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Guideline on process validation for finished products - information and data to be provided in regulatory submissions

We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1 
 

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About this guideline

Overseas effective date: 6 months after publication (published  27 February 2014)

Replaces: CPMP/QWP/848/96, EMEA/CVMP/598/99. Note for guidance on process validation (adopted by TGA 27 March 2002); and CPMP/QWP/2054/03, EMEA/395/03. Annex II to Note for Guidance on Process Validation. Non Standard Processes. (adopted by TGA 13 January 2005)

Categories: Quality | Manufacturing

TGA annotations:

Although the guideline refers (in Section 7: Post approval change control) to Type I and II Variations and EC Regulations, it should be noted that these legislative requirements are not applicable in Australia. Australian sponsors should refer to Australian guidance on Minor variations to registered prescription medicines: Chemical entities.

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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