Tuesday, July 12, 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 & packaging procedures
            Analytical methods
      Confirm that the procedures, processes and methods described in registered dossiers (BLA, NDA, ANDA…) and/or modifications and updates are consistently applied.
      Follow-up in response to a specific issue (recall).

Thursday, July 7, 2016

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 classification of software from GAMP 4 and compare this with GAMP 5.
In the beginning, or at least in GAMP 4, there were five categories of software:

Category 1: Operating systems
Category 2: Firmware
Category 3: Standard software
Category 4: Configured software
Category 5: Custom software

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