The site master file contains detailed information about the site’s quality management strategies and activities, the production and/or quality control of the pharmaceutical manufacturing procedures performed at the specified site and any closely integrated operations in adjacent and nearby premises. The site master file should be prepared to carry out any pharmaceutical operation on site, including analysis, packaging, etc.
The main site file is for production and control of manufacturing processes. The site master file should be part of the documents that belong to the manufacturer’s quality management system and be restructured as a result. The site’s master file must contain the version number, effective date, and revision date. It should be subject to regular review to ensure that it is up to date and representative of current activities. The SMF must include the following sections:
General information about the manufacturer
Manufacturer’s quality management system
· Personnel
· production
· Quality control
Contract manufacturing and analysis
Distribution, complaints and product recall
Personal expectations
1. General information about the manufacturer:
Include the name, contact information, and official address of the manufacturer
Names and street addresses of the site, buildings and production units on the site
Website identification number
A copy of the valid manufacturing license issued by the competent authority
Brief description of manufacture, import, export, distribution and other activities authorized by relevant competent authorities including foreign authorities which have authorized dosage forms/activities, respectively
The type of products currently manufactured at the site
2. Manufacturer Quality Management System:
A brief description of the quality management systems operated by the company and a reference to the standards used
Responsibilities related to maintaining the quality system, including senior management
A general report on batch certificate issuance and release procedures
The role of the authorized person/eligible person in the quarantine and release of finished products and in the assessment of compliance with marketing authorization
Brief summary of established/knowledge of supply chain and external audit programme
Brief description of the qualification system for contractors, active pharmaceutical ingredient (API) manufacturers, and other critical material suppliers
3. Staff:
An organization chart showing the arrangements for quality management, production and quality control positions/titles, including senior management and qualified person(s)
The number of workers in quality management, production, quality control, warehousing and distribution, respectively
4. Production:
Briefly describe the production process. It also includes information on arrangements for handling rejected materials and products.
Description of labeling, disposal, storage and destruction of rejected materials
Brief outline of the process validation protocol
5. Quality control:
Quality control is another feature at A Main site file for the pharmaceutical industry. It constitutes a description of the quality control system and all activities of the quality control department. Also include the procedure for releasing finished products
6. Contract making and analysis:
This section provides information about the manner in which contract recipients’ compliance with GMP is assessed.
7. Distribution, Complaints and Product Recall:
This section includes:
Distribution arrangements and registration systems
Handling complaints
Types of companies to which products are shipped from the site
Product recall information
Warehousing and distribution practices
8. Self-inspection:
Briefly describe the self-inspection program
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