Operation cum performance qualification protocol cum report shall consist of minimum contents,but not limited to.
TITLE
Pre Approval
Overview
- Purpose
- Background
- Responsibility
- Requalification
- System Description
FBD Machine
Operational Qualification Procedure
- Training Date
- Calibration Review
- Key Functionality
- Safety Features
- SOP verification
- Preventive maintenance procedure verification
- Operational testing
- Performance Qualification Results
- Deficiency (if any) and Corrective Action Report
Acceptance criteria
Summary
Post Approval
Appendix
7.1 Abbreviations
7.2 List of Documents
What happens if you take expired Medicines?
Appendix: Under this section mention the abbreviation and list of the document.
Post approval signatures: after the operation cum performance qualification all the data is reviewed by the head of the engineering, production, and quality head and take the certification of its approval.
Conclusion: this section gives the result of all the qualification activity and data that should be mentioned that it undergoes for operational use.
Summary: This section summarized all the operation cum performance qualification activities.
Acceptance criteria: under this section check the acceptance criteria for performance qualification.
Deficiency (if any) and corrective action report: Under this section the Deficiency if any shall be reported.
Operation Qualification procedure: Under this section training, Calibration Review, the key functionality of equipment, safety features, and SOP verification. operational testing and performance qualification test at three runs shall be mentioned.
Overview: under this section purpose, background about the operational performance qualification responsibility, requalification, and system description is come.
