5.1 General instruction for preparation of Site Master File:
5.1.1 The information to be entered in the Header shall be as detailed below.
5.1.2 Title “SITE MASTER FILE”.
5.1.3 Company logo, name & address of the site.
5.1.4 SMF Number.
5.1.4.1 This indicates the Site Master File number along with the version number.
5.1.4.2 For the purpose of reference in any document, SMF No. shall be quoted without version number
5.1.5 Effective Date: This indicates the implementation date of site master File. It shall be dated as ´dd mmm yyyy‘. e.g. if the Site Master File is effective from 1st January 2022 shall be dated/stamped as 01 JAN 2022.
5.1.6 Page No.: This is written in ‘X of Y’ format where ‘X’ indicates page number and ‘Y’ indicates total number of pages of the site Master File excluding annexure e.g. 1 of 30 indicates first page out of the total 30 pages.
5.2 Site Master File Numbering System:
5.2.1 This is an alphanumeric number consisting of 10 characters. A typical SMF numbering mentioned as below.
XXX/SMF/01-YY
Where:
XXX: First three letter of the company name.
SMF: Site Master File
YY : Version number of SMF starting with ‘00’ the next version will be 01 and so on.
Note: The annexure in the Site Master File are numbered as A01, A02…with prefix of SMF No. (i.e. XXX/SMF/01-A01).
5.3 Preparation, Review and Approval of Site Master File:
5.3.1 Site master file shall be prepared as per the guidelines of various regulatory authorities.
5.3.2 A Site Master File should contain adequate information but, as far as possible, not exceed 25-30 pages excluding annexures.
5.3.3 Simple plans, outline drawings or schematic layouts shall be used instead of narratives.
5.3.4 The Site Master File, including annexures, should be readable when printed on A4 paper.
5.3.5 The Site Master File shall contain the following but not limited to:
5.3.5.1 General information of the Site
5.3.5.2 Quality Management System
5.3.5.3 Personnel
5.3.5.4 Premises and Equipment
5.3.5.5 Documentation
5.3.5.6 Distribution, Complaints, and Product Recalls
5.3.5.7 Self Inspection
5.3.6 QA shall prepare a draft copy of SMF and put ‘DRAFT COPY ‘stamp/ watermark and shall circulate to all the department and QA for review.
5.3.7 Upon receipt of draft copy the reviewer shall review and send comments to the QA for incorporating the same in the final copy of SMF.
5.3.8 After incorporation of suggestions(s) as applicable, the SMF shall be forwarded for approval. Draft copy shall be destroyed by shredding after the approval of the SMF.
Note: Site master file shall be specific to each regulatory region and shall be prepared on need basis (if required).
5.3.9 QA shall distribute the control copy of SMF to Head Operations / Managing Director, Site Head and Head QA.
5.4 Revision of Site Master File:
5.4.1 Site Master File shall be reviewed once in every two years or as and when required.
5.4.2 If there are changes in the content of Site Master File, A Change Request form shall be raised for the changes that are desired / deemed necessary in the existing procedure.
5.4.3 QA shall raise a ‘Change Request Form’ as per SOP of ‘Change Control Programme’.
5.4.4 After approval of Change Request Form, QA shall revise the SMF with next version number.
5.4.5 All the changes made in the revised SMF shall be entered in brief in the ‘Revision History’.
5.4.6 Revision history shall indicate changes associated with each of the version and attached at the end of the SMF.
5.4.7 If there are no changes required during the routine review, change history shall be revised mentioning ‘Review done-No change required’.
5.4.8 Revised and approved change history shall be attached to the Site master file and shall be issued to the concerned personnel.
5.4.9 Old copy of the revision history shall be returned by the concerned personnel and destroyed by the QA person.
5.4.10 If there is a change in the annexure, which does not result in any change in the text of the SMF, then the Annexure shall be revised with new version number and effective date. A change control Note shall be raised, which shall be attached at the end of the Site Master File.
5.4.11 Annexures, which are contain information changing frequently i.e. List of Employees, List of products etc. shall be updated at least once in 6 months or whenever required.
5.4.12 Issuance, control and retrieval of Site Master File shall follow the Procedure for Documentation control.