QUALIFICATION DOCUMENTMPS#2018@RKSharma2018-07-29T23:26:49+05:30
Development of Qualification Protocols – Equipments & Computer System Validation
- Design Qualification
- Review of User Requirement Specification (URS) considering the GMP Risk Analysis
- Review of Functional Design Specification (FDS) of equipment for establishing traceability with URS and GMP Risk Analysis
- Prepare Design Qualification protocol and establish qualification for each equipment
- Co-ordinate with vendors/Prepare Factory and Site Acceptance Testing (FAT and SAT) protocols for equipment
- Co-ordinate with vendors/Prepare Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Protocols of the said equipment and systems
- Preparation/ Review of Area/ Facility Qualification Protocols
- Preparation of Analytical Method Validation/ Verification Protocols
- Preparation of Vendor Qualification Protocols for Raw & Packing Materials
- Preparation of Process Validation Protocols by considering Critical Process parameters, Critical Quality Attributes as per Process Development requirements
