Site master file
Purpose
To lay down a procedure for preparation of Site Master
File.
Procedure
Content of Site Master File
General Information On the Site
Give brief information of organization describing the
regulatory credential available along with activities performed.
Contact Information on Site
Name and official address of the Site;
Names and street addresses of the site, buildings and
production units
located on the site;
Contact information of the manufacturer including 24
hrs telephone
number of the contact personnel in the case of product
defects or recalls;
Authorized pharmaceutical manufacturing activities of
the site
Copy of the valid manufacturing authorization issued by
the relevant
Competent Authority in Appendix 1;
Brief description of manufacture, import, export,
distribution and other
activities as authorized by the relevant Competent
Authorities including
foreign authorities with authorized dosage
forms/activities, respectively;
where not covered by the manufacturing authorization;
Type of products currently manufactured on-site
List of GMP inspections of the site within the last 5
years;
Any other manufacturing activities carried out on the
site
Description of non-pharmaceutical activities on-site,
if any.
Quality Management System
The Quality Management System
Following to be describe under this heading:
Give the details of quality management system
implemented at site. It shall briefly describe quality policy and the
responsibilities of various quality functions.
Responsibilities related to the maintaining of quality
system including senior management;
Information of activities for which the site is
accredited and certified, including dates and contents of accreditations, names
of accrediting bodies.
Release procedure of finished products
Give the details of batch release procedure of finished
product followed at site along with the responsibilities of department for
batch release.
Management of suppliers and contractors
Give brief description of supply chain management for
material procurement.
Brief procedure to be given for the vendor
qualification of active pharmaceutical ingredients (API), excipients, critical
packaging material etc. including compliance procedure for product free from
risk of TSE/BSE
Brief description of contract testing
laboratory/manufacturing sites and assessment procedure for their quality
system. It shall be briefly describe complete address, phone numbers, fax
numbers, contact person, responsibilities of contract giver and accepter etc.
Quality Risk Management (QRM)
Brief description of QRM methodologies used by the
site;
Product Quality Reviews
Brief description for the procedure of preparation and
review of product quality review.
Personnel
Give details of organization chart showing agreement
for manufacturing, Quality Assurance, Quality Control, Packaging and other
department.
Brief description of number of employees engaged in the
quality management, production, quality control, warehouse etc. It shall also
briefly describe training procedure and minimum health requirement for the
personnel working in manufacturing area.
Premises and Equipment
Premises
Give brief description of manufacturing areas with
indication of scale. It shall also describe the layouts and flow charts of
production areas.
Give brief description of room classification and
pressure differentials between adjoining areas with indication the production
activities (i.e. Dispensing, manufacturing, Filling, Storage & packaging
etc.) in the rooms.
Brief description of specific storage conditions for
material at site if any.
Brief description of Air Handling Unit (AHU) system.
Description of air supply, temperature, humidity,
pressure differentials and air change rates, policy of air recirculation (%).
Brief description of water system including quality
references of water produced and schematic drawings of system.
Brief description of utility system, such as steam,
compressed air, nitrogen etc.
Equipment
Give details of major equipments/instruments of
production and quality control laboratory and their cleaning and maintenance
procedure.
Documentation
Give brief description of GMP documents like
Preparation, revision, control, distribution, storage and retrieval.
Brief description of different documents involved in
manufacturing activities from the receipt of material to product dispatch.
Production
Type of Products
Give details of types of products handling at site. It
shall also briefly describe if any toxic or hazardous substances handled at
site.
Brief information to be given about manufacturing
operation. Mentioning the way of product are getting manufactured in dedicated
facility or campaign basis (if any).
Process Validation.
Give details of validation policy. It shall describe
briefly qualification procedure of equipment including utilities and analytical
instruments.
Brief information of manufacturing process/cleaning
validation.
Policy for reprocessing or reworking.
Material Management and Warehousing
Give details for arrangements of raw/packaging
materials, bulk and finished products including sampling, quarantine, storage
and release.
Brief description of procedure for the handling of
rejected raw/packaging material, finished product and their destruction
procedure.
Quality Control
Brief description of the quality control activities in
terms of physical, chemical, microbiological and biological testing.
Distribution, Complaints, Product Defects and Recalls
Distribution
Brief description related to storage condition and
distribution procedure of finished product. This shall also include full
traceability to track the goods dispatched.
Complaints, Product Defects and Recalls
Brief description of the procedure for handling
complaints, product defects and recalls.
Self Inspections
Brief description of the procedure for self inspection
system including frequency of self inspection, follow-up and CAPA procedure
etc.
Following separate annexure shall be attached along
with Site Master File duly signed by QA personnel.
Copy of valid manufacturing authorization.
List of dosage forms manufactured at site including
name of active pharmaceutical ingredients (API) used.
Copy of valid GMP Certificate.
List of External Contract Laboratories and services
including the addresses and contact information.
Organizational Charts (Organogram of
Manufacturing/QA/QC personnel etc.)
Layouts of production areas including material and
personnel flow.
Schematic drawings of Water System
List of major Production, Laboratory and Utility
equipment/instruments.
Any information w.r.t. above annexure during review
period shall be provided as an addendum to SMF.
Document No.: Unique alphanumerical identification no.
Effective Date: Date of implementation of SMF.
Review Date: The date on which SMF shall be reviewed.
Format of Site Master File
It shall contain covering page followed by approval page,
table of contents and description of contents.
A Site Master File should contain adequate information
but, as far as possible, not exceed 25-30 pages plus appendices.
Covering page of SMF shall contain information as
below:
Photograph of the site
Document No. : Unique alphanumerical identification no.
allotted to the site master file
Effective Date : Date of implementation of SMF.
Review Date : The date on which SMF shall be reviewed.
