V – Model Concept:
The approach for qualification / validation is adopted from the V-Model concept. This approach is based on the philosophy that validation begins at the conceptual stage of a project and continues throughout the life cycle of the system. The process begins by need identification in the form of URS, followed by functional specification and Design specification and their relevance with various stages of validation as illustrated below:
Qualification / Validation contains the following phases
1. User Requirement Specification (URS),
2. Function Specification (FS) / Function Design Specification (FDS) ,
3. Design Specification (DS) / Design Qualification (DQ),
4. Installation Qualification (IQ),
5. Operational Qualification (OQ) &
6. Performance Qualification (PQ).
User Requirement Specification (URS)): is a document that describes the intended use along with requirements & acceptance criteria considering basic functional and design aspects from which detailed functional & design specifications can be drawn.
URS is linked to Performance Qualification, which tests the system in its operating environment with the product.
Commissioning is the process of ensuring that all business critical and GMP building utilities, equipment and process equipment are designed, installed, functionally tested, and capable of operation in conformance with design intent. Commissioning activities will be directed by Technical Background Document with a level of oversight applied by the site Quality Assurance and Facilities Engineering.
Functional Specification (FS) / Functional Design Specification (FDS) is a document that describes the detailed functional attributes along with necessary safety features wherever applicable.
FS is linked to Operational Qualification, which tests all functions specified as per the requirements / defined in the FS without product.
Design Specification (DS) / Design Qualification (DQ) is a document that describes the design aspects in sufficient detail to enable it to be constructed, installed and qualified.
DS is linked to Installation Qualification, which checks that the correctness of supply and the installation.
Installation Qualification (IQ) verifies and documents evidence that all key aspects of installation meet the approved design specifications as intended and that the installation recommendations derived from in-house / manufacturer / supplier, have been suitably achieved.
Operational Qualification (OQ) verifies and documents that the installed equipment / system operates within typical or anticipated operating ranges indicated in the Functional specification without actual product.
Performance Qualification (PQ) verifies and documents evidence that the system in its normal operating conditions performs as intended with placebo (OSD) throughout anticipated operating ranges.
Process Validation (PV) verifies and documents evidence that the process in its normal operating conditions performs as intended and produces product complying to pre-determined specification and quality parameters consistently.
Complete Validation will be provided for all oral Equipments as per validation concepts:
1) Coating machine,
2) Compression machine,
3) Fluid bed Dryer &FBC
4) RMG, Blender,
5) Sifter and Multimill etc.
3) Complete Validation will be provided for all Injection Equipments as per validation concepts: –
1) Tunnel,
2) DHS,
3) Autoclave,
4) Filling machines,
5) Lyophilizer,
6) Washing machine,
7) Isolators,
8) Lyophilizer
Complete Validation will be provided for all Primaries &secondary packing equipments as per validation concepts: –
1) Blister packing machine
2) Strip packing machine
Utilities Qualification
The following GMP utilities supply services needed for operation of the facility and equipment. These utilities have either direct contact with the product or forms as components for the product.
1. HVAC system
2. Purified water system
3. Water for Injection System
4. Compressed air system and other gases
5. Pure Steam generation and distribution system
Other Utilities which are listed below shall be commissioned as per GEP as they do not have direct impact on the product quality.
a) Chilled water generation and distribution system
b) Hot water generation and distribution system
c) Potable water distribution
d) Electrical distribution system
e) Raw Steam Generation & Distribution System
f) Drainage system
