Qualification and Validation

Qualification and Validation

We help the clients in ensuring their manufacturing facilities (a) the pharmaceutical products manufacturing and supporting equipment, facilities, systems/ controls, processes and methods are qualified & validated to suit their intended purpose, and are aligned with a product lifecycle concept and with current guidance(s) which is a mandatory GMP compliance requirement.

Development

Qualification Policies & Strategy, Validation Master Plan, Qualification & Validation Protocols & Reports, for Non Sterile and Sterile formulations including , 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, Trend Analysis, Statistical Process Performance/Capability Analysis, Annual Product Reviews. Etc.

Guidance & Training

We guide and train the staff to conduct an effective Qualification & Validation process in order to minimise/ eliminate the loss of time and money,

Investigations

Failures Investigation, Guidance, Reporting, Review and CAPA (product testing, stability, environmental monitoring, market complaints, etc.) and Position Papers