February 23, 2024

The Site Master File contain detailed information about the quality management strategies and activities of the site, the production and/or quality control of pharmaceutical manufacturing procedures carried out at the named site and any closely integrated operations in neighboring and nearby buildings. A Site Master File need to be prepared for carrying out any pharmaceutical operation in the site, including analysis and packaging, etc.

The site master file is dedicated to production and control of manufacturing operations. The Site Master File should be a part of documents belonging to the quality management system of the manufacturer and kept restructured consequently. The Site Master File should have an edition number, the date it becomes effective and the date by which it has to be reviewed. It should be subject to regular review to ensure that it is up to date and representative of current activities. The SMF should include the following sections:

· General Information on manufacturer

· Quality management system of the manufacturer

· Personnel

· Production

· Quality Control

· Contract manufacture and analysis

· Distribution, complaints and product recall

· Self-Inspection

1. General Information on Manufacturer:

· Include name, contact information and official address of the manufacturer

· Names and street addresses of the site, buildings and production units located on the site

· Identification number of the site

· Copy of the valid manufacturing authorization issued by the relevant Competent Authority

· Brief description of manufacture, import, export, distribution and other activities as authorized by the relevant Competent Authorities including foreign authorities with authorized dosage forms/activities, respectively

· Type of products currently manufactured on-site

2. 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

· General report of batch certification and releasing procedure

· Role of authorized Person / Qualified Person in quarantine and release of finished products and in the assessment of compliance with the Marketing Authorisation

· 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

3. Personnel:

· Organization chart showing the arrangements for quality management, production and quality control positions/titles, including senior management and Qualified Person(s)

· Number of employees engaged in the quality management, production, quality control, storage and distribution respectively

4. Production:

· Description on production operation briefly. It also includes information on arrangements for the handling of rejected materials and products.

· Describe the labeling, disposal, storage and destruction of rejected material

· Brief outline of process validation protocol

5. Quality Control:

Quality control is another feature in a Site Master file of a pharmaceutical industry. It constitutes the description of the quality control system and all the activities of the quality control department. Also include the procedure for the release of finished products

6. Contract Manufacture and Analysis:

This section shows information on the way GMP compliance of the contract acceptor is evaluated.

7. Distribution, Complaints and Product Recall:

This section includes the following:

· Arrangements and recording systems for distribution

· Handling of complaints

· Types of the companies to which the products are shipped from the site

· Product recall information

· Storage and distribution practices

8. Self-Inspection:

· Describe briefly in the self-inspection program