GAMP – Good Automated Manufacturing Practice

Good Automated Manufacturing Practice (GAMP) is a recognised code of practice in pharmaceutical industry; however, it is not legally binding. Nevertheless, GAMP became a standard body of rules for validation of computer-supported systems in the pharmaceutical industry.

Under the impression of increasingly complex computer-supported systems and their growing implementation in the GMP-relevant areas such as quality control laboratories and document administration, the authorities pay special attention to the associated validation activities. In view of the revision of Annex 22 of the EU GMP Guide and the introduction of the CFR Part 11 in the USA, we therefore offer our clients GAMP audits. This will allow you to keep track of the important aspect of Good Automated Manufacturing Practice of your suppliers.