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GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. Good Automated Manufacturing Practice (GAMP 5 ®) sets out principles and procedures that help ensure that pharmaceutical or medical device products have the required quality and details a recognized standard for Computer system validation (CSV).
In the pharmaceutical industry, good practices are an important way to safeguard product conformity and safety. Quality assurance is vital to ensure that the producer correctly applies good practices.
