About GAMP 5

Good Automated Manufacturing Practice (GAMP) aims to achieve validated and compliant systems which meet regulatory requirements.

The most significant change in GAMP 5 is, if you use a risk based approach, and you have continuous on line monitoring, and have a 100% probability of detection, you do NOT need to validate the controlling PLC / SCADA package.

So, a $500, temperature strip chart recorder could offset the expense of validating the entire computerised control systems.

If you recall, validation provides a high level of assurance, not 100% assurance.

How did GAMP come about?

GAMP - The use and reliance on automated systems in pharmaceutical manufacturing had increased greatly throughout the 80s. An industry group was set up to improve and promote comprehension of the stringent regulations. The GAMP Forum was founded and is now a technical subcommittee of the International Society of Pharmaceutical Engineering (ISPE).

GAMP, version 1.0 was published in 1995, with updated versions being published in 1996, 1998 and 2001.

GAMP 5

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems was launched on 28th February 2008.

The release of GAMP 5 aims to provide guidance on regulatory compliance through cost and time effective methods and signifies a period of transition of new ideas with a more innovative approach to compliant systems.

GAMP 5 relies heavily on Risk Assessments and to put it in to context, ICH Q8, ICH Q9 and ICH Q10 as well as ASTM 2500 must be read and understood.

Still want to know more, follow this link to more about GAMP 5 Aims. or follow this link to more about GAMP 5 the future and what GAMP 5 means to us.