Monthly Archives: July 2016

For Successful Inspection……… (Part I)

Why inspection ? •      To assess & evaluate the ability of a facility to manufacture quality products which consistently meet specification and regulatory requirements. •      To confirm and assure the validity of:            Identification, traceability and integrity of lots            Manufacturing & … Continue reading

Posted in audit, Drug regulatory and guidelines | 4 Comments

GAMP 5 computer system categorization

Software Classification Categories Comparison of software categories in GAMP 4 and GAMP 5 As I mentioned earlier, the software categories in GAMP 5 have been revised. To appreciate the scope of these changes fully we need to look at the … Continue reading

Posted in Validation | 4 Comments