New Annex 2 to Note for Guidance on Process Validation

GMP News No. 454

24 August 2004

New Annex 2 to Notefor Guidance on Process Validation

On 10 August 2004, EMEA published Annex 2 to the Note for Guidance onProcess Validation. This annex is planned to come into force in January2005.

The new annex, which comprises not more than 3 pages, can only be readtogether with the main document, the Note for Guidance on Process Validation (CPMP/QWP/848/96or EMEA/CVPM/598/99), which came into operation in September 2001. TheNote for Guidance had been created in order to define in which casesinformation on process validation has to be handed in together with thedossier for a marketing authorisation. Apart from that, it specifies therange of data that have to be provided. Both the relevant directives (Annex Ito Directive 2003/63/EC and Directive 2001/82/EC) and the above-mentioned Note for Guidance on Process Validationrefer to "non-standard methods of manufacture." The new Annex 2now regulates the validation of non-standard processes and defines whichprocesses are to be subsumed under the term "non-standard methods ofmanufacture."

In the definition of "non-standard processes" the text givesexamples where "production scale validationdata" have to be handed in as early as during marketing authorisationor - as the original text states not quite clearly - "might need tobe provided" during this phase.

When looking at these examples, one is surprised how many processes areconsidered to be non-standard. On the whole, 4 criteria are mentioned:

  • The manufacture of specialised pharmaceutical dose form
  • The incorporation of some new technology into a conventional process
  • (Highly) Specialised processes involving new technologies or anestablished process known, or likely, to be complex and therefore torequire particular care
  • Non-standard methods of sterilisation

Annex 2 gives lyophilisation as an example for item 3 and asepticprocessing as well as parametric release for item 4. Also the furtherpoints mentioned in the text lead to the fact that a number of methods areclassified as "non-standard processes" and therefore productionscale validation data have to be provided at the time of submission. 

You can download Annex 2 to the Note for Guidance on Process Validation ifyou click here.

Please click hereif you would like to download the main document of 1 March 2001.

Oliver Schmidt
Dr Günter Brendelberger

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