Site Master File definition

Site Master File means a document prepared by the manufacturer containing specific and factual good manufacturing practice information about the production and/or control of pharmaceutical manufacturing operations carried out at a named site and any closely integrated operations at adjacent and nearby buildings;
View Source
Site Master File means a document prepared by GenIbet containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the Facility and any closely integrated operations at adjacent and nearby buildings.
View Source
Site Master File means a document prepared by the wholesaler or distributor
View Source

Examples of Site Master File in a sentence

  • A "full inspection report" comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.

  • A ‘full inspection report’ comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.

  • A ‘full inspection report’ comprises a Site Master File (compiled by the manu­ facturer or by the inspectorate) and a narrative report by the inspectorate.

  • A “full inspection report” comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.

  • BI shall provide BioCancell and its designee with a letter of authorization, in a form acceptable to BioCancell, permitting BioCancell, its designees, the FDA and other regulatory authorities to review and make reference to the Site Master File and/or Drug Master File (Type V) of BI.

  • In accordance with the Product Master Plan, ▇▇▇▇▇▇ shall file and maintain the appropriate Drug Master File ("DMF") and related reference applications (e.g. Site Master File) for its Production of each Product hereunder in accordance with 21 CFR 314.420, as may be amended from time to time, at ▇▇▇▇▇▇'▇ expense.

  • A ''full inspection report'' comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.

  • Patheon shall provide the Manufacturing License(s), GMP Certificate(s), and the Site Master File to Synageva for submission of any regulatory dossier.

  • BI Austria shall file and maintain for its facility in Austria a Site Master File and a Drug Master File which will be provided or made available to the HEALTH AUTHORITIES whenever requested.

  • The Requester will submit a Site Master File on the Foreign Site to Health Canada no later than 30 days prior to:   (schedule inspection date).


More Definitions of Site Master File

Site Master File means a document containing specific information about the activities undertaken in the pharmaceutical manufacturing site and is usually prepared by the manufacturer.
View Source
Site Master File means the documentation required as part of the licensing procedures (market authorization) by any Regulatory Body having jurisdiction over such licensing, for the Plasma-Derived Products, including, without limitation, details of the manufacturing building, location, construction, service facilities and environment, which is kept in an independent file;
View Source
Site Master File means a document that contains specific information about the quality assurance, the production and/or quality control of pharmaceutical manufacturing operations carried out at the Foreign Site and any closely integrated operations at adjacent and nearby buildings. The guidance document entitled « Explanatory Notes for Industry on the Preparation of a Site Master File » (▇▇▇▇://▇▇▇.▇▇- ▇▇.▇▇.▇▇/▇▇▇-▇▇▇/▇▇▇▇▇▇-▇▇▇▇▇▇▇/▇▇▇▇▇▇▇▇/▇▇▇▇▇▇▇▇▇▇/▇▇▇_▇▇▇▇_▇▇-▇▇-▇▇▇.▇▇▇) may be consulted for further guidance.
View Source
Site Master File means a document prepared by a manufacturer which provides information about the production and control of manufacturing operations
View Source

Related to Site Master File

  • Master File has the meaning set forth in the CAISO Tariff.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Death master file means the United States social security administration’s death master file or any other database or service that is at least as comprehensive as the United States social security administration’s death master file for determining that a person has died.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).