Local master file in the pharmaceutical industry

The on-site master file contains detailed information on site quality management strategies and activities, manufacturing and / or quality control of drug manufacturing processes at the designated site, and activities closely integrated in adjacent and nearby buildings. A local master file shall be created for any on-site pharmaceutical operation including analysis and packaging, etc.

The site's master file is dedicated to control production and production operations. The on-site masterfile shall be part of the manufacturer's quality management system documentation and shall be reorganized accordingly. The site's master file must have a release number, an effective date, and a review date. It should be periodically reviewed to ensure it is up-to-date and representative of current activities. The SMF must include the following sections:

· General information from the manufacturer

· The manufacturer's quality management system

· Staff

· Production

· Quality control

· Contract preparation and analysis

· Distribution, complaints and product recall

· Selfcheck

1. General information about the manufacturer:

· Provide the manufacturer's name, contact information and official address

· Name and address of the site, building and site

· Site identification number

· A copy of the valid manufacturing authorization issued by the competent authority

· Brief description of manufacture, import, export, distribution and other activities authorized by the competent authorities, including foreign authorities with authorized dosage forms / activities

· The type of products currently manufactured locally

2. Manufacturer's quality management system:

· A brief description of the quality management systems used by the company and a reference to the standards applied

· Responsibility for maintaining the quality system, including senior management

· General Report on Batch Certification and Release Procedure

· Role of Authorized / Qualified Person in Quarantine and Release of Finished Products and Assessment of Compliance with Marketing Authorization

· Brief summary of supply chain / external audit program creation / knowledge

· Brief description of the qualification system of contractors, API manufacturers and suppliers of other critical substances

3. Staff:

· Organization chart showing the layout of the quality management, manufacturing and quality control positions / titles including senior management and qualified personnel

· Number of people employed in quality management, production, quality control, storage and distribution

4. Production:

· Brief description of the manufacturing operation. It also contains information on rules for handling rejected materials and products.

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

· A brief description of the process validation protocol

5. Quality control:

Quality control is another feature in the Pharmaceuticals Site Master file. This is the description of the quality control system and all the activities of the quality control department. It also includes a procedure for the release of finished products

6. Contract generation and analysis:

This section describes the GMP compliance assessment of the contract acceptor.

7. Distribution, complaints and product recall:

This section includes:

· Distribution arrangements and fixing systems

· Complaints handling

· The types of companies to which the products are shipped from the site

· Product recall information

· Storage and distribution practices

8. Self-check:

· Describe briefly the self-monitoring program