Compliant Documentation.

In the qualification of equipment and processes, precise and properly scoped documentation is mandatory. Validation Documentation, such as, (URS, DQ,  IO, OQ, P1Q, P2Q
However, there are many manufacturing processes that produce a product or part of a product that cannot be tested (Compliant Documentation.) without damaging it, or indeed destroying it.  The introduction of QA allowed manufacturers to build and destructively test, then using rigorously enforced quality controls replicate the tested product exactly, now knowing its performance and limitations.  Pharmaceutical, biopharm and medical device companies must demonstrate to the regulators that their whole operation is under similar control.  Quality Control that will ensure all operations are documented, all materials are verified as correct and all equipment is qualified as fit for purpose.   All this Compliant Documentation must be in place and in operational use, prior to receiving regulatory approval to manufacture.  This status must be maintained to a standard that ensures consistent replication of all the production processes and without ever compromising the quality of that product.  The maintenance of these standards is called ‘continued Good Manufacturing Practices’ (cGMP).  This qualified or approved state is subject to continuous ministering and inspection by the regulatory authorities involved, as long as the product is in production.