A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information…
The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after…
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 Handling Power Failure situations in different areas like Production, Quality Control, Microbiology, Utility, Stores, etc…
Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply…
At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation…
CAPA (Corrective Action & Preventive Action) is an area that we talk about often, mainly because it’s still such a…
The laboratory or Quality organization management should establish, implement and maintain a quality management system appropriate to the scope of…
Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the…