A Site Master File is the full form of “SMF” and is a Quality document consisting of complete information about the quality management system, production/ pharmaceutical manufacturing operations, and quality control systems available at the site.
Site Master File SOP
Hence, it is always advised to have a Site Master File (SMF) SOP in each manufacturing plant as per the cGMP requirements.
SMF SOP Scope
This procedure is applicable for information about the site and activities performed at the <FIRM>. This includes information about personnel, facility, utilities, equipment, documentation, production activities, quality control activities, and quality management system.
Responsibility
QA personnel are responsible for the preparation, review, and approval of SMF.
Site Master File (SMF) Reference Guidelines
PIC/S: Explanatory note for Pharmaceutical Manufacturing on the preparation of a site Master file.
European Commission: EudraLex, Volume 4 – Explanatory note on the preparation of Site Master File.
WHO Annex 14 for the drafting of the Site Master File.
Site Master File Definition
A Site Master File (SMF) contains specific information about the quality management system in place, production and quality control of pharmaceutical manufacturing operations carried out at the site, and any closely integrated operations at adjacent and nearby buildings.
Site Master File (SMF) Standard Operating Procedure
Prepare a Site Master File by describing the structure of the organization, location of manufacturing activities, layout drawings and flow charts of the facility, and details of the quality management system. The site master file shall consist of the below contents.
- General information of the Manufacturer
- The quality management system of the manufacturer
- Personnel
- Building / Premises and equipment
- Documentation and records
- Production
- Quality control
- Distribution, complaints, product defects, and product recall
General information of the Manufacturer
Site Master File (SMF) shall consist of the General information of the Manufacturer as mentioned below.
Contact information on the manufacturer:
Name and complete official address of the site and registered office.
Contact person, including 24-hour telephone contact number/ mail ID.
DUNS (Data Universal Numbering System ) number, FEI number / Geographic Coordinates In Decimal and Degree (GPS).
Brief introduction/ description of the site.
Authorized pharmaceutical manufacturing activities of the site.
The information on valid Manufacturing licenses.
Description of manufacturing activities, export, and distribution.
Types of products manufacturing on-site.
List of GMP inspections of the site within the last 5 years.
Site Master File (SMF) – A quality management system of the manufacturer
Quality Management System
Quality Policy system.
Responsibility for Quality Unit including senior management.
Details of accreditation /Certification such as ISO standard etc.
Final Release procedure of APIs / intermediates (Dispatch Products)
Description and role of the responsible/ authorized/ qualified personnel involved in the batch release.
General system and procedure for batch certification and release, a brief overview of the control strategy.
Management of suppliers and contractors
A brief overview of the management of supply chain and external audits.
Qualification program of Key Starting material(s) and contractors.
List of scientific/analytical laboratories in relation to manufacturing and testing with complete addresses.
Quality risk management (QRM).
Annual Product Quality Reviews (APQR).
Site Master File (SMF) – Personnel
Organization chart showing the reporting relationships for quality assurance, quality control, production, engineering, and warehouse.
Qualifications and experience of key senior personnel.
A number of employees engaged in quality management (QA & QC), production, quality control, warehouse, engineering, etc…
A brief overview of a Training program for the personnel engaged in GMP activities.
Health requirements for personnel engaged in GMP activities including clothing.
Personnel hygiene requirements.
A brief overview of Pest & Rodent control systems.
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Site Master File (SMF) – Building / Premises and equipment
A Site Master File (SMF) shall consist of Building / Premises and equipment details as mentioned below.
Building / Premises
Layouts and flow charts of the production areas are available at the site including the room classification and pressure differentials between adjoining areas and indicating the flow of material, man, and production activities as per applicability.
Brief description of Cleanroom areas including the nature of constructions.
Layouts of warehouse and storage areas with the indication of specific areas of storage such as toxic, hazardous, etc…
Brief description of heating, ventilation and air conditioning (HVAC) systems.
Description of purified water systems including the source, water purification process, sanitation, and control (Briefly).
The description of other utilities such as; compressed air, nitrogen, steam, etc. (briefly).
Equipment
Brief description and list of major production and Quality control equipment/instruments.
Preventive maintenance of premises and associated equipment/system.
Qualification and calibration of equipment/system.
Cleaning and sanitation methods/procedures (manual cleaning, automatic clean-in-place, etc.) for the cleaning of manufacturing equipment during the batch-to-batch, product changeover, periodic cleaning, etc.
Qualification and validation of computerized systems.
Documentation and records
Description of document and record management system.
Brief of the Batch numbering system.
Site Master File (SMF) – Production
Precautions against mix-up and cross contamination
Process Validation
Brief description of general policy on process validation program.
Reprocessing and reworking policy/ Procedure.
Material management and warehousing
Arrangement for the handling of API starting materials, packaging materials intermediates, and finished APIs including sampling, quarantine, release, and storage.
Arrangements for the handling of rejected materials and products.
Disposal of waste
Site Master File (SMF) – Quality control
Description of the quality control activities in terms of physical, chemical and microbiological including a system for sampling and testing.
A brief overview of the Stability program of the API and intermediates.
Distribution, complaints, product defects, and product recall
Distribution
Brief distribution overview of markets such as the US, EU, WHO, etc.
Description of the system to ensure appropriate environmental conditions during the transit i.e. temperature monitoring and control, wherever applicable
Measures are taken to prevent manufacturers’ products to fall into the illegal supply chain.
Complaints, product defects, and product recalls
Brief description of the system for complaints management, return and recall.
Self-inspection
Short description of the self-inspection (Internal audit) system including follow-up program.
Annexures
The photocopies of the required annexure documents shall be attached to the Approved SMF.
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