Preparation of Site Master File (SMF)

What is SMF :

A Site Master File (SMF) is a document that describes the structure of the organization which includes the site, the manufacturing activities carried out, the facility and premises, number of employee with their Qualification, Production system, Quality Control System and also details of the quality management system which are in place.

Reference : WHO Technical Report Series, No.961, 2011. Annex 14 WHO guidelines for drafting a site master file 7 and EudraLex Volume 4 GMP Guideline

Content of Site Master File :

1. General Information on the Organization
2. Quality Management System
3. Personnel
4. Premises and Equipment
5. Documentation
6. Production System
7. Quality Control System
8. Distribution, Complaints, Product Defects and Recalls
9. Self-inspection system
10. Site Inspection History

1. General Information on the Organization :

Brief Information of Firm which include site location, surrounding environment, and size of the different section in square meters and other relevant information. Name and address of Manufacturing Site and Head Office including 24 hr’s contact Number. Brief information of type of Dosage forms manufactured at the site. (e.g. Solid Oral, Liquid, Parental or any other) and details of pharmaceutical manufacturing activities as licensed by the national authorities. Details of product manufactured at the site and information about any specifically toxic or hazardous substances handled.

2. Quality Management System :

It shall include the responsibility of various quality functions describing the role of Corporate Quality Assurance (CQA) and Site Quality Assurance (QA). Describe the detailed elements of Quality System, Audit Programs, Product Quality Review, Management review and Vendor Approved System. Responsibility and functions of Quality assurance in brief including Batch release System, Quality Risk Management system,Out of specification, Out of Trend, Incident, Change control, Deviation, Market Compliant and VMP,etc. Quality management system also includes audit programmed of supplier & contract laboratories list covering name & Address etc.

3. Personnel :

The details related to number of employees with their qualification, experience and responsibility of key personnel and organization chart showing reporting structure for Manufacturing, Packaging, Quality Control, Quality Assurance, Engineering and other departments at facility.

4. Premises and Equipment :

Elaborate about nature of construction and fixures or fitting, Built-up area with plant layouts and Outline about Air handling units (AHU), Air cooling units (ACU) & Air Ventilation Units at facility with their quantities and description of filter details used with various  tests carried out etc. Details about pre-treatment, water purification, Sanitation of water generation & distribution system and details about compressed Air system, steam etc. Details about list out the manufacturing, packaging & quality control Instruments/ equipment etc.

5. Documentation :

Documentation for all the activities starting from the receipt of material to conversion into finished goods and transfer to Finished Goods Store (FGS).

It includes the information related to documents received from Corporate Quality Assurance (CQA).

It also gives information related to handling of various documents like SOP’s, OOS, Market Complaints, Deviation, Incidents, Self-Inspection and other relevant information of documentation practices. Preparation, revision  and distribution of necessary documents and their controls.

6. Production System :

Brief description of production operations with process flow charts.

General policy for process validation & inter-departmental role for its execution and details of material management and warehousing & about starting material, semi finished, finished product, rejected raw material, rejected packing material & rejected drug products etc.

7. Quality Control System :

Information on different aspects and functions of Quality control department at the site which include information related to Raw material and Finished Product and information related to testing of the material/ product, review of the documents and release system etc.

8. Distribution, Complaints, Product Defects and Recalls :

Brief information related to storage condition of the Finished Product at the site, temperature condition requirement, stacking of goods, labeling for easy identification and other dispatch details. Procedure for handling of market complaint , categorization of complaint & closing of the same and also give the procedure for handling of product recall, Mock recall, investigation of the product, reconciliation of the goods etc .

9. Self-inspection system :

Periodic self-inspection is carried out to assess the compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). The Self-Inspection (Internal Audit) System should be followed at the site which helps for identifying the non-compliance and verifying the compliance within the target completion date.

The observations during the audit are noted down and are addressed by the responsible personnel in a set time frame. The implementation of the Corrective actions and Preventive action are done within a defined time frame which are resulted in Internal audit.

10. Site Inspection History :

Site inspection includes regarding approval of the regulatory agency for the facility or inspection of the site etc. with Name of regulatory audit, date and certificate required to be attached to SMF.

General Information :

  1. Site Master File shall be prepared by Quality Assurance, reviewed by Head Production, Head Quality Control and Head Engineering and Approved by Quality Head.
  2. The annexes or the attachments like FDA Product approval license copy, Site drawings and schematic layouts, schematic diagram of water, Floor Plans, Organogram of employee, Process flow diagram of product, List of Equipments & instruments of Manufacturing and Quality control and site regulatory approval copies shall be attached to SMF.
  3. SMF shall be revised at a interval of 02 years & when ever required.
  4. Site master file is a important documents for the organization and this is first documents which can be presented to the Auditors during audits.

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