1. General Information on the Manufacturer
   1. Contact information on the manufacturer
      • Name and official address of the manufacturer
      • Names and street addresses of the site, buildings and production units located on the site
      • Contact information of the manufacturer including telephone, fax, email and 24 hours telephone numbers
      • Name and number of the contact personnel in the case of product defects or recalls
   2. Authorised pharmaceutical manufacturing activities of the site.
      • Brief description of manufacture, import, export, distribution and other activities as authorised by the relevant Competent Authorities including foreign authorities with authorised dosage forms/activities, respectively; where not covered by the manufacturing authorisation
      • Type of products currently manufactured on-site (list in Appendix 2)
      • List of GMP inspections of the site within the last 5 years, including dates and name/country of the Competent Authority having performed the inspection. A copy of current GMP certificate (Appendix 3)
   3. Any other manufacturing activities carried out on the site
      • Description of non-pharmaceutical activities on-site, if any
2. Quality Management System of the Manufacturer
   1. The quality management system of the manufacturer
      • Brief description of the quality management systems run by the company and reference to the standards used
      • Responsibilities related to the maintaining of quality system including senior management
      • Information of activities for which the site is accredited and certified, including dates and contents of accreditations, names of accrediting bodies
   2. Release procedure of finished products
      • Detailed description of qualification requirements (education and work experience) of the Authorised Person(s) / Qualified Person(s) responsible for batch certification and releasing procedures
      • General description of batch certification and releasing procedure
      • Role of Authorised Person / Qualified Person in quarantine and release of finished products and in assessment of compliance with the Marketing Authorisation
      • The arrangements between Authorised Persons / Qualified Persons when several Authorised Persons / Qualified Persons are involved
      • Statement on whether the control strategy employs Process Analytical Technology (PAT) and/or Real Time Release or Parametric Release
   3. Management of suppliers and contractors
      • A brief summary of the establishment/knowledge of supply chain and the external audit program
      • Brief description of the qualification system of contractors, manufacturers of active pharmaceutical ingredients (API) and other critical materials suppliers
      • Measures taken to ensure that products manufactured are compliant with TSE (Transmitting animal spongiform encephalopathy) guidelines
      • Measures adopted where counterfeit/falsified products, bulk products (i.e. unpacked tablets), active pharmaceutical ingredients or excipients are suspected or identified
      • Use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis
      • List of contract manufacturers and laboratories including the addresses and contact information and flow charts of supply-chains for outsourced manufacturing and Quality Control activities; e.g. sterilisation of primary packaging material for aseptic processes, testing of starting raw materials etc, should be presented in Appendix 4
      • Brief overview of the responsibility sharing between the contract giver and acceptor with respect to compliance with the Marketing Authorisation (where not included under 2.2) 
   4. Quality Risk Management (QRM)
      • Brief description of QRM methodologies used by the manufacturer
      • Scope and focus of QRM including brief description of any activities which are performed at corporate level, and those which are performed locally. Any application of the QRM system to assess continuity of supply should be mentioned
   5. Product Quality Reviews
      • Brief description of methodologies used
3. Personnel
   • Organisation chart showing the arrangements for quality management, production and quality control positions/titles in Appendix 5, including senior management and Authorised Person(s) / Qualified Person(s)
   • Qualifications, experience and responsibilities of key personnel
   • Number of employees engaged in the quality management, production, quality control, storage and distribution respectively
   • Outline of arrangements for basic and in-service training
   • Health requirements for personnel engaged in production
4. Premises and Equipment
   1. Premises
      • Short description of plant; the location of the site and immediate environment adjacent to manufacturer
      • Size including floor area of premises, and list of buildings. If the production for different markets, i.e. for local, EU, USA, etc. takes place in different buildings on the site, the buildings should be listed with destined markets identified (if not identified under 1.1)
      • Simple plan or description of manufacturing areas with indication of  scale (architectural or engineering drawings are not required)
      • Nature of construction and finishes
      • Lay outs and flow charts of the production areas (in Appendix 6) showing the room classification and pressure differentials between adjoining areas and indicating the production activities (i.e. compounding, filling, storage, packaging, etc.) in the rooms
      • Lay-outs of warehouses and storage areas, with special areas for the storage and handling of highly toxic, hazardous and sensitizing materials indicated, if applicable
      • Brief description of specific storage conditions if applicable, but not indicated on the lay-outs
      1. Brief description of heating, ventilation and air conditioning (HVAC) systems
         • Principles for defining the air supply, temperature, humidity, pressure differentials and air change rates, policy of air recirculation (%).
      2. Brief description of water systems
         • Quality references of water produced
         • Schematic drawings of the systems in Appendix 7
      3. Brief description of other relevant utilities, such as steam, compressed air, nitrogen, etc.
   2. Equipment
      1. Listing of major production and control laboratory equipment with critical pieces of equipment identified should be provided in Appendix 8.
      2. Cleaning and sanitation
         • Brief description of cleaning and sanitation methods of product contact surfaces (i.e. manual cleaning, automatic Clean-in-Place, etc).
      3. GMP critical computerised systems
         • Description of GMP critical computerised systems (excluding equipment specific Programmable Logic Controllers (PLCs).
5. Documentation
   • Description of documentation system (i.e. electronic, manual)
   • When documents and records are stored or archived off-site (including pharmacovigilance data, when applicable): List of types of documents/records, Name and address of storage site and an estimate of time required retrieving documents from the off-site archive.
6. Production
   1. Type of products (References to Appendix 1 or 2 can be made)
      • Type of products manufactured including
      • list of dosage forms of both human and veterinary products which are manufactured on the site
      • list of dosage forms of investigational medicinal products (IMP) manufactured for any clinical trials on the site, and when different from the commercial manufacturing, information of production areas and personnel
      • Toxic or hazardous substances handled (e.g. with high pharmacological activity and/or with sensitising properties)
      • Product types manufactured in a dedicated facility or on a campaign basis, if applicable
      • Process Analytical Technology (PAT) applications, if applicable: general statement of the relevant technology, and associated computerized systems
   2. Process validation
      • Brief description of general policy for process validation
      • Policy for reprocessing or reworking
   3. Material management and warehousing
      • Arrangements for the handling of starting materials, packaging materials, bulk and finished products including sampling, quarantine, release and storage;
      • Arrangements for the handling of rejected materials and products.
7. Quality Control (QC)
   • Description of the Quality Control activities carried out on the site in terms of physical, chemical, and microbiological and biological testing.
8. Distribution, Complaints, Product Defects and Recalls
   1. Distribution (to the part under the responsibility of the manufacturer)
      • Types (wholesale licence holders, manufacturing licence holders, etc) and locations (countries or regional economic areas) of the companies to which the products are shipped from the site
      • Description of the system used to verify that each customer / recipient is legally entitled to receive medicinal products from the manufacturer
      • Brief description of the system to ensure appropriate environmental conditions during transit, e.g. temperature monitoring/ control
      • Arrangements for product distribution and methods by which product traceability is maintained
      • Measures taken to prevent manufacturers’ products to fall in the illegal supply chain 
   2. Complaints, product defects and recalls
      • Brief description of the system for handling complaints, product defect and recalls.
9. Self Inspections
   • Short description of the self inspection system with focus on criteria used for selection of the areas to be covered during planned inspections, practical arrangements and follow-up activities.

Appendices

References :

1. Content of a site master file; Forty-fifth report of the WHO Expert Committee on Pharmaceutical Preparations, Geneva, 18 – 12 October 2010 (WHO Technical Report Series 961)
2. Explanatory notes for pharmaceutical manufacturers on the preparation of a site master file; PE 008 – 4, 1 January 2011, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
3. Site Master File; Third Edition, 2014, National Pharmaceutical Regulatory Agency, Malaysia

The list of approved local manufactures – Medicines

The list of approved local manufactures – Medical Devices

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