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

  • 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.

  • The aim of these Explanatory Notes is to guide the manufacturer or wholesaler of medicinal products in the preparation of a Site Master File that can be useful to the regulatory authority in planning and conducting GMP or GWP inspections as the case may be.

  • 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 Site Master File is prepared by the manufacturer and or wholesaler as the case may be and contains specific information about the quality assurance, the production and/or quality control of pharmaceutical manufacturing operations and or wholesaling operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings.

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


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

  • 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 and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • 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).

  • HEPA filter means high-efficiency particulate air filters that are rated to achieve a minimum initial particle-removal efficiency of 99.97 per cent using ASTM F 1471– 93 or equivalent standard;

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

  • CREFC® Special Servicer Property File format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • Database Management System (DBMS) A system of manual procedures and computer programs used to create, store and update the data required to provide Selective Routing and/or Automatic Location Identification for 911 systems. Day: A calendar day unless otherwise specified. Dedicated Transport: UNE transmission path between one of CenturyLink’s Wire Centers or switches and another of CenturyLink’s Wire Centers or switches within the same LATA and State that are dedicated to a particular customer or carrier. Default: A Party’s violation of any material term or condition of the Agreement, or refusal or failure in any material respect to properly perform its obligations under this Agreement, including the failure to make any undisputed payment when due. A Party shall also be deemed in Default upon such Party’s insolvency or the initiation of bankruptcy or receivership proceedings by or against the Party or the failure to obtain or maintain any certification(s) or authorization(s) from the Commission which are necessary or appropriate for a Party to exchange traffic or order any service, facility or arrangement under this Agreement, or notice from the Party that it has ceased doing business in this State or receipt of publicly available information that signifies the Party is no longer doing business in this State.

  • 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 human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Data Site means an electronic password protected data site maintained by the Borrower (or by the Collateral Manager on behalf of Borrower) at Xxxxxxx Corporation, Intralinks, SyndTrak Online or any other similar electronic distribution system reasonably acceptable to the Administrative Agent.

  • Contractor information system means an information system belonging to, or operated by or for, the Contractor.

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Death master file match means a search of the death master file that results in a match of the social security number or the name and date of birth of an insured, an annuity owner or a retained asset account holder.[PL 2017, c. 129, §1 (NEW).]

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Prescription monitoring program “PMP,” or “program” means the program established pursuant to 657—Chapter 37 for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.

  • Servicer File means, collectively, all documents, records and copies pertaining to a Mortgage Loan which are required to be included in the related Servicer File pursuant to Section 3 thereof.

  • Central fill pharmacy means a pharmacy contracting with an originating pharmacy, or having the same owner as an originating phar- macy, that provides centralized prescription filling on behalf of the originating pharmacy pursuant to these rules.

  • Data File means a single record or collection of data records that are logically related to each other, and are handled as a unit;

  • 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;

  • Web Site means the website that you are currently using (xxx.xxxxxxxxxxxxxxx.xx.xx) and any sub-domains of this site (e.g. xxxxxxxxx.xxx.xxxxxxxxxxxxxxx.xx.xx) unless expressly excluded by their own terms and conditions.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory 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: