VALIDATION DOCUMENTATION
Validation Documentation. The evolution of Validation required the development of suitable documents, such as the (VMP, URS, DQ, IO, OQ, P1Q, P2Q. Many manufacturing processes produce a product or part of a product that cannot be tested 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 must be in place and operational 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.
GO TO DOCUMENT STORE AND VIEW NOW BASIC VALIDATION RQUIREMENTS.
cGMP 211.100.
(1) Documented instructions, standard operating procedures (SOP's), and methods that define and control the manner of production; (2) Monitoring and control of process parameters and component and device characteristics during production; (3) Compliance with specified reference standards or codes; (4) The approval of processes and process equipment; and (5) Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples. |
