Good Automated Manufacturing Practice (GAMP)

[COLOR=#000000]Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.[sup][1]

[/sup] More specifically, the ISPE’s guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality.

One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.
[COLOR=#000000]A group of pharmaceutical professionals have banded together to create the GAMP Forum, which is now a technical sub-committee, known as the GAMP COP (community of practice) of the International Society for Pharmaceutical Engineering (ISPE). The goal of the community is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry


The GAMP COP organizes discussion forums for its members. ISPE organises GAMP-related training courses and educational seminars. Several local GAMP COPs, such as GAMP Americas, GAMP Nordic, GAMP DACH (Germany, Austria, Switzerland), GAMP Francophone, GAMP Italiano, GAMP Benelux (Belgium, Netherlands, Luxembourg) and GAMP Japan bring the GAMP community closer to its members in collaboration with ISPE’s local affiliates in these regions[/color]

Since coming across this website, I have found it very relevant to my work. Thanks!

I just got introduced to CSV and our company is thinking of using the SAP software in our operations. In what GAMP classification is SAP and how do we go about the validation?

Thanks for the kind words.

That is a very loaded question indeed and I could not answer it without knowing more about how you want to use SAP.

Form experience though I would imagine that you need to do a Risk Assessment around SAP and figure out what elements will be bespoke and what elements will be COTS. I’d imagine that a large portion of the implementation will be bespoke and fall into Cat 5 of GAMP.