Performance qualification protocol cum report shall consist of minimum contents but not be limited to
TITLE
Pre Approval
Overview
- Purpose
- Background
- Responsibility
- Requalification
- System Description
Performance Qualification Procedure
- Training Date
- Performance Qualification Results for Run-1
- Performance Qualification Results for Run -2
- Performance Qualification Results for Run-2
- Deficiency (if any) and Corrective Action Report
Acceptance criteria
Summary
Post Approval
Appendix
7.1 Abbreviations
7.2 List of Documents
LINE CLEARANCE CHECKLIST FOR DISPENSING AREA
For performance Protocol cum report writing with respect to activity
Pre Approval: It is described above.
Overview: under this section purpose, background about the operational performance qualification responsibility, requalification, and system description is come.
Performance Qualification procedure: Under this section of training, a performance qualification test at three runs shall be mentioned.
Deficiency (if any) and corrective action report: Under this section the Deficiency if any shall be reported.
Acceptance criteria: under this section check the acceptance criteria for performance qualification.
Summary: Under this section summarized all the performance qualification activities.
Conclusion: this section gives the result of all the qualification activity and data that should be mentioned that it undergoes for operational use.
Post approval signatures: after the Performance qualification, all the data is reviewed by the head of the engineering, production, and quality head and take the certification of its approval.
Appendix: Under this section mention the abbreviation and list of the document
