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7.A Official requirements


Official requirements

Authors: Michael Hiob, Ph.D.; Max Lazar / Update 11

Here you will find answers to the following questions:

  • What are the purpose and the objective of process validation?

  • Which legal requirements have to be followed in Europe and in USA?

  • What are the expectations of the January 2011 FDA Guidance for Industry address-

ing Process Validation?

  • Which are the general principles of process validation?

  • Which requirements apply to the different types of process validation?

  • How can the validated status be maintained?

  • When and how should a revalidation be carried out?

  • Which documents have to be established for process validation?

  • How long have validation documents to be archived?


Regulative aspects

Process validation is a basic factor for drug product safety and quality and thus a fundamental component of the quality assurance system used by pharmaceutical manufacturers. It should verify that the procedures and processes used in drug and drug product manufacturing are suitable for their purposes and guarantee that the processes used to produce the drugs or drug products will consistently deliver quality products that meet their pre-determined specifications and quality characteristics.

A procedure is an established way of carrying out an activity. A process is a set of methods and actions that interact to convert inputs to outputs.


Legal requirements for drug products

The holder of a manufacturing authorization or drug application must ensure that manufacturing and analysis are carried out in line with the most recent develop- ments in science and technology. Moreover, he must also operate a quality man- agement system that includes good manufacturing practice, in line with the type and scale of the activities.

Within Europe, the EU Guidelines to Good Manufacturing Practice for Medicinal Products (see chapter C.4) must be consulted whenever the founda- tions for good manufacturing practice are laid out. This gives the EU Guidelines to Good Manufacturing Practice a high regulatory binding character. Bear in mind that methods other than those described in the EU guidelines may also be suita- ble for implementing the goals of the quality assurance principles. The EU Guidelines to Good Manufacturing Practice for Medicinal Products do not in any way intend to restrict the development of new concepts or technologies provid-

M. Hiob / M. Lazar

GMP Manual (Up11) © Maas & Peither AG – GMP Publishing



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