SITE MASTER FILE

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SITE MASTER FILE VIJAY BELWAL M.PHARMA (PHARMACEUTICS)

Site Master File:

Site Master File Is a document, which gives a complete information regarding a site of pharmaceutical plant. The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management. 1-GENERAL INFORMATION Brief information on the firm :-including Name, Address, Licensed activities, Employees, Quality Management system etc . Contact information of the manufacturer including 24 hrs telephone number of the contact personnel in the case of product defects or recalls.

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Number of employees and workers engaged in: Production Quality control Storage Other (e.g., security) Distribution Brief description of the quality policy of the company (with reference to the Quality Manual). Responsibilities of the QM Head of QM QA manager QC manager

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2-Personnel's Organization Chart, Key Personnel, Training, Health requirement etc. Organization chart :- the arrangements for : Quality assurance, Production and Quality control. are showing In this figure

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key personnel:- Qualifications, experience, & responsibilities Head of Production Head of QM Authorized person Persons with delegated functions (but not responsibilities) Arrangements for Basic and In-service Training and how Records are maintained Health Requirements for Personnel Engaged in Production

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3- Premises and Equipments:- Plan of Facility, Nature of Construction / Finishes, HVAC, Water Systems, Preventive Maintenance of Premises & Equipments, Type of Equipments, Validations, Qualifications, Calibrations and Cleaning etc. Premises:- Short description of plant description of manufacturing areas with indication of scale (architectural or engineering drawings are not required) Lay outs and flow charts of the production areas (i.e. compounding, filling, storage, packaging, etc.) Lay-outs of warehouses and storage areas

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Special areas for the handling of : toxic hazardous & sensitizing materials. Brief description of specific storage conditions. Brief description of heating, ventilation and air conditioning (HVAC) systems Brief description of other relevant utilities such as : steam, compressed air, nitrogen, etc.

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Equipment:- Brief description of major equipment used in production and control laboratories Major pieces of equipment used in: Capsule plant Tablet plant Packing plant QC laboratory Qualification and calibration, including the recording system. Arrangements for computerized systems validation. Refer to the Validation Master Plan (VMP) and outline qualification, calibration and revalidation as well as cleaning validation schedules/annual plans.

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4-DOCUMENTATION:- Arrangements for the- preparation, revision, and distribution Batch manufacturing and quality records are controlled documents design ( title, number, version, date, signature, etc.), preparation, review, approval, reproduction, entry of data and information, storage, destruction, and so on). Validation protocols, records, job descriptions, contracts with suppliers and customers, etc. (directly related to product and process quality).

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5- Production Type of products: included list of dosage forms of both human and veterinary products. Process validation - Brief description of general policy for process validation. 6-Quality control Description of the quality control system and of the activities of the quality control department. Procedures for the release of finished products.

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7- Distribution, complaints, and product recall Distribution Arrangements and recording system for distribution. The distribution records are readily available to the Authorized Person, and they contain sufficient information on wholesalers and directly supplied customers. Arrangements for the handling of complaints and product recalls 8-Self-inspection Short description Written instructions for self-inspection. Self-inspections are conducted every six (6) months.

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THANKU

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