A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information…
Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). The Site Master File…
The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after…
Annual Product Review (APR) is the requirement of various regulatory agencies. APR roots the monitoring of product quality as well…
Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing…
Standard Operating Procedure (SOP) for Operation and Cleaning of Metal Detector and Combo Metal Detector cum Deduster used during the…
Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first…
Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Control, Microbiology, Utility, Stores, etc…
At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation…