Qualification And Validation Service
Price On Request
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.