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Gmp 1

Gmp 1

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Published by j.k.kumar

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Published by: j.k.kumar on Oct 08, 2007
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05/24/2012

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101
© World Health OrganizationWHO Technical Report Series, No. 902, 2002
Annex 8
Quality systems requirements for national goodmanufacturing practice inspectorates
Background
101
1.
Introduction
102
2.
Glossary
102
3.
Administrative structure
103
4.
Terms of reference
104
5.
Organizational structure
104
6.
Inspection personnel
106
7.
Documentation
107
8.
Records
109
9.
Inspection procedures
109
10.
Inspection facilities required
112
11.
Quality manual
113
12.
Confidentiality
114
13.
Publications
115
14.
Appeals
115
15.
Internal audit and periodic review
116
16.
Complaints
117
17.
Recalls
117
References
118
Background
Following the provisional guidelines on the inspection of pharmaceu-tical manufacturers (
1
), the WHO Expert Committee on Speci
ca-tions for Pharmaceutical Preparations acknowledged that additionalguidelines concerning national inspectorates would be of value instrengthening the implementation of good manufacturing practices(GMP) (
 2
) and enhancing mutual recognition among inspectorates.A trend has recently become apparent in WHO Member Statesfor non-commercial institutions, such as certi
cation bodies, testing
 
102
laboratories, etc., to introduce quality systems principles in their inter-nal operations. The same principles are also being applied by govern-mental pharmaceutical inspectorates and drug control laboratories.The Pharmaceutical Inspection Convention (PIC) has published adocument (
 3
), with the objective of adapting the standards of theInternational Organization for Standardization (ISO) of the 9000series and related norms (
4
 –
8
) to the activities of the GMPinspectorates of Member States. It is based on European StandardEN 45012,
General criteria for certi
 fi
cation bodies operating quality systems certi
 fi
cation
(
9
), but has been modi
ed for this particularpurpose.
1.
Introduction
These requirements are applicable to quality systems for the opera-tion of inspection services within competent authorities concernedwith GMP inspections. It is intended that each inspection serviceshould use these requirements as the basis for developing its ownquality system.The establishment and operation of a quality system is an essentialelement in the mutual recognition of national GMP inspections. Thewillingness to accept national inspections is signi
cantly enhancedwhen it is known that the GMP inspectorate of the competent author-ity follows uniform procedures incorporating quality system prin-ciples. The quality system should include all the activities involved inthe inspection.
2.
Glossary
authorized person 
A person (among key personnel of a manufacturing establishment)responsible for the release of batches of 
nished products for sale(
10
).
quality audit 
An examination and assessment of all or part of a quality system withthe speci
c purpose of improving it. A quality audit is usually con-ducted by outside or independent specialists or a team designated bythe management for this purpose. Such audits may also be extendedto suppliers and contractors (
 2
).
quality manual 
A handbook that describes the various elements of the system forassuring the quality of the test results generated by a laboratory (seesection 11).
 
103
quality system 
An appropriate infrastructure, encompassing the organizationalstructure, procedures, processes and resources necessary to ensureadequate con
dence that a product (or service) will satisfy givenrequirements for quality (
 2
).
standard operating procedure (SOP) 
An authorized written procedure giving instructions for performingoperations not necessarily speci
c to a given product or material butof a more general nature (e.g. equipment operation, maintenance andcleaning; validation; cleaning of premises and environmental control;sampling and inspection). Certain SOPs may be used to supplementproduct-speci
c master and batch production documentation (
 2
).
3.
Administrative structure
3.1The structure, membership and operation of the GMP inspec-torate should be such that impartiality is safeguarded.3.2The national inspection services are responsible for ensuring thatthe requirements of the relevant national legislation are satis
ed.3.3All personnel employed or used by the GMP inspectorate, includ-ing outside inspectors or subcontracted personnel, should not besubject to any commercial,
nancial or other pressures which mightaffect their judgement. They should not be under the control of pharmaceutical manufacturers, and must be assessed and licensed.3.4The system for obtaining fees should not improperly in
uence theinspection procedure.
Recommended procedure 
The administrative structure, membership, operation and legal statusof the GMP inspectorate should be described in the quality manual(see section 11).The quality manual should show how all personnel working for theGMP inspectorate, including subcontracted staff or advisers, andpersons serving on committees providing advice, can maintain theirimpartiality. The GMP inspectorate should ensure that such persons:(a)are not subject to any commercial,
nancial or other pressureswhich might in
uence their judgement;(b)are not improperly in
uenced in their inspection of pharmaceuti-cal manufacturers or persons assessed;(c)have not been involved in the design or maintenance of inspectedfacilities by way of any consultancy service or commercialarrangement.

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