Site Master File

Site Master File for Drug Products
or for APIs, DS

The Purpose of such document namely a site master file is to summarize all quality relevant information about a pharmaceutical facility. It contains a description about the layout of the site, the organizational structure, the main and most important systems and products.

When submitted to a regulatory authority, the Site Master File provides information on the manufacturer’s operations and procedures that can be useful in the efficient planning and undertaking of a GMP inspection.

A Site Master File should be succinct and, as far as possible, not exceed approximately twenty-five to thirty A4 pages.

The Site Master File should have an edition number and an effective date.

Wherever possible, simple plans, outline drawings or schematic layouts should be used instead of narrative.  These plans etc. should fit on A4 sheets of paper.

Site Master File

Following attachments should be included in the Site Master File:

  • Overview Information about the site
  • Information on the pharmaceutical site
  • Manufacturing Authorization
  • Type of actual medicinal products
  • Medicinal products marketed
  • Site Organograms
  • General building plans
  • Detailed building plans
  • Material and personnel flows
  • Most important Site SOPs
  • Process flow diagrams
  • Validated Processes
  • Manufacturing Operations
  • Out-contracted

    processes and services