Understanding Facility Validation for GMP compliance - Indian ...

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Understanding Facility Validation for
GMP compliance
*J.Ramniwas, CEO
Sai Pharma Solutions Inc., Vadodara.
Introduction
In the past decade, many farreaching
changes have taken place in
the application of cGMP regulations
relating to the pharmaceutical industry.
Continuous quality improvement thus
is ingrained in the cGMP concept. The
design, construction, commissioning, and
validation of pharmaceutical facilities play
a very important role in the risk mitigation
of product quality and safety.
Facility qualification (a part of validation
that proves and documents that equipments
or ancillary systems are properly installed,
work correctly, and actually lead to the
expected results) and validation (establishing
documented evidence that provides a high
degree of assurance that the manufacturing
processes, including buildings, systems,
and equipment consistently produce the
desired results according to predetermined
specifications and quality attributes)
activities establish and provide documentary
evidence that the facility is suitable for the
intended use of manufacturing, testing and
storage, meeting GMP requirements.
The journey of facility validation starts
from the conceptual design in mind, then
on the piece of paper, before it takes the
concrete shape. The facility validation
protocol should cover the following
information but not limited to:
1. Purpose
2. Reason for establishing the protocol for
facility qualification
3. Protocol Approval Signatures
4. Scope
5. Validation Team and Responsibilities
Design Qualification
The premises, supporting utilities,
equipment, and processes have to
be designed in accordance with the
requirements of GMP. Design Qualification
(DQ) consists of:
1. Facility design in brief
2. Critical attributes to be met while
designing the facility
3. Location and surroundings
4. Premises
4.1 Room number
4.2 Activity to be performed
4.3 Room classification (e.g., class
100, 10,000, etc.)
4.4 Utilities required and their quality
(e.g., WFI, distilled water,
compressed air, etc.)
4.5 Room finishes (floor, walls,
ceilings, partitions)
4.6 Illumination level requirement
4.7 Safety features
4.8 Pass-through
4.9 Communicators
4.10 Prefabricated partitions
5. Paints
6. Doors and view panels
7. Electrical requirements
8. Equipments
Installation Qualification
The premises, supporting utilities, and
equipment have to be built and installed in
compliance with their design specifications.
This constitutes Installation Qualification
(IQ). Purpose of installation qualification is
to establish documented evidence that the
facility has been designed and constructed
as intended and deviations, if any, are
justified & recorded. The facility Installation
Qualification Protocol should cover the
following details but not limited to:
1. Purpose
2. Facility layout
3. Major facility verification
3.1 Facility compliance assessment for
location, surrounding and premises
3.2 Room datasheets
3.3 Verification and confirmation of
termite treatment/ pest control
certificate
4. Materials of Construction (MOC)
5. Verification of utility supply
6. Identification of facility and their status
review
7. Verification for facility installation
8. Drawings
9. Standard Operating System (SOPs)
Identification
10. Deficiency (if any) and corrective action
report
11. Justification for the changes in facility
layout
12. Deviations (if any)
13. Acceptance criteria
Operational Qualification
The facilities, supporting utilities, and
equipments operate in accordance with
their design specifications. This constitutes
Operational Qualification (OQ). Every
room/ section on each floor shall be
checked for flawless and smooth functioning
of the following as applicable. Any
discrepancy shall be identified, corrected
and documented. The facility Operational
Qualification Protocol should cover the
following details but not limited to:
1. Opening of doors
2. Closing of doors
3. Door Locks
4. Door handles and hinges
5. Door closure
6. Light sources and their fixtures
7. Illumination
8. Electrical points and their earthing
9. Water points
10. Compressed air use points
11. Air handling units/ HVAC systems
12. Temperature
13. Differential Pressure
14. Drain Points
15. Verification of Standard Operating
Procedures
16. Training Documentation
17. Acceptance Criteria
*Email id: jramniwas@saipharmasolutions.com
Pharma Times - Vol. 44 - No. 02 - February 2012 13

Performance Qualification
Performance Qualification of various
support services provided in each
room is detailed in the respective utility
protocols. The preventive maintenance
and routine cleaning and sanitization of
facility is also the part of the performance
qualification.
Requalification Criteria
1. Any change/ modification that is made
in the facility design or layout must
be requalified. The affected area
shall be requalified and the room
data sheet of the affected area shall
be updated to incorporate the change(s)
made.
2. Any change made in the existing area
support services or new or additional
features are added to the room.
Discussions and Summary
From the data compiled, a summary
report shall be prepared. Corporate technical
team shall review and approve the final
summary report prior to handling of the
building for regular use.
Attachments
The following documents should be kept
as an attachment with the facility validation
protocol and report and should be updated
with the justification of modification and
changes:
1. Approved Drawings
2. Door Specifications
3. Certificates
A specific process will consistently
produce a product meeting predetermined
specifications and quality attributes. This
constitutes Process Validation (PV) or
Process Performance Qualification (PPQ).
Facility validation covers all aspects
of product and process risk management
but after complying the facility qualification
requirements, it is mandatory to the
manufacturer to review periodically the
facility qualification status. Generally, it
has been observed that it is assumed by
pharmaceutical manufacturers that once
the facility is qualified, it will remain qualified
throughout the life cycle of his business.
But, at a particular juncture they realize
that their world class manufacturing facility
has become outdated and cannot be used
anymore for the manufacturing purpose of
medicinal products. The manufacturers of
pharmaceuticals will have to bear in mind
that what is prevalent today can become
obsolete tomorrow and we have to keep
pace with the changes taking place globally
to remain in business forever.
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Pharma Times - Vol. 44 - No. 02 - February 2012 14