A Project Validation Plan (PVP) for Quality Control (QC) facilities outlines the structured approach to ensure that the QC facilities comply with regulatory standards, operate as intended, and meet the requirements for testing pharmaceutical products.
- Project Validation Plan for QC facilities
- Air Dryer
- Bin Wash Station
- Bio Safety Cabinet
- Cooling Chamber
- Dispensing Booth
- Dynamic Pass Box
- Incubator
- Laminar Air Flow
- Sampling Booth
- Stability Chamber
- Steam Heat Sterilizer
- Vertical Autoclave
A Project Validation Plan (PVP) for Quality Control (QC) facilities is the master, project-level document that defines what will be qualified/validated, how, by whom, and with what acceptance criteria before a QC lab is released for GMP testing. It aligns with the Pharmaceutical Quality System and Quality Risk Management so validation effort is proportional to risk.
1) Purpose and scope
Define the facility boundary and intended use: chemical lab, microbiology/sterility, stability chambers, sampling rooms, reagent rooms, glassware wash, media prep, LAF/BSC, cold rooms, archives, and IT/data systems. State applicable standards (GMP, GDP/ALCOA+, data integrity, EHS).
2) Validation strategy (risk-based)
Include a risk assessment (e.g., impact on data integrity, contamination control, and patient risk) to classify systems as direct/indirect/no impact. Specify lifecycle approach: URS → DQ → IQ/OQ/PQ, with rationale for grouping systems into packages.
3) Facility and utilities qualification
List critical utilities with acceptance criteria and test references:
- HVAC: air changes, pressure differentials, temperature/RH mapping, HEPA integrity (where applicable), recovery tests.
- Water systems (PW/WFI if used in QC), compressed air, gases (N₂, CO₂), vacuum.
- Electrical (UPS for instruments, emergency power), lighting (lux), noise, vibrations (instrument-sensitive areas).
- Environmental monitoring plan for microbiology zones and controlled areas.
4) Equipment and instrument qualification
Define inventory, impact assessment, and qualification route for HPLC/GC/UV, balances, dissolution, TOC, incubators, autoclaves, pH meters, stability chambers, refrigerators/freezers, pipettes, BSC/LAF, and washer/dryers. Include calibration and maintenance programme and reference to SOPs.
5) Computerized systems & data integrity
Identify LIMS, CDS (Chromatography Data System), instrument software, audit trails, user access roles, backup/restore, time sync, and validation approach (CSV): intended use, configuration control, and periodic review.
6) Documentation and deliverables
Provide a validation matrix and schedule; protocols and reports (DQ/IQ/OQ/PQ), deviation handling, traceability matrix, controlled drawings, commissioning records leveraged where justified, and training records.
7) Change control and release
Define how changes are assessed during execution, how deviations are closed (CAPA), and the final Validation Summary Report criteria for QC facility release for routine GMP testing.