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is a group of "IP CA" Laboratories Ltd. A Site Master File should be succinct and, as far as possible, not exceed approximately twenty-fiveto thirty A4 pages. The recent product quality review (PQR) of the Atazanavir Sulfate 9. SITE MASTER FILE 1.0 GENERAL INFORMATION 1.1. 1.4 The Site Master File should be a part of documentation belonging to the quality management system of the manufacturer and kept updated accordingly. The Site Master file must be updated when a major constructional upgrade takes place or when key activities and or key personnel; changes. It is based on the information as given in the PIC/S document PE 008. THE FIVE TYPES OF US FDA DMFS ARE: Introduction 1.1 The site master le (SMF) is prepared by the pharmaceutical Introduction A Site Master File (SMF) is a document that the MHRA requests the licence holder or applicant to provide, that describes the structure of the organisation involved, the site, the manufacturing activities carried out, the facility and premises employed and also details Selected Examples 30 6.1 EU: United Kingdom 30 6.1.1 . SITE MASTER FILE DOCUMENT NO. "A document prepared by the Product Manufacturer provides specific, factual information about the production and control of manufacturing operations at the site. 1.1 the site master le (smf) is prepared by the pharmaceutical manufacturer and should contain specic 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 There are several types of Master Files available from the US FDA for use in different industries such as medical, veterinary, food, and biologics. Site Master File 3 of 9 Version-01-2004--1. BRUSSELS LABORATORIES Pvt. 10, Paonta Sahib. Each chapter (1 to 9) must start on a new sheet so that updates can be provided and the relevant sheets replaced. The document is created by a manufacturer e.g., analysis, packaging 4. Ltd.is a closely held, professionally managed, WHO-GMP Certified Pharmaceutical company; manufacturing various dosages forms and located at Ahmedabad city in Changodar Ind. View pe_008_4_site_master_file_copy1.pdf from QUIMICA 1,12 at Universidad Nacional Autnoma de Mxico. 2.1 The Site Master File for Plasma warehouses (SMF - PW) refers to the PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (PI 008) and should be read in close conjunction to it; relevant terminology can be found there. Each sheet should have an edition number and an effective date. Published 6 June 2011 A Site Master File (SMF) is a document prepared by a manufacturer that provides specific, factual information about the production and control of manufacturing operations at a named site, as well as any closely integrated operations nearby buildings. The Site Master File should have an edition number and an effective date. Regular Price $280.00 Today $219.00 + 19% german VAT when applicable Add to Cart Description Table of Contents: 1. Brussels has recorded an excellent growth to reach its present standing as a growing company in the area of health care. A signed declaration regarding self-inspection 10. List of API and related manufacturing premises 8. SITE MASTER FILE v.04FEB2020 GENERAL INFORMATION 1. SMFs are internationally harmonised documents. Brief Information On The Firm Halewood Laboratories Pvt.Ltd. SITE MASTER FILE Dec. 29, 2013 31 likes 8,042 views Download Now Download to read offline Health & Medicine Technology Business Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The company has a Pharmaceuticals Formulation Plant located on a 9000 sq.Ft. GUIDELINES FOR PREPARATION OF SITE MASTER FILE This document has been prepared as a guide to assist applicants to comply with the requirements for Site Master Files with regard to all sites for pharmaceutical busi ness. It also provides information about closely integrated operations nearby . Estate area of Changodar. General information on the company and particularly, any information relevant to understand the manufacturing and/or repackaging operations 2. Site Master File or corresponding document by Blood and Tissue Establishments and manufacturers of Active Pharmaceutical Ingredients. : NIL PAGE NO: 6 OF 25 1. Site Master File 7. CONTENT OF SITE MASTER FILE Refer to Annex for the format to be used. 2.4 The Site Master File should be a part of documentation belonging to the quality management system of the manufacturer and kept updated accordingly. . The Site Master File must be submitted as loose, individually numbered A4 sheets. 4.4 ROW: Inspections, GMP, Site Master File 19 5. All updates must be submitted to the National Pharmaceutical Control Bureau (NPCB). The Site Master File should have an edition number, the date it becomes effective and the Definition, Content, Set up and Maintenance of a Site Master File 19 5.1 Definition 19 5.2 Format and Content of a Site Master File 20 5.3 Set up and maintenance of a Site Master File 21 5.4 Site Master File: a decision analysis 27 6. The document is created by a manufacturer. The SMF template includes all necessary information for the manufacturing of tablets, coated tablets, capsules, ointments, creams, gels, suppositories, suspensions, syrups, inhalers, ampoules, vials and syringes. 5. The Site Master File is a company description compiled by the drug manufacturer that contains all good manufacturing practice (GMP) aspects. A site master file or SMF is a document in the Pharmaceutical Industry which provides information about the production and control of manufacturing operations. Explanatory notes for pharmaceutical manufacturers on the preparation of a Site Master File and content of a Site Master File Draft agreed by GMP/GDP Inspectors Working Groups September 2009 Release for public consultation 15 December 2009 Deadline for comments entr-gmp@ec.europa.eu and ADM-GMDP@ema.europa.eu 31 March 2010 table of contents 1 general information on the manufacturer 1.1 contact information on the manufacturer 1.2 authorized pharmaceutical manufacturing activities of the site including those from foreign regulatory authorities 1.3 any other manufacturing activities carried out on the site 2 quality management system of the manufacturer 2.1 the Site Master File is useful to the regulatory authority in Planning and Conducting GMP audits/ inspections. The US FDA has five types of Drug Master Files which can be used for submitting information considered by the manufac- turer to be trade secret or confidential. SITE MASTER FILE Skopje, 2010 SMF - 01 Page 4 of 38 " Goce Delcev" 12; R. Makedonija 2434 Novo Selo; PHARMACEUTICAL INDUSTRY INTER - EVROGENEKS C.1.1 Brief information on the firm Inter-evrogeneks, Pharmaceutical Industry, was established on December 12, 1998, by M-r Ivan Gjorgjiev with head office located in Skopje, Nikola Vapcarov no.20/7 . CONTENT OF SITE MASTER FILES Chapter 1. The company is in Ahmedabad located (Gujarat) in India , engaged in the manufacturing Loan license & Third party for more than 23 years. The Site Master File, including appendices, should be readable when printed on A4 paper sheets. Any other manufacturing and/or repackaging activities carried out on the site 3. BENEFITS OF SMF SITE MASTER FILE (SMF) provides a general overview of the site and its operations. PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE Based on World Health Organization WHO Technical Report Series, No.961, 2011 Annex 14 WHO guidelines for drafting a site master le . General Information 1, Pharmacity, Selaqui, and Dehradun- 248011 (U.K.) which is especially allocated for pharmaceutical industries in Guideline for Preparation of Site Master File (SMF) 1.0 PURPOSE: Introduction 1.1 The site master le (SMF) is prepared by the pharmaceutical manufacturer and should contain speci c information about the quality management policies and activities of the site, the production and/or quality control of pharmaceut ical manufactur ing operat ions carr ied out at the named The Site Master File (SMF) Document shall contain specific information about the quality management policies, activities of the site, the production and/or quality control, pharmaceutical manufacturing operations, and any closely integrated operations at adjacent and nearby buildings. plot situated at Ward No. It is also a regulatory requirement. 410 1. 6. SITE MASTER FILE APPROVALS NAME SIGN REVISION NO. This Site master file is related to GPL, dedicated to manufacturing of External Preparations (Creams, Ointments, Pastes, Gels, Lotions, Solutions) and Liquid (Oral, Syrups, suspensions, mouthwashes) Preparation, located at Plot No. A Site Master File (SMF) is a document prepared by the company containing specific and factual Good Distribution Practice (GDP) information about the storage, distribution and deliveries operations carried out at the named site. Master batch manufacturing and packaging records for Atazanavir Sulfate Stage-1, Atazanavir Sulfate Stage-2 and Atazanavir Sulfate Stage-Final 11. General Information Name, address, and company description (C.1.1): Includes a brief description of the company, relation to other sites, and any information relevant to understanding the manufacturing operations. The Site Master File should have an edition number, the date it becomes effective and the date by which it has to be reviewed. Page 2 of 9 1. You can find the Explanatory Notes for the Preparation of a Site Master File(Appendix A) in Part III of the EU GMP Guideline, which was republished in December 2010. 6. 00 Production Manager Rohit Mittal EFFECTIVE DATE MAR07 Q. C. Manager Ashok Kumar PAGE . GENERAL INFORMATION: 1.1 Contact Information: 1.1.1 M/s East African (I) overseas is situated at Plot No. PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PE 008-4 1 41, KIADB Industrial Area, Malur- Kolar District 563 130 Site Master File 4.08_SMF_Jun03_v2 October 2010 Page 1 of 16 MEDICINES CONTROL COUNCIL . REVISION HISTORY Date Version Number 1 November 2002 PE 008-1 Revision of format (in line with SOP on If only part of these operations is carried out on the site, the SMF needs only to describe those SMF-01-01 EFFECTIVE DATE : DATE OF REVIEW: SUPERSEDE NO. NELSON LABS QUALITY MANUAL / SITE MASTER FILE MAN0010 ISO 17025, GLP, GMP Revision 15 Page 1 of 52 Quality Manual / Site Master File Combined document Name of the Company: Nelson Labs NV Address: Romeinse Straat 12 3001 Leuven, Belgium Phone: +32 16 400484 Fax: +32 16 401304 24h contact: Dr. Bart Boerjan (+32 472 533307) It should be subject to regular

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