Site Master File

• Anon
  04/03/2020 09:22

  I'm writing a Site Master File and having a debate on whether or not to reference SOPs.
• GMP Committee response
  14/05/2020 11:34

  Site Master Files do not usually reference SOPs, but instead provide high level outlines of the key Pharmaceutical Quality System processes. However, it may be useful to reference the relevant SOP for each section but this needs to be balanced with the need to have the SMF maintained and updated. The EU guidance of SMF can be found here https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2011_site_master_file_en.pdf Also you should consider any local requirements.

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