GMP audit is a process by which an external or internal individual or team verifies that a manufacturer is following its documented Good Manufacturing Practices. GMP audit of any pharmaceutical industry is very critical and important in the terms of its business. Therefore, the preparations for the audit ...

GMP audit of any pharmaceutical industry is very important and crucial in its business. Therefore, before the audit, the preparation of the audit must be done properly. We can plan any GMP audit in the following ways: 1. Documents reviewed: A list of all documents related to the audit should be prepared. ...

1 Site Master File. 2 Air Quality Manuals. 3 Water Quality Manual. 4 All process-related SOPs. 5 Standard Testing Procedures (STPs) and Specifications for Raw Material, Packing Material, Intermediate, and Finished Product. 6 Market Complaints Record. 7 Calibration Record. 8 Process Validations report ...

GMP audit of any pharmaceutical industry is very important and crucial in its business. Therefore, before the audit, the preparation of the audit must be done properly. We can plan any GMP audit in following way: 1. Review documents 2. Prepare audit plan 3. Key persons 4. Audit responsibilities 5. Internal ...

GMP audit of any pharmaceutical industry is very important and crucial in its business. Therefore, before the audit, the preparation of the audit must be done properly. We can plan any GMP audit in the following ways: 1. Documents reviewed: A list of all documents related to the audit should be prepared. ...