Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Site Master File - January 17, 2025
- Key Notes on Revised Schedule M: Biological products - January 15, 2025
- Key Notes on Revised Schedule M: Sex Hormones - January 13, 2025
Last Updated on January 17, 2025 by The Health Master
Site Master File
Key considerations for Site Master File for compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Biological products
Good Manufacturing Practices for Pharmaceutical Products
Decoding the Site Master File: A Comprehensive Guide for Pharma Manufacturers
Key Points
What is a Site Master File?
- It is a document that has details about the Good Manufacturing Practices (GMP) being followed at a pharmaceutical manufacturing unit.
- The site master file provides a comprehensive overview of the manufacturing and quality control processes involved in the pharmaceutical manufacturing facility.
Key Components of a Site Master File:
General Information:
It provides the details of the company, manufacturing activities and details of the products permitted in the company, details of the employee, quality systems, and risk assessments done in the facility.
Personnel:
It contains the organizational structure of the company, qualifications and approval status of the key personnel, training programs of the employees, and medical health & hygiene requirements for the employees.
Premises:
Having the details of facility layout, construction of the building, ventilation systems provided in the company, process of handling of hazardous materials, water systems established in the facility, and preventive maintenance programs done in the facility.
Equipment
It contains a detailed description of all major equipment, preventive maintenance processes, and calibration procedures of the equipment.
Sanitation system:
Written processes and detailed procedures for cleaning manufacturing areas and equipment must be mentioned in the site master file.
Documentation:
It should contain all the documents related to the arrangements for preparing, storing, revising, and distributing all essential manufacturing and quality-related documentation.
Production:
It contains a detailed description of manufacturing operations, the process of handling materials, rejected materials, and the validation process of the manufacturing areas.
Quality Control & Quality:
The site master file must have the proper documentation system like change control, master validation plan, product quality review, and QC department activities done in the facility.
Loan License:
Having the details of procedures for maintaining and assessing GMP compliance of the loan licensees granted in the facility.
Distribution record & complaints:
The site master file must contain the distribution arrangements, handling of the complaint received about the product, and procedures and details of the product recall.
Self-Inspection:
Having the details of all the self-inspection conducted in the facility, including the involvement of external experts for the same.
Export of Drugs:
Must have the details of the export of the drugs, including the complaints of recall of the exported products.
Pharma manufacturers’ compliance with Revised Schedule M:
Accurate and updated information:
All the accurate and updated information must be there in the site master, which may include the current practice of manufacturing.
Documentation:
Maintain comprehensive records, and all the documents should be maintained properly with respect to all aspects of manufacturing and quality control.
Risk Assessment:
Regularly perform thorough and detailed risk assessments and implement prompt and appropriate mitigation plans.
Training of the employee:
All the personnel must be provided regular and detailed training to all personnel involved regarding the manufacturing and quality control.
Quality Management System:
The quality management system must be robust and aligned with GMP regulations.
Regular Reviews:
Conduct regular reviews with respect to internal and external audits for the assessment of compliance with GMP. Areas for improvement must be identified.
Deficiencies
Address the deficiencies promptly and investigate the issues effectively.
Stay Informed:
Always stay updated on the latest regulatory guidelines, circulars, notifications, and amendments to Schedule M.
Expert Guidance:
Always consult with qualified professionals or regulatory consultants and seek their guidance regarding ensuring compliance with all applicable regulations.
Please note: This information is for general guidance only and may not be exhaustive. Refer to the official regulations and any applicable guidance documents for specific requirements and interpretations.
Disclaimer: This information is for general guidance only and does not constitute legal or professional advice. Pharma manufacturers should consult with relevant regulatory authorities for specific guidance and compliance requirements.
Note: This article aims to provide a basic understanding of the Site Master File and its significance in pharmaceutical manufacturing. It is crucial for pharmaceutical companies to maintain a comprehensive and accurate Site Master File to ensure compliance with regulatory requirements and produce safe and effective medications.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Radiopharmaceutical Products ….coming soon
Understanding Airlock Systems in Pharma Industry
Airlocks in the Pharma Industry: An essential component
AHUs, Air Types, Air Changes and their Functions in Pharma Industry
Key Notes on Revised Schedule M: Compilation
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Blood Centre (Blood Bank)
Procedure to obtain license for Commercial Testing Laboratories
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
