PROCEDURE
Prepare a Site Master File containing about 25 to 30 A4 size pages as per contents given in Annexure.Attach site plan, outline drawings or schematic layouts, pressure segregation as Annexure to the file.
Each page of SMF shall have the following header.
The Site Master File shall be prepared by ___, Reviewed By _____, Approved By Director Technical and Vice President QA.
Copies of Site Master file are issued to Sr. V.P. Technical, Director Technical and V.P. QA.
Any amendment to the Site Master File shall be done only after getting prior approval from Sr. V.P. Technical, Director Technical and V.P. QA
Copies of Site Master File can be requested from GM QA.
The SMF should contain information on the following sections
a) Contents page
b) Approval page
c) Issue details
General information
- Brief information of the firm (including name and address), relation to other sites and, particularly, any information relevant to understanding the manufacturing operations.
- Pharmaceutical manufacturing activities as licensed by the national authority including validity period.
- Any other manufacturing activities carried out on the site.
- Name and Exact Address of the Site, Including Telephone, Fax and 24 Hrs Telephone Numbers.
- Type of products manufactured on the site and information about specifically toxic, hazardous or sensitizing substances handled e.g. antibiotics, hormones, cytotoxics if any. Also, state if human and/ or veterinary products are both manufactured on the site.
- Short description of the site including the location and immediate environment, the size of the site, types of buildings, their ages.
- Brief Description of Major Production and Control Laboratory Equipment with the material of construction for product contact equipment, are the equipment designed to ease cleaning. A list of equipment is not required.
- Maintenance and servicing of equipment of production and utility.
- Describe the Qualification, Validation and Calibration activities including the Company's general policy, and protocols for qualification, prospective and retrospective validation.
- Sanitation procedure: Availability of written specifications and procedures for cleaning manufacturing areas and equipment.
Documentation
- Preparation, revision and distribution of documentation for manufacture. Describe the documentation system, responsibilities, storage of master documents, instructions for preparation of documents, procedure for control of documents, retention time.
- Any other documentation related to product quality. Describe other documents available which are not mentioned elsewhere including the Equipment specifications, Specifications for disposables i.e. cleaning materials, Standard operating procedures.
Production
- A brief description of production operations. Describe the operations capable of being carried out at the site with the existing facilities using flow sheets and charts specifying important parameters. Technical details are not required.
- Arrangements for the handling of rejected materials and products.
- Describe the labeling, storage, disposal and destruction of rejected material and products.
- Policy for process validation
- Provide a brief outline of process validation protocol.
Quality Control
Description of the Quality Control system and of the activities of the Quality Control Department. Procedures for the release of finished products.Contract manufacture and analysis
Description the way in which the GMP compliance of the contract acceptor is assessed.Distribution, complaints and products recall
- Arrangements and recording system for distribution.
- Provide a brief description of Storage and Distribution Practices, conditions of storage in warehouse.
- Records and DistributionDo the retained records permit full batch traceability from the factory to the customer, in terms of the date of sale, customer details and quantity despatched?
- Handling of complaints
- Define responsibilities for Logging, Classifying, and Investigation of complaints. Reports prepared, review, retention time of records.
- Product recalls
- Describe responsibility for product recalls, the sequence of actions for Retrieval of distribution data, Notification to customers, Receipt/segregation/inspection of returned product, Investigation/reporting of cause, Reporting corrective action.
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