The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site, and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master File need only describe those operations, e.g. analysis, packaging, etc.
The aim of these Explanatory Notes is to guide the manufacturer of medicinal products in the preparation of a Site Master File that is useful to the regulatory authority in planning and conducting GMP inspections.
It applies to all materials of ruminant origin that are used in the preparation of both active (e.g. sheep placenta) and inactive ingredients (e.g. gelatin), and any other reagent that may come into contact with these products during their manufacturing process (e.g. enzymes). For human blood-derived ingredients.
The risk of transmission of infectious agents can be greatly reduced, by controlling a number of parameters. These parameters include the source of animals, the nature of animal tissue used in manufacturing, and the production process.
This guideline is to help sponsors and investigators overcome the challenges in IP management, without compromising the principles of Good Clinical Practice (GCP).
This guidance applies to clinical trials where:
(a) a Clinical Trial Certificate (CTC), Clinical Trial Authorisation (CTA) or Acceptance of Clinical Trial Notification (CTN) has been issued by HSA;
(b) the investigational product is a locally registered medicinal product or locally registered therapeutic product; and
(c) the hospital pharmacy is used for IP management.
GCP Inspections may either be protocol-specific or systems. Examples of clinical trial systems that may be inspected include informed consent, investigational products, pharmacovigilance, biological samples, monitoring, etc.