The Site Master File is made with the objective to provide all site information like facility, process, Quality systems, and who’s who and to describe the firm’s general policy on Quality Assurance Systems and Documentation. It is designed to facilitate the various regulatory agents to have standard inspection and reporting systems. The Site Master File is formatted as per the current Site Master File Guidelines issued by UKMCA.
All the required information has been described under Para C.1 to C.9 with self-explanatory sub-titles. The Site Master File will be upgraded and improved from time to time in order to facilitate inspection and to update as per the changes made in Quality Systems.
Detailed Index for Site Master File
Sr. No. Topic C.1 General Information C.1.1 Brief Information C.1.2 Licensable Activities C.1.3 Other Activities on Site C.1.4 Name and Address C.1.4.1 Manufacturing facility C.1.4.2 Corporate Office C.1.4.3 24 Hours contact telephone number C.1.5 Types of actual Products manufactured on the site C.1.6 Description of Site C.1.6.1 Location and immediate environment C.1.6.2 Site and building description C.1.7 Employees Engaged in QC & QA, Production, Warehouse, Engineering & Utility, and Personnel C.1.8 Technical Assistance from Outside Party C.1.8.1 Name and address C.1.8.2 Telephone Nos. C.1.8.3 AMC (Annual Maintenance Contract) C.1.9 Quality Management System of the firm C.1.9.1 Quality Policy C.1.9.2 Responsibility of Quality Assurance C.1.9.3 Elements of Quality Assurance System C.1.9.4 Audit Programmes C.1.9.5 Review of results for adequacy of Quality system C.1.9.6 Standards used by the company C.1.9.7 Vendor Audit C.2 Personnel C.2.1 Organization Chart C.2.1.1 Organograms C.2.2 Key personnel (Quality Assurance, Quality Control, Production, Formulation Development, Engineering, Stores, and Personnel) C.2.3 Basic and In-service Training and Maintenance of Records C.2.3.1 Identification of training needs C.2.3.2 GMP Training
C.2.3.3 Training Methods C.2.3.4 Training assessment C.2.3.5 Training records C.2.4 Health Requirements for personnel engaged in Production C.2.4.1 Health checking of employees- Responsibility C.2.4.2 Pre-employment medical examination C.2.4.3 Routine health checkups of employees C.2.4.4 Reporting of sickness and action were taken in case of a sick employee C.2.4.5 System for reporting back after Illness C.2.5 Personnel Hygiene requirements C.2.5.1 Washing, changing, and resting areas C.2.5.2 Description of clothing C.2.5.3 Change of clothing C.3 Premises & Equipment C.3.1 Premises C.3.1.1 Legibility of plan C.3.1.2 Classification of area C.3.2 Nature of Construction and Finishes C.3.2.1 Narration of plant C.3.3 Nature of Construction and Finishes C.3.2.1 Narration of plant C.3.2.2 Description of processing and packing areas C.3.4 Description of Ventilation System C.3.4.1 Design Criteria of ventilation systems C.3.4.2 Filter Design and Efficiency C.3.4.3 Limits for changing filters C.3.4.4 Di-octyl phthalate test – details C.3.4.5 Frequency of revalidation C.3.5 Special areas for handling highly Toxic Hazardous and Sensitizing Material C.3.6 Brief Description of Water System C.3.6.1 Purified water generation system C.3.6.2 Water for injection generation system C.3.6.3 Capacity of the water system C.3.6.4 Material of construction Related: Drug master file (DMF)
C.3.6.5 Specification of filters C.3.6.6 Water Storage and circulation details C.3.6.7 Specification of water C.3.7 Maintenance and Servicing of AHUs and Water System C.3.7.1 Description of preventive maintenance program C.3.7.2 Reporting procedure for maintenance and servicing C.3.7.3 Maintenance routines C.3.7.4 Reports of maintenance C.3.8 Brief Description of Major Production and Control Laboratory Equipment C.3.8.1 Material of construction Brief Description of Major Production and Control Laboratory Equipment C.3.8.2 Validation of materials other than stainless steel C.3.8.3 Design based on ease of cleaning C.3.8.5 General description of quality control equipment C.3.8.6 General description of microbiological equipment C.3.8.7 Usage of computers C.3.9 Maintenance and Servicing of Equipment C.3.9.1 Responsibility for maintenance and servicing C.3.9.2 Contractual Details for outside work C.3.9.3 Affect of maintenance routines on product quality C.3.9.4 Recording procedure of maintenance works C.3.10 Qualification, Validation and Calibration C.3.10.1 Validation policy C.3.10.2 Revalidation policy C.3.10.3 Process validation C.3.10.4 Release for sale or supply of development and validation batches C.3.10.5 Software validation C.3.10.6 Equipment calibration policy and Record.
C.3.11 Sanitation C.3.11.1 Procedure for cleaning C.3.11.2 Change of cleansing agents C.3.11.3 Validation of cleaning procedures C.3.11.4 Monitoring of cleaning methods C.3.11.5 Cleaning methods used for water supply, air handling, and dust extraction systems C.4 Documentation C.4.1 Preparation, revision, and distribution of documents C.4.1.1 Description of documentation system C.4.1.2 Responsibility for preparation, revision, and distribution of documents C.4.1.3 Storage of master documents C.4.1.4 Standard formatting for documentation C.4.1.5 Control of documentation C.4.1.6 Retention period for documents C.4.1.7 Electronic storage of documentation C.4.2 Other documentation related to product quality C.4.2.1 Equipment specifications C.4.2.2 Specifications for cleaning materials C.4.2.3 Standard operating procedures C.4.2.4 Quality control procedures C.4.2.5 Training procedures C.4.2.6 Computer program specifications C.4.2.7 Documentation control of process deviation C.4.2.8 Calibration and test documents C.4.2.9 Validation documents C.4.2.10 Reconciliation of materials C.5 Production C.5.1 Description of production operations C.5.2 Material handling during the manufacturing process C.5.2.1 Control of bulk manufacture C.5.2.2 Packing C.5.2.3 Quarantine and release of the finished product C.5.2.4 Role of authorized persons
C.5.3 Arrangements for handling rejected materials and products C.5.3.1 Labeling of reject materials/products C.5.3.2 Disposal of reject materials /products C.5.4 General policy for process validation C.6 Quality control C.6.1 Activities of Quality Control Department C.6.1.1 Description of QC activities C.6.1.2 Review and release of the final batch documentation C.6.1.3 Preparation, revision, and distribution of specifications and standard testing procedures C.7 Contract manufacture and analysis C.7.1 Details of technical contract C.8 Distribution complaints and product recall C.8.1 Distribution C.8.1.1 Security of warehouse C.6.1.3 Preparation, revision, and distribution of specifications and standard testing procedures c.8.1.3 Refrigeration storage C.8.1.4 Storage of materials C.8.1.5 Labeling of products C.8.1.6 Reject material storage C.8.1.2 Environmental Control of Warehouse C.8.1.8 Dispatch order C.8.2 Records of distribution C.8.3 Complaints C.8.3.1 Responsibility matrix for handling C.8.4.1 Responsibility Matrix for Product Recalls C.8.3.3 Review of market complaint reports C.8.3.4 Retention period for market complaints records C.8.4 Product recall C.8.4.1 Responsibility Matrix for Product Recalls C.8.4.4 Involvement of competent authority in Recalls C.8.4.3 Notification of Recall to competent authorities C.8.4.4 Involvement of competent authority in Recalls C.8.4.5 Effectiveness of recall below wholesales level C.8.4.6 Previous product recalls Self-inspection C.9 Effectiveness of the Quality System C.9.1 Description of self-inspection C.9.2 Effectiveness of the Quality System
Annexure No. Topic I Site Layout II Layout for API Warehouse III Layout for – Ground IV a) Vendor Registration Form b) Vendor audit and Development Form c) Vendor Quality Audit Checklist d) Vendor Assessment and Approval Checklist e) Checklist for Provisionally Approved Vendor f) Proposed plan for Vendor Audit g) Vendor Audit Execution Schedule V a) General Organogram b) QMS Organogram VI a) Orientation Schedule b) Training Need Identification c) On Job Training Records d) GMP Training Records e) External Training Records f) Annual Planner for GMP Training VII Area Classification for Layout VIII AHU Distribution IX Design Specification for HVAC X a) Pre-treatment Sampling Points b) Purified Water Sampling Points c) WFI Sampling Points XI a) Work Order b) Equipment History Card c) Monthly Preventive Maintenance Program d) Preventive Maintenance Plan e) Monthly Breakdown Analysis f) Critical Breakdown Maintenance Analysis & Restart Procedure Memo
XII Preventive Maintenance Execution And Planning XIII List Of Production Equipment XIV List Of Quality Control Equipment XV List Of Microbiology Equipment XVI List Of Engineering & Utility Equipment XVII Standard Format For Standard Operating Procedure XVIII Change Control Request (CCR) Form XIX Deviation Form XX Product Complaint Form XXI Market Complaint Investigation Form XXII a) Product Recall Report b) Product Recall Conclusion Form c) Standard Product Recall Letter d) Product Recall Withdrawal Procedures XXIII b) Self-inspection Report d) Self-inspection Conclusion Report c) Proposed Corrective Action Report e) Follow-up Inspection Report