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.<\/p>\n
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:<\/p>\n
General information about the manufacturer<\/p>\n
Manufacturer’s quality management system<\/p>\n
\u00b7 Personnel<\/p>\n
\u00b7 production<\/p>\n
\u00b7 Quality control<\/p>\n
Contract manufacturing and analysis<\/p>\n
Distribution, complaints and product recall<\/p>\n
Personal expectations<\/p>\n
1. General information about the manufacturer:<\/p>\n
Include the name, contact information, and official address of the manufacturer<\/p>\n
Names and street addresses of the site, buildings and production units on the site<\/p>\n
Website identification number<\/p>\n
A copy of the valid manufacturing license issued by the competent authority<\/p>\n
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<\/p>\n
The type of products currently manufactured at the site<\/p>\n
2. Manufacturer Quality Management System:<\/p>\n
A brief description of the quality management systems operated by the company and a reference to the standards used<\/p>\n
Responsibilities related to maintaining the quality system, including senior management<\/p>\n
A general report on batch certificate issuance and release procedures<\/p>\n
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<\/p>\n
Brief summary of established\/knowledge of supply chain and external audit programme<\/p>\n
Brief description of the qualification system for contractors, active pharmaceutical ingredient (API) manufacturers, and other critical material suppliers<\/p>\n
3. Staff:<\/p>\n
An organization chart showing the arrangements for quality management, production and quality control positions\/titles, including senior management and qualified person(s)<\/p>\n
The number of workers in quality management, production, quality control, warehousing and distribution, respectively<\/p>\n
4. Production:<\/p>\n
Briefly describe the production process. It also includes information on arrangements for handling rejected materials and products.<\/p>\n
Description of labeling, disposal, storage and destruction of rejected materials<\/p>\n
Brief outline of the process validation protocol<\/p>\n
5. Quality control:<\/p>\n