support and Training
Our organization can assist in solutions for any Our team is available to provide on-going system
size system including: support and training services to supplement your
company’s personnel resources including, but not
• Project Management
limited to:
• Gap Assessment
• Risk Assessment • Backup and Recovery
• Vendor Leveraging • Data Archiving
• Continuity Planning
• Disaster Recovery
• Periodic System Reviews
• Surveillance Audits
Good Automated Manufacturing Practices® (GAMP) is • ISO/QMS Reviews
a Registered trademark of the International Society for • Best Practices Training
Pharmaceutical Engineering.
• SOP Development

6. Program Management
• portfolio mangement
• early & late stage
drug/device development
• technology transfer
Program Management creates a centralized, high-level
management platform to Assess, Plan and Execute complex
programs that typically including multiple projects, each
with timelines critical to getting your drug/device to market
faster. ProPharma’s Program Management services provide
solutions to your needs in:
• Portfolio Management
• Early and late stage drug/device development
• Technology Transfer

7. Program Management
Our value-added services are offered in response ProPharma Group brings to the table its multi-
to challenges that companies routinely face disciplinary team that has a ready-to-use
with moving a novel drug/device through the Toolbox of proven Project Management tools,
development continuum, transferring technologies required strategic knowledge, hands-on industry
between their manufacturing and partner sites, and regulatory experience, management and
or outsourcing manufacturing to a Contract communication skills, and qualified Subject Matter
Manufacturing Organization (CMO). Experts that contribute to the success of your
Program success is contingent upon having clear program. By integrating performance measures,
definitions and a concise strategy to provide a benchmarks and goals, organizational performance
framework for building a Project Plan, including is monitored, measured, optimized and improved.
developing a realistic schedule while understanding We can spearhead the due diligence process to
the risks involved. The Program Team must be answer critical questions and help you plan for, and
capable of filling key roles and providing support for reach a successful outcome, on time and within
corporate processes in drug/device development budget. ProPharma Group’s Program Management
and technology transfer. ProPharma Group’s Services drive the process; improving your
Program Management Services drive the process organization’s performance, providing sustained
forward, improving an organization’s performance momentum to meet the organization’s goals, and
and ability to meet program goals. These services doing what is right for the business.
include:
• Portfolio and Risk Management
S T R A T E G Y
• Project Prioritization
• Cross Project Planning and Scheduling
PROGRAM MANAGEMENT PROCESS
• Resource Planning
• Budgeting
• Communications Management Project Risk
Goals
• Quality Management Benefits Scope Changes
(Time, Cost, Quality)
• Development of the Program Management
Organization (PMO)
Initiate Plan Execute Close
P R O J E C T
P R O J E C T
• Performance Management
• Project Management Monitor &
Control
• Project Management Training
• Program Lifecycle Management Project Management

8. Compliance & Quality Assurance
ProPharma Group realizes that the Standards and Regulations
identification of Quality Assurance (QA) ProPharma Group’s senior staff of quality,
and Compliance problems is only part compliance and program/project management
of the Compliance Puzzle; knowing professionals takes a proven, hands-on approach to
what to do about them to mitigate your addressing our clients’ specific QA and Compliance
situations to assure that their quality and regulatory
compliance risk is the key! As a provider
operations are in compliance with current industry
of turn-key solutions, ProPharma Group standards and FDA/international regulations, such as:
offers the following value-added QA and
Food and Drug Administration (FDA)
Compliance services:
• Current Good Manufacturing Practice (GMP) Regulation
Quality Assurance for Finished Pharmaceutical Products – 21 CFR Part
210/211
Our QA staff has extensive experience in regulated
• Quality System Regulation (QSR) for Finished
environments and brings this value to the table when Devices – 21 CFR Part 820
assisting our clients’ with their QA-related needs. • General Biological Products Standards – 21 CFR
QA/QC Staff Augmentation Part 610
• Electronic Records; Electronic Signatures – 21 CFR
• Policy, SOP and Batch Record Review,
Part 11
Preparation and Optimization
• Good Laboratory Practice (GLP) Regulation – 21 CFR
• Quality System (QS) Development, Part 58
Assessment and Optimization • Guide to Inspections and Guidance For Industry:
Miscellaneous
• QS Auditing / Benchmarking
International Regulatory Agencies
• Corrective and Preventive Action (CAPA)
International Conference on Harmonization (ICH)
Planning and Execution
• Validation of Analytical Procedures – ICH Q2
• Training – FDA, GMP QSR, Validation,
, • GMP Guide for Active Pharmaceutical
Operator, Safety, etc. Ingredients – ICH Q7
Compliance • Pharmaceutical Development - ICH Q8
• Quality Risk Management – ICH Q9
Our Compliance staff augments our clients’ internal
• Pharmaceutical Quality System – ICH Q10
capabilities to prepare for, execute and address
compliance-related observations and deficiencies, European Union Guide to Good Manufacturing
Practices (Eudralex)
thus mitigating our client’s regulatory risk.
International Organization for Standardization (ISO)
• Third-party GMP and GLP Compliance
• Quality Management Systems – ISO 9000 and
Auditing ISO 9001
• Mock FDA/International Regulatory Agency • Medical Devices – Quality Management Systems –
Inspections and PAI Auditing Requirements for Regulatory Purposes – ISO 13485
• Due Diligence Compliance Inspections, Pharmacopeias
Audits and Assistance United States, European, Japanese
• FDA Action (483 Observations, Warning Industry Standards
Letters, Consent Decrees) Remediation • Good Automated Manufacturing Practice (GAMP 5)
• PIC/S, WHO, PDA, ISPE, ASTM Standards, Technical
Reports and Guidance

9. Laboratory Services
Our FDA registered laboratory provides validation related and
routine testing support based on sound scientific methodologies
and delivers the highest quality of service within compliance of
worldwide GMP regulations and guidelines. External audits are
welcomed and encouraged.
Laboratory Services
Total Organic Carbon (TOC) pH/Conductivity
Advanced automated features and our high-capacity We use the USP the standard methodology for
Autosampler combine for an unequalled level of conductivity testing of Water for Injection (WFI),
efficiency, allowing us to promptly provide accurate purified water and clean steam.
results. The TOC methodology can be validated per
USP and ICH Q2 guidance to demonstrate that it is Growth Promotion
suitable for use with your compounds. We are capable of performing growth promotion testing
on an extensive array of biological media types. The
Endotoxin (LAL)
duration of incubation, temperature and evaluated
LAL is a highly sensitive and specific assay used organism species can be customized according to
to screen water, clean steam, raw materials and your specific growth promotion requirements.
finished product for the presence of endotoxin.
To produce quantitative endotoxin values, we use Microbial Limit Testing
the Kinetic Turbidimetric Method. Our integrated We provide method development, method validation
software and instrumentation make it possible and routine testing services to quantify and monitor
for us to provide fast, accurate results for every for objectionable microbiological contaminants.
sample tested.
Applications
Total Microbial Count (Bioburden)
• Water systems qualification
Testing for bioburden in water systems, raw • Environmental monitoring
materials and final products is necessary to • Cleaning validation
determine compliance to compendial requirements. • Disinfectant qualification
We test for bioburden per the USP pour plate and • Raw material and finished product
filtration methods. • Microbial media growth promotion
• Water system assessment
Microbial Identification
• Routine and investigational utility and
We are able to identify environmental isolates, environmental testing
pathogens, spoilage organisms, control strains and
media fill contaminants.

10. Process Validation
Process validation is defined as establishing We can review your development reports to assist
documented evidence that a specific process in the determination of critical process parameters
will reliably and consistently produce a product and quality attributes, and use this review to
that meets its predetermined specifications and develop scientifically justified validation plans, which
quality attributes. Processes could encompass demonstrate consistency and reliability in processing.
manufacturing, filling, sterilization, and packaging We can also assist you in developing statistically
within the FDA regulated pharmaceutical, justified in-process and finished product sampling
biotechnology, API and medical device industries. strategies. Knowledge of the critical processing steps,
quality attributes and sampling strategies allows
ProPharma Group employees have experience our process validation engineers to challenge the
validating processes in all aspects of the FDA robustness of the process during the development
regulated industries. and execution of the validation studies.
Process Analytical Technology (PAT) Consulting
ProPharma Group has combined its extensive Develop: By working together with you, we select and
background in process validation and control develop the solutions identified in the action plan.
systems to offer a complete PAT solution to clients. Solutions could include process instrumentation,
Dating back to 1998, ProPharma Group has helped analytical software, quality procedures and multi-
clients bring their pharmaceutical manufacturing variate analysis.
processes online to provide valuable information as Implement: We’ll help you install, validate and go live
production occurs, spanning everything from raw with each solution. We team with your resources to
materials to batch release. perform such tasks as commissioning, qualification
ProPharma Group has developed a four phased and training.
approach to addressing the PAT Initiative, based Monitor: We advise you on how to best monitor your
on the key principles defined by the FDA: implemented PAT solutions to ensure you are getting
Investigate, Develop, Implement and Monitor. We the results you need. We also help you decide when
see these four phases as cyclical as true compliance to return to the investigation phase and continue on
with the PAT Initiative is attained. the four phase cycle.
Investigate: We begin with an investigation into your ProPharma Group has assembled a team of consultants,
current processes and systems in place to control, partners and specialized experts to work together with
monitor and ensure quality of these processes. We you to understand and implement Process Analytical
then recommend an action plan. Technology solutions.

11. Cleaning Validation
The prevention of cross contamination is an ProPharma Group has the expertise to guide you
essential component of any GMP program and is through the cleaning validation process.
necessary to ensure the safety of drugs, biologics
We are experienced at developing and executing
and medical devices used in human or veterinary
validation master plans and protocols abreast with
applications. A major source of contamination risk
current industry standards. We provide a hands-on
to these products is in the form of carryover of
group of professionals that can guide you through
compounds and cleaning agent residues from the
the details of establishing a cleaning master plan,
previous manufactured product or cleaning process.
setting residue acceptance criteria, preparing
Properly designed and executed cleaning validation
a comprehensive sampling plan and validating
studies ensure that the process removes product
and utilizing appropriate analytical methods with
and cleaning agent residues from product contact
sufficient sensitivity for those unique processes
surfaces to an acceptable limit.
and equipment.
Integrated Services
Our Integrated Services provide you peace of mind by having
us manage all of your current challenges to deliver projects in
compliance, on time, and in budget. These services include:
• Automation • Quality Audits
• Compliance Consulting • Standard Operating Procedures (SOPs)
• HEPA Filter Certification • Software Development
• High Purity System Piping QA/QC • Test and Balance
• Information Technology Solutions • Training
• Project Management
For a complete list of our Integrated Services, refer to our website at
W W W. P R O P H A R M A G R O U P. C O M

12. W W W . P R O P H A R M A G R O U P. C O M
(888) 242-0559