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1.0
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PURPOSE
To lay down systematic procedure for the preparation
of Site Master File, this briefs about the facility To lay down systematic
procedure for the preparation of Site Master File, this briefs about the
facility.
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2.0
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SCOPE
This method is applicable to the preparation of Site
Master File.
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3.0
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RESPONSIBILITY
QA Officer/Executive.
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4.0
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ACCOUNTABILITY
Head Quality Assurance.
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5.0
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.7.1
5.7.2
5.7.3
5.7.4
5.7.5
5.7.6
5.7.7
5.7.8
5.7.9
5.7.10
5.7.11
5.7.12
5.7.13
5.7.14
5.7.15
5.7.16
5.8
5.8.1
5.8.2
5.8.3
5.8.4
5.8.5
5.9
5.9.1
5.9.2
5.9.3
5.9.4
5.9.5
5.9.6
5.9.7
5.9.8
5.9.9
5.9.10
5.9.11
5.9.12
5.10
5.10.1
5.10.2
5.11
5.11.1
5.11.2
5.11.3
5.11.4
5.11.5
5.12
5.12.1
5.12.2
5.12.3
5.12.4
5.13
5.13.1
5.14
5.14.1
5.14.2
5.15
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PROCEDURE
Site
master file shall be prepared as a concise package of information on the
manufacturing site & in particular the production blocks for which the
site masters file shall be prepared.
Site master file shall be
prepared based on the contents described in World Health Organization (WHO)
technical series number 823. The contents are listed in Annexure – I.
Describe each content point briefly with
the help of concerned department.
Site master file shall be
numbered as follows;
SMF / YYYY – YY/ NN
SMF
: Site Master File
YYYY: The current calendar year.
- : Separator.
YY
: The last two characters of the next year.
/ :
Separator.
NN: The revision number starting
from 00.
The
Any required subsequent changes shall be
made as “Amendments” to the specific Site Master File.
The Numbering system for the Amendments
shall be as follows:
SMF / YYYY / NN/01
SMF
: Site Master File
YYYY: The current calendar year.
/ : Separator.
/
:
Separator.
NN : The revision number starting
from 00.
01 indicate Amendments No in ascending order starting with 01 .
The Site Master File shall be prepared under the following sub
headings:
General information.
Brief information of the firm,
which includes name & complete address of the firm.
Particular information relevant
to understand the manufacturing operation.
Pharmaceutical manufacturing
activity as licensed by the competent authorities.
Any other manufacturing
activities carried out on the site.
Name & address of the site
& any other communication detail, with 24 hrs telephone number.
Type of actual product
manufactured on the site & the information about toxic or hazardous
substances handled,
mentioning the way they are manufactured.
Short description of the site
starting the size, location, immediate environment and other manufacturing
activities on the site.
Number of employees engaged in
the production. Quality control, storage & distribution.
Brief about the outside scientific,
analytical or technical assistance in relation to manufacture & analysis.
Description of the Quality Management System
of the Firm responsible for manufacturing.
Quality policy.
Responsibilities of Quality Assurance.
Elements of QA system like organization
structure, responsibilities, procedures, process specification, test
Methods &other quality related data
collection.
Self – infection or audits by external
organization undertaken.
Review of batch documentation
and release of batch.
Personnel
Requirement:
Organization chart showing the arrangements
for quality assurance, including production and quality control.
Qualification, experience and
responsibilities of the key personnel.
Training arrangement for the
basis and the in – service and maintenance of records.
Health requirement of the
personnel engaged in production.
Personnel hygiene requirements,
including clothing.
Premises and equipment:
Premises
Simple plan or description of
manufacturing area with the indication of scale.
Nature of construction and
finishes.
Brief description of
ventilation systems. More details should be given for critical with potential
risks of airborne
Contamination (schematic
drawings of the system are desirable).
Classification of the room used
for the manufacture of production.
Special areas for the handling
of highly toxic, hazardous and sensitizing materials.
Description of water system
(schematic drawing of the system are desirable) including sanitation.
Maintenance (description of
planned preventive maintenance programmes and recording system).
Equipment
Description of major production
and laboratory equipment.
Maintenance (description of
planned preventative maintenance programmes and recording system).
Qualification and calibration,
including recording system.
Arrangements for computerized
systems validation.
Sanitation
Availability of written
validated specifications and procedures for cleaning manufacturing and
equipment. Change of cleaning agent at frequencies.
Documentation:
Arrangements for the
preparation, revision and distribution of necessary documentation for manufacture of the
Product.
Documentation related to
product quality (e.g. microbiological controls on air and water).
Production:
Brief description on the
existing production operations by means of flow chart specifying important
parameters.
Handling of starting materials,
packing materials, bulk and finished products, including sampling, testing, release
and storage.
Brief description of general policy for
process validation.
In – process checks and records.
Records of key parameters.
Quality Control:
Description of the Quality
Control system and of the activities of the Quality Control Department.
Procedure for the release of
finished products.
Quality control activity like
analytical testing, packing component testing, biological and microbiological
testing.
Role of QC in the arrangements
for the preparation, revision and distribution of documents in particular
those for specification test methods and release criteria.
Contract manufacture and analysis:
Description of the way in which
the GMP compliance of the contract acceptor is assessed.
Distribution, Complaints and Product recall:
Arrangements and recording
system for distribution.
Arrangements for the handing of
market complaints and product recall.
Self inspection:
Short description of the self
inspection system.
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6.0
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REFERENCES
WHO technical series number 823
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7.0
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ANNEXURES
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Annexure No.
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Title of Annexure
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Format No.
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Annexure I
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SPECIMEN FORMAT FOR SMF
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QA/008/F01-01
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8.0
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ABBREVIATIONS
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Abbreviations
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Full Forms
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SOP
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Standard Operating
Procedure
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QA
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Quality Assurance
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GMP
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Good manufacturing
practices
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QC
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Quality Control
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SMF
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Site Master File
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WHO
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World Health Organization
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9.0
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DISTRIBUTION
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Master Copy
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Head Quality Assurance
Department
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Controlled office Copy No. 1
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Head Quality Assurance Deptt.
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10.0
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REVISION
HISTORY
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S.No.
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Revision No.
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Effective
Date
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Reason for
Revision
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Details of
Change
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Authorized
By
(sign
& Date)
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TABLE OF
CONTENTS
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PARTICULARS
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PAGE No.
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Table of Content
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General Information
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Manufacturing Site & Manufacturing Activities.
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Quality Management System /Quality Policy
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Responsibility of Key Personnel
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Qualification & Experience of Technical Staff
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Health requirement, Personnel Hygiene & Training
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Premises and
Ventilation System
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Potable water & Water Purification System
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Effluent Treatment Plant.
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Preventive Programme For Premises
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Plant and Machinery Installed and Preventive
Maintenance
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Qualification and Calibration
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Sanitation
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Documentation
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Policy of Process Validation & Production
Activity Flow.
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Handling of Rejected Materials.
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Quality Control Activity
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Distribution, Complaints and Product Recall
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Self Inspection
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List of Annexure
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Annexure I
SPECIMEN FORMAT FOR SMF
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