SOP on Preparation of Site Master File
Objective: To lay down the procedure for the preparation of Site Master File.
Scope: Site Master File covers Facility, Premises, Equipment, Personnel, Quality System, and Utilities to formulation plant.
Responsibility: Officer / Sr. Officer- QA
Accountability: Head – QA
Procedure:
Site Master File shall be prepared by QA Personnel.
Format for site master file:
The Site Master File should on A4 Size paper with font type Arial only and font size 11.
The header should be in side the border with the margin 1”.
Page margin should be 1” for top/left & bottom and 0.7” for right margin.
The width of page border should be 1 pt.
Cover page of SMF:
The cover page of SMF shall be without Header and footer and the page numbering shall be start from the cover page but page no. shall not display on the cover page.
The cover page shall contain following information:
Site master file :(font size 36)
Document No. : (font size 11)
Supersedes :(font size 11)
Effective Date : (font size 11)
Review Date :(font size 11)
No. Of Pages :(font size 11)
Site Address : (font size 20)
Site Master File shall be approved by Head – QA.
Place the approval page to approve the site master file and the approval page shall be as follows:
The numbering of site master file shall be assigned as follows:
The first three characters ‘NLL’ denote the “Nectar Lifesciences Limited”.
The 4th character shall be always slash ‘/’.
The 5th, 6th & 7th character ‘SMF’ shall denotes the “Site Master File”.
The 8th character shall always be slash ‘/’.
The 9th & 10th character shows the major change in SMF.
The 11th character shall always be dash ‘-’.
The 12th & 13th character shows the “revision no.”
A list of contents shall be as per Annexure – QASP013/A01.
Attach all relevant information in the form of Annexure like Site Map, Organogram, Layout