1. Quality Documentation System
This Quality system has been developed for the GMP Bioprocessing Training and Production facility on
UCC campus by Patrick O’Flynn as part of his MSc in Biotechnology project.
Figure 1 - Overall view
The system is divided into 5 folders as can be seen in Figure 1. The documentation contained within each of
these is outlined in the following pages. The aim of the system is to aid in the efficient organisation and
administration of operations at the GMP Bioprocessing Training and Production facility. It has been devised
from WHO guidelines on GMP documentation.
The basic principal is that every operation or action in the facility has a Standard Operating Procedure (SOP)
and a corresponding Data Record Form (DRF) where appropriate. A simple example is an Equipment
Operating Procedure (EOP) and the corresponding LUMAC Logbook for that piece of equipment. A
document numbering system is used for each category of document to keep track of all approved documents.
The system has been generated in an electronic format but it will be applied to the process in a hard copy
format. All documentation will have to be printed and approved prior to their application. Master copies of
SOPs will be printed on white paper and filed in the main office. Draft Copies will also be printed on white
paper but will be rubber stamped to signify their draft status. Copies of SOPs must be approved and signed
for prior to distribution. These will be printed on green paper and must be returned to the main office when
no longer needed or if the master copy undergoes a revision. These copies must then be destroyed for
security and privacy purposes. See the Directories and Document Control subfolder of the Quality
Assurance Folder for details.
The major document of the facility is the Validation Master Plan (VMP). This outlines all validation
operations in the facility and gives a strong indication of the general attitude towards quality. During
inspections, a facility’s VMP is often seen as a representative document for the quality system in place and
is the most heavily scrutinised for this reason. The VMP is to be kept in the main office and filed in the
Validation and Change Control subfolder of the Quality Assurance folder.
Documentation for GMP facility
Facility Equipment Production
Quality
Control
Quality
Assurance

2. Figure 2 - Focus on Facility
The Facility Folder is designed to hold all documentation pertaining to the facility itself (building and
utilities). This is visually illustrated in Figure 2. Note the sub-folders. The contamination control plan and all
its procedures and data record forms will be documented here.
The “Systems” folder holds all SOPs regarding the Operation, Maintenance and Calibration of utilities in the
facility. This includes procedures regarding the HVAC system and purified water loop as well as aseptic
sampling of process equipment such as a the Bioreactor.
The “Cleaning of Facility”, “Disinfection, Fumigation”, “Environment Monitoring” and “Pest Control”
folders hold SOPs, DRFs and Logbooks regarding each of their relevant topics.
The “Flow Plans” folder contains details for the flow of product, supplies, staff and waste disposal. This
includes flow plans and diagrams. See the Validation Master Plan for details regarding these activities too.
The “Cleaning and Sterilisation” folder contains SOPs for the cleaning and sterilisation of materials that will
come in direct contact with the product. These materials must be more stringently cleaned and maintained as
their direct contact with the product has a direct impact on product quality.
The “Access Control and Hygiene” folder contains a number of SOPs outlining activities such as Access
Control, Hygiene, Gowning, Degowning, Material Transfer and Personnel Conduct.
Documentation for GMP facility
Facility
Systems
Operation,
Maintenance,
Calibration
Cleaningof
Facility
SOPs, DRFs
andLogs
Disinfectant,
Fumigation
SOPs, DRFs
andLogs
Environmental
Monitoring
SOPs, DRFs
andLogs
Pest Control
SOPs, DRFs
andLogs
Flow plans
Product,
Supply,
Staff,
Waste and
Dosposal
Cleaningand
Sterilisation
Garments,
Glassware
Access
Control,
Gowning
SOPs
Entry andExit
to
Cleanrooms
SOPs,
Posters
Equipment Production
Quality
Control
Quality
Assurance

3. Figure 3 - Focus on Equipment
The Equipment folder has been designed to hold all the documentation pertaining to the equipment in the
facility. This is visually outlined in Figure 3. Note the sub-folders and their contents. The Operation,
Maintenance and Calibration category is probably the most important as this contains the Equipment
Operating Procedures (EOPs). These will be heavily referenced throughout the system in other SOPs
requiring the use of the equipment. The LUMAC (Log of use, maintenance and cleaning) logbook system is
designed to keep track of all activities involving the operation, maintenance and cleaning of equipment.
All operation manuals, product specifications, data sheets, health and safety information for the equipment
and cleaning reagents used in their maintenance are also stored in this folder.
Documentation for GMP facility
Facility Equipment
Operation,
Maintenance and
Calibration
Equipment
Operating
Procedures
(EOPs)
Equipment Data
RecordForms
LUMAC, logs and
other DRFs.
Preparationof
Cleaning
Solutions
SOPs for cleaning
solutions
Cleaningagents
data sheets,
product infofor
cleaningagents
Equipment
monitoringand
alarms
procedures,
schedules,
parameters.
Calibration of
NIST equipment
Procedures and
Records
Operation
Manuals
Maunals, product
info etc.
Production Quality Control Quality Assurance

4. Figure 4 - Focus on Production
The production folder has been designed to hold all documentation directly pertaining to production
operations. This is visually outlined in Figure 4. Note the sub-folders and their contents. The Master
Formulae (MF) folder is probably the most important here. It contains a SOP for the writing, approval,
distribution and utilisation of the MF and Batch Processing Records as well as a template for an MF. This
has been designed so that a fresh MF plan can be set up with each new client while still using the same
template each time. This gives uniformity and flexibility to the process.
The other folders contain documents pertaining to specific sections of the production process which can be
categorised according to each individual campaign and client. The Biological Starting Materials folder is
most important here as this holds the records for all biological materials (bacteria, fungi, cells, viruses etc.)
used in production processes in the facility. This record must be well-maintained.
Documentation for GMP
facility
Facility Equipment Production
Master Formulae
SOP, Template and
guide to MF
In-Process Tests
SOPs, DRFs for
tests
Preparationof
Process Buffers and
Solutions
SOPs, DRFs for
sol. prep.
Environmental
Sampling
SOPs, DRFs, EU
guidelines
Biological Starting
Materials
SOP for regulation.
data sheets for all
bio materials.
Raw
Materials
Specifications,
Product Codes
Supplier
Approval
Receipt and
Storage
Quarantine,
Release and
Approval.
Quality Control Quality Assurance

5. Figure 5 - Focus on Quality Control
The Quality Control folder has been designed to hold all documentation pertaining to quality control
operations. This is visually illustrated in Figure 5. Note the sub-folders and their contents. The different
operations have been broken down into categories for ease of reference and filing of results. Each sub-folder
contains SOPs and DRFs for the relevant operations therein.
The Analytical Assay folder will be heavily referenced throughout the other folders in SOPs requiring the
application of such assays for the relevant tests.
Documentation for GMP facility
Facility Equipment Production QualityControl
Product
Testingand
Release
SOPs, DRFs,
QC Data
sheets
Raw Material
Testing
SOPs, DRFs,
QC Datasheets
Analytical
Assays
SOPs, DRFs
Samples - Test
andRetention
SOPs, Coded
sample log,
Summary
Protocol of QC
results
CollectedQC
Datasheets
Stability
studies
SOPs, DRFs
Reference
Standardand
Control
Maintenance
andTesting
Recertification
of QC
equipment
Calibration
records
QC reagent
andmaterial
preparation
SOPs, DRFs
Quality Assurance

6. Figure 6 - Focus on Quality Assurance
The Quality Assurance Folder has been designed to hold all documentation pertaining to Quality Assurance
and administrative operations. This is visually illustrated in Figure 6. Note the sub-folders.
The Batch record review folder contains all documents related to reviewing the production process. This
includes batch record sheets, batch approval log and SOPs for the review of a batch process. These are
essential in ensuring the product has been produced to the pre-determined specifications. Adverse events are
documented through incident reports and suitable CAPAs (corrective action, preventive action) are initiated
in response to these.
The quarantine, release, rejection and storage of product procedures are outlined in SOPs found in the same
folder for ease of reference. In the case of storage, temperature monitoring must be maintained to avoid
deviations in storage conditions. Product Distribution, Complaints and Recall procedures and records are all
documented together for ease of reference too.
All employee records are maintained in the main office. This includes both professional (CVs) and health
records with appropriate confidentiality maintained. All training received by staff as part of their
employment in the facility is documented in the training records. The responsibilities of all staff members
are also outlined in a clear and concise manner.
The Validation and Change control folder contains the Validation Master Plan, as well as protocol and
report templates for an array of qualification and validation activities. All validation in the facility is to be
documented in this folder.
The Directories and Document Control folder contains the SOP master list as well as other similar
directories for the purpose of documentation control (Equipment tracker codes, LUMAC directory,
Validation protocol/report lists etc.).
The procedure for the preparation, authorisation and distribution of SOPs is also found here.
Documentation for GMP facility
Facility Equipment Production Quality
Control
Quality
Assurance
Batch Record
Review
Batch record
sheets,
approval log,
SOP etc.
Quarantine,
Release,
Rejection,
Storage
SOPs for each
step.
Temperature
monitor
records
Product
Distribution,
Complaints,
Recall
Procedures
andRecords
Adverse
Events
Reports
Incident
reports (SOP
andDRFs)
Employee
records
professional
(CVs) and
health records.
Trainingand
Responsibility
Training
records,
responsiblity
descriptions
Validation and
Change
Control
Protocols,
Reports,
Validation
Master Plan.
Directories,
Document
control
SOP Master
list, LUMAC
list, tracker
codes, SOP
prep. etc.
Inspection
Internal,
Contractor and
Vendor Audits
Audit SOP and
records,

7. Figure 7 - Current Hierarchy in System
The current documentation system references the hierarchy illustrated in Figure 7. Note the different
positions and their titles. Responsibilities are delegated to the titles listed here and anyone employed under
these titles must take on these responsibilities.
Where an SOP refers to the “Area Manager”, it means the relevant manager to the person in question. For
example, if a production operation is to be reported to the Area Manager then the Production Manager
should be notified.
Current SOPs reference these titles when outlining responsibilities, procedures and reporting action to be
taken during operation at the facility. This hierarchy can either be altered to suit the number of personnel in
the facility or those taking on extra responsibilities can just inherit the extra title(s).
Managing Director
Quality Assurance
Manager
QA Supervisor
QA Specialist
Quality Control
Manager
QC Supervisor
QCAnalyst
Maintenance Manager
Maintenance
Supervisor
Maintenance Engineer
Production Manager
Production Supervisor
Production
Microbiologist,
Operator