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;
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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.
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Site Master File means a document prepared by the wholesaler or distributor
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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 list identifying the subjects by subject number will be kept in the Site Master File.

  • 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 list identifying the subjects by subject number and Screening number will be kept in the Site Master File.

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

  • These Explanatory Notes apply to the preparation of the Site Master File.

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

  • REQUIRED GMP DOCUMENTATION (BY TYPE) Site Master File: A document describing the GMP related activities of the manufacturer.

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

  • Written procedures should be in place for the preparation, review and update of the Site Master File.


More Definitions of Site Master File

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 » (xxxx://xxx.xx- xx.xx.xx/xxx-xxx/xxxxxx-xxxxxxx/xxxxxxxx/xxxxxxxxxx/xxx_0000_xx-xx-xxx.xxx) may be consulted for further guidance.
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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 Proteins, the Additional Proteins and the Products, including, without limitation, details of the manufacturing building, location, construction, service facilities and environment, which is kept in an independent file;
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Site Master File means a document prepared by a manufacturer which provides information about the production and control of manufacturing operations
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Related to Site Master File

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • HEPA filter means a high efficiency particulate absolute air filter capable of trapping and retaining 99.97 percent of fibers greater than 0.3 micrometers in mass median aerodynamic diameter equivalent.

  • Central Contractor Registration (CCR) database means the primary Government repository for Contractor information required for the conduct of business with the Government.

  • Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Prescription monitoring program means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

  • health and safety file means a file, or other record containing the information in writing required by these Regulations "health and safety plan" means a site, activity or project specific documented plan in accordance with the client's health and safety specification;

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following: