Qualification and Validation
- Development – Qualification Policies & Strategy, Validation Master Plan, Qualification & Validation Protocols & Reports, Sterility Assurance Plans, Cleaning Validation, Computer System Validation, Process Validation, Sterilization/ Bio-decontamination (VHP) Process, Media Fill/Process Simulation Test, Analytical Methods (Chemistry & Microbiology).
- Reviews and Gap Analysis – Regulatory Compliance, Suitability & Adequacy, Sterility Assurance, Media Fills/Process Simulation Test, Trend Analysis, Statistical Process Performance/Capability Analysis, Annual Product Reviews.
- Guidance & Training – Qualification & Validation, Sterility Assurance, Media Fills, Aseptic Manufacturing
- Investigations – Failures Investigation, Guidance, Reporting, Review and CAPA (product testing, stability, environmental monitoring, market complaints, sterility, media fill etc.) and Position Papers
- Execution – Coming soon
Ensuring that; (a) the pharmaceutical products manufacturing and supporting equipment, facilities, systems/ controls, processes and methods are qualified & validated to suit their intended purpose, and (b) the qualification & process validation activities are aligned with a product lifecycle concept and with current guidance(s) is an important and mandatory GMP compliance requirement.
The drug regulatory agencies expect the pharmaceutical product manufacturer to use modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.