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.
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