Project Phase Validation4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be…
PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system…
EU Guidelines For Outsourced Activities Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed…
Change management system – Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change.…
MICROBIAL CONTAMINATION OF COMPRESSED AIR Compressed air systems can harbor the nutrients required for microbes to grow; namely water, oil,…
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…