CHAPTER 4S2 RISK BASED C&Q – PART 1
1. Outline of the execution flow of validation for the project that follows from the Lean Qualification Approach (LQA)
Based on the LQA, to prepare the whole validation document for the project provided that the main validation works here explained is only for facility and process equipment and until OQ stage (see section 3):
Site Validation Master Plan (SVMP), Computerized System Validation Master Plan (CSVMP), User Requirement Brief (URB), Good Manufacturing Practice Compliance Assessment (GMPCA), System Classification (SC), Critical Aspect (CA), Site Validation Summary Report (SVSR) Development Plan (DP), User Requirement Specification (URS), System Risk Assessment (SRA), Design Qualification (DQ), Hard/Software Design Specification (H/SDS), Installation Qualification (IQ), Operation Qualification (OQ), Traceability Matrix (TM).It should be referred from these documents as below:
User Requirement (UR) Good Manufacturing Practice (GMP) requirement Outline of Critical Quality Attribute (CQA), Critical Processing Parameters (CPP) Basic Plan/Concept Design (CD) Design Review (DR) Factory Acceptance Test/ Site Acceptance Test (FAT/SAT)
2. Validation Document Configuration under the scope of work for the project
Validation Document Configuration in the project is classified as below:
Top-level document: SVMP, CSVMP, URB, GMPCA, SC, CAR, SVSR The system without CSV or Under Category 3 includes facility (Architecture, HVAC, Utility, Water for Injection (WFI)) and process equipment (Terminal Sterilizer, Conveying, and Packing Machine): URS, SRA, DQ, FAT/SAT, IQ, OQ, and TM The system without CSV category 4 includes facility (EMS) and process equipment (Formulation machine and Form – Fill – Seal System machine): DP, CSVP, URS, SRA, DQ, H/SDS, F/SAT, STR, IQ, OQ and TM
3. Validation Document Configuration for the whole project…
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