Validating chromatographic

A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation.Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification.Qualification includes the following steps: There are instances when it is more expedient and efficient to transfer some tests or inspections from the IQ to the OQ, or from the OQ to the PQ.This is allowed for in the regulations, provided that a clear and approved justification is documented in the Validation Plan (VP).The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan.These documents, terms and references for the protocol authors are for use in setting the scope of their protocols.In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011).

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The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract Here, the software for a large radiotherapy device was poorly designed and tested.In 1983 the FDA published a guide to the inspection of Computerized Systems in Pharmaceutical Processing, also known as the 'bluebook'.Recently both the American FDA and the UK Medicines and Healthcare products Regulatory Agency have added sections to the regulations specifically for the use of computer systems.This combined testing of OQ and PQ phases is sanctioned by the European Commission Enterprise Directorate-General within ‘Annex 15 to the EU Guide to Good Manufacturing Practice guide’ (2001, p.6) which states that: This requirement has naturally expanded to encompass computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials.

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