The acronym GAMP-5 refers to “Good Automatic Manufacturing Practices issue 5”. Although GAMP 5 has no legal standing and is purely advisory, it does contain information and methodologies that are of interest to anyone engaged in validation activities within the cGMP regulated environment.
Although Good Automated Manufacturing Practice (GAMP) is not a mandatory legislation, it provides important guidelines for companies involved in the development and/or implementation of automated systems. ,
GAMP 5® (ISPE) can be regarded as a structured approach for the validation of automated systems. Currently, version 5 of GAMP (GAMP 5 ®) has a definitive status, with no version 6 in the pipeline. Compared to previous versions, the emphasis is more on risk control and quality management.
By correctly interpreting and applying the GAMP 5® guideline, companies working in regulated industries can ensure automated systems quality. It also becomes a lot easier for them to pass audits and government inspections.
A key element of the GAMP methodology demands validation test protocols should be written at the same time the software is being coded. This is accomplished by writing highly detailed software definition documents before coding takes place.
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