Site Master File
Uploaded by
Dharmesh PatelSite Master File
Uploaded by
Dharmesh PatelSite Master File (SMF) for pharmaceuticals
OBJECTIVE:
To provide written guidelines for preparation of Site Master File (SMF).
SCOPE:
The Site Master File provides brief information about the site and activities performed. This includes information
about personnel, facility, utility, equipment, documentations, productions, quality control and quality system.
RESPONSIBILITY:
Head QA
PROCEDURE:
Prepare a Site Master File containing about 25 to 30 A4 size pages as per contents given in Annexure.
Attach site plan, outline drawings or schematic layouts, pressure segregation as Annexure to the file.
Each page of SMF shall have the following header.
The Site Master File shall be prepared by ___, Reviewed By _____, Approved By Director Technical and Vice
President QA.
Copies of Site Master file are issued to Sr. V.P. Technical, Director Technical and V.P. QA.
Any amendment to the Site Master File shall be done only after getting prior approval from Sr. V.P. Technical,
Director Technical and V.P. QA
Copies of Site Master File can be requested from GM QA.
The SMF should contain information on the following sections
a) Contents page
b) Approval page
c) Issue details
General information
Brief information of the firm (including name and address), relation to other sites and, particularly, any
information relevant to understanding the manufacturing operations.
Pharmaceutical manufacturing activities as licensed by the national authority including validity period.
Any other manufacturing activities carried out on the site.
Name and Exact Address of the Site, Including Telephone, Fax and 24 Hrs Telephone Numbers.
Type of products manufactured on the site and information about specifically toxic, hazardous or sensitizing
substances handled e.g. antibiotics, hormones, cytotoxics if any. Also state if human and / or veterinary products
are both manufactured on the site.
Short description of the site including the location and immediate environment, the size of the site, types of
buildings, their ages.
Brief Description of Major Production and Control Laboratory Equipment with material of construction for
product contact equipment, are the equipment designed to ease cleaning. A list of equipment is not required.
Maintenance and servicing of equipment of production and utility.
Describe the Qualification, Validation and Calibration activities including the Company's general policy, and
protocols for qualification, prospective and retrospective validation.
Sanitation procedure: Availability of written specifications and procedures for cleaning manufacturing areas and
equipment.
Documentation
Preparation, revision and distribution of documentation for manufacture. Describe the documentation system,
responsibilities, storage of master documents, instructions for preparation of documents, procedure for control of
documents, retention time.
Any other documentation related to product quality. Describe other documents available which are not mentioned
elsewhere including the Equipment specifications, Specifications for disposables i.e. cleaning materials, Standard
operating procedures.
Production
Brief description of production operations. Describe the operations capable of being carried out at the site with the
existing facilities using flow sheets and charts specifying important parameters. Technical details are not required.
Arrangements for the handling of rejected materials and products.
Describe the labelling, storage, disposal and destruction of rejected material and products.
Policy for process validation
Provide a brief outline of process validation protocol.
Quality Control
Description of the Quality Control system and of the activities of the Quality Control Department. Procedures for
the release of finished products.
Contract manufacture and analysis
Description the way in which the GMP compliance of the contract acceptor is assessed.
Distribution, complaints and products recall
Arrangements and recording system for distribution.
Provide a brief description of Storage and Distribution Practices, conditions of storage in ware house.
Records and Distribution
Do the retained records permit full batch traceability from the factory to the customer, in terms of the date of sale,
customer details and quantity despatched?
Handling of complaints
Define responsibilities for Logging, Classifying, and Investigation of complaints. Reports prepared, review,
retention time of records.
Product recalls
Describe responsibility for product recalls, sequence of actions for Retrieval of distribution data, Notification to
customers, Receipt/segregation/inspection of returned product, Investigation/reporting of cause, Reporting
corrective action.
Self Inspection
Short description of the self inspection program.
