1.0 OBJECTIVE
To lay down a procedure for Site Master File.
2.0 SCOPE
This procedure is applicable for site master file preparation at company Name.
3.0 RESPONSIBILITY
3.1 Preparation: Head-Quality Assurance
3.2 Review: Head-Quality Control and Head-Production
3.3 Authorization: Managing Director.
4.0 PROCEDURE
4.1 Prepare a Site Master File in A4 size pages.
4.2 Each page of SMF shall have the following header. Title of the Document, document number, Page XX of YY, revision No, Effective Date and Review Date.
4.3 The Footer of the First page Consists of Signatures of Prepared by (Head, Quality Assurance), Checked by (Head- Quality Control, Head- Production) and Authorized by (Managing Director).
4.4 Any amendment to the Site Master File shall be done only after getting prior approval from Managing Director through Change Control Form.
4.5 General information
4.5.1 Brief information of the firm (including name and address), relation to other sites and, particularly, any information relevant to understanding the manufacturing operations.
4.5.2 Pharmaceutical manufacturing activities as licensed by the national authority including validity period.
4.5.3 Short description of activates at the manufacturing site.
4.5.4 Any other manufacturing activities carried out on the site.
4.5.5 Name and Exact Address of the Site, Including Telephone, Fax and 24 Hrs Telephone Numbers.
4.5.6 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.
4.5.7 Short description of the site including the location and immediate environment, the size of the site, types of buildings, their ages.
4.5.8 No of employees in various departments present in the manufacturing facility.
4.5.9 Write if there is any outside analytical Assistance is taken to perform the analysis of the materials used in the production.
4.6 Quality Management System
4.6.1.1 Quality Management System
4.6.1.1.1 Brief description of the quality management systems run by the company and reference to the standards used
4.6.1.1.2 Responsibilities related to the maintaining of quality system including senior management
4.6.1.1.3 Information of activities for which the site is accredited and certified, including dates and contents of accreditations, names of accrediting bodies.
4.6.1.2 Release procedure of finished products
4.6.1.2.1 Detailed description of qualification requirements (education and work experience) of the Authorised Person(s) / Qualified Person(s) responsible for batch certification and releasing procedures;
4.6.1.2.2 General description of batch certification and releasing procedure.
4.6.1.3 Management of Suppliers and Contractors
4.6.1.3.1 A brief summary of vendor development Program.
4.6.1.4 Quality Risk management
4.6.1.4.1 Brief description of QRM methodologies used by the manufacturer.
4.6.1.5 Product Quality Review
4.6.1.5.1 Brief description of methodologies used
4.7 Personnel
4.7.1 Write the Organization chart and identify the various departments present in the Manufacturing facility.
4.7.2 Tabulate the Qualifications, experience and responsibilities for staff present in the organization.
4.7.3 Describe the Qualification and experience of key personnel present in the organization.
4.7.4 Briefly describe the procedure for Training of personnel who is newly inducted.
4.7.5 Describe the health requirements of personnel present in the organization.
4.7.6 Briefly summarize the measures taken by the organization with respect to Personnel safety and hygiene.
4.8 Premises and Equipment
4.8.1 Premises
4.8.1.1 Briefly summarize the description of manufacturing area
4.8.1.2 Narrate the Nature of construction and type of materials used in the construction.
4.8.2 Brief description of Air handling systems
4.8.2.1 Principles of defining air supply, temperature, humidity, pressure differentials and air change rates, policy of air circulation(%).
4.8.3 Procedure for handling the Handling of toxic materials
4.8.3.1 Briefly summarize the procedure for handling the Handling of toxic materials
4.8.4 Brief Description of Water Systems
4.8.4.1 Quality references of water produced and schematic drawings of the systems.
4.8.5 Brief description of other relevant utilities, such as steam, compressed air, nitrogen, etc.
4.8.6 Description of planned preventive maintenance programs for Premises and of recording System.
4.8.7 Equipment
4.8.7.1 Brief Description of Major Production and Control Laboratory Equipment with material of construction for product contact equipment surfaces. Are the equipment designed to ease cleaning? A list of equipment shall be enclosed.
4.8.7.2 Description of planned preventive maintenance programs for equipment and recording systems.
4.8.7.3 Describe the Qualification, Validation and Calibration activities including the recording systems and arrangements for computer system validation.
4.8.8 Cleaning & Sanitation
4.8.8.1 Availability of written specifications and procedures for cleaning manufacturing areas and equipment.
4.9 Documentation
4.9.1 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 and retention time.
4.9.2 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.
4.10 Production
4.10.1 Type of Products
4.10.1.1 Describe the Production 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.
4.10.1.2 Description for arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage;
4.10.1.3 Arrangements for the handling of Approved materials and rejected materials and products.
4.10.1.4 Process Validation
4.10.1.4.1 Brief describe general policy for process validation.
4.10.1.5 Material Management and Warehousing
4.10.1.5.1 Describe the arrangements for the handling of starting materials, packaging materials, bulk and finished products including sampling, quarantine, release and storage.
4.10.2 Brief description of arrangements for the handling of rejected materials and products
4.11 Quality Control
4.11.1 Description of the Quality Control system and of the activities of the Quality Control Department. Procedures for the release of finished products.
4.12 Loan license manufacture and licensee
4.12.1 Description of way in which the good manufacturing practices compliance of the contract acceptor is assessed.
4.13 Distribution, Complaints, product defects and Products Recall
4.13.1 Provide a brief description of Storage and Distribution Practices, conditions of storage in warehouse.
4.13.1.1 Records and Distribution
4.13.1.1.1 Do 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?
4.13.1.2 Handling of complaints
4.13.1.2.1 Define responsibilities for Logging, Classifying, and Investigation of complaints. Reports prepared, review, retention time of records.
4.13.1.3 Product recalls
4.13.1.3.1 Describe responsibility for product recalls, sequence of actions for Retrieval of distribution data, Notification to customers, Receipt/ segregation/ inspection of returned product, Investigation/reporting of cause, report corrective action.
4.14 Self-Inspection
4.14.1 Short description of the self-inspection program with focus on criteria used for selection of the areas to be covered during planned inspections, practical arrangements and follow-up activities.
4.15 Export of Drugs
4.15.1 List of products exported to different countries
4.15.2 Tabulate product complaints and recall
4.16 Copies of Site Master File
4.16.1 The Master Copy of the Site Master File shall be with Head, Quality Assurance and Controlled Copies Shall be Distributed to the customers.
5.0 ABBREVIATIONS
5.1 GMP- Good Manufacturing Practices
5.2 SMF- Site Master File
6.0 ANNEXURE
Nil
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