OPPI Guidelines On Good Laboratory Practices (GLP)
OPPI Guidelines On Good Laboratory Practices (GLP)
OPPI Guidelines On Good Laboratory Practices (GLP)
ACKNOWLEDGEMENTS
Associated Capsules
VICE-CHAIRMAN
R. Raghunandanan
GlaxoSmithKline
MEMBERS:
G.K. Nair
Dr. K.R.P. Shenoy
Satish L. Rajkondawar
Ram Parthasarathy
Dr. U.C. Shetty
Pramod Pimplikar
Dr. Bomi M. Gagrat
Ms. Shweta Purandare
Dr. A.G. Seshadrinathan
V.N. Phatak
Dr. Amit Bhadra
Associated Capsules
AstraZeneca
Sanofi Aventis Group
Baxter
Johnson & Johnson
Merck
Pfizer
Procter & Gamble
Raptakos Brett & Co.
Solvay
Wyeth
CONTENTS
Sr. No.
Page No.
1.
Objective
2.
Scope
3.
Personnel
4.
Facilities
5.
Documentation
6.
Calibration
7.
10
8.
12
9.
Change Control
14
10.
14
11.
Safety
15
12.
Training
17
13.
Quality Audit
19
14.
Management Review
20
15.
Definitions
15.1
15.2
15.3
15.4
15.5
15.6
15.7
22
16.
GLP
Test Facility
Test Facility Manager
Study Plan / Test Method
Raw Data
Standard Operating Procedures (SOP)
Quality Assurance Program
Bibliography
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OPPI
GOOD LABORATORY PRACTICES (GLP)
GUIDELINES
1. OBJECTIVE
Compliance with GLP is a regulatory / legal requirement for the acceptance
of certain studies, undertaken by facilities, to be submitted to Regulatory /
Health Authorities, for risk assessment in Health & Environmental Safety.
For example in UK the Good Laboratory Practice Monitoring Authority
(GLPMA) enforces compliance. The GLP Regulations require that any test
facility that conducts, intends to conduct a regulatory study must be a
member, or prospective member, of the UK GLP Compliance programme.
However there are test facilities, typically as part of a manufacturing
organization, that conduct studies (Tests) which are not regulatory
studies. This document is intended for such facilities. Besides this, in the
arena of Life Sciences, whether in Research or Development or
Manufacture, a good testing Laboratory is a must for building confidence
that the basis of GMP and product assessment is logically and scientifically
correct. However the various branches of Life Sciences need such specific
testing facilities from recombinant DNA testing to Pharmacovigilence that it
will not be possible to cover all such esoteric testing facilities. This document
therefore provides the basic requirements in the running of a general testing
Laboratory in terms of good practices. The objective is to facilitate the
2. SCOPE
This document is designed to facilitate the proper application and
interpretation of the GLP principles for the Organization and for the
Management of a Quality Control Laboratory and to provide guidance for
the appropriate application of GLP principles to testing. This guidance
document is organized in such a way as to provide easy reference to the
GLP principles by following the sequence of the different parts of these GLP
principles.
3. PERSONNEL
The Test Facility must have adequate personnel with the required
qualification, experience and training (and Approval from regulatory
authorities wherever needed) to carry out the assigned functions in a timely
manner according to the principles of GLP.
A Job Description of every category / level of personnel in the Test Facility
must be maintained. This must cover every individual engaged in testing /
analyzing or supervising the analysis. The Job Description must also specify
the limits of authority at each level / category.
The training record for every individual cross-referenced with the Job
description and Departmental training including Material Safety Data sheet
must be available.
The Test Facility Manager must have sufficient educational background,
experience, training and authority to ensure that the Principles of GLP are
complied with, in the test facility.
The Test Facility Manager will ensure that the personnel clearly understand
the functions they are to perform and, where necessary, provide training for
these functions. The Indian Drugs & Cosmetics Act and Rules there under
requires that each area of operations in the Laboratory has an approved
person (competent technical staff) to conduct the tests and /or sign off the
documentation.
4. FACILITIES
The test facility should ideally be situated with direct access to personnel
working in them, without the need to enter through the manufacturing area,
and should be separated from manufacturing areas. This is particularly
important for laboratories involved in the control of biologicals,
microbiologicals and radioisotopes, which should also be separated from
each other. Steps should be taken in order to prevent the entry of
unauthorized personnel. The area must not be used as a right of way by
personnel who do not work in them. Laboratory personnel, however, must
Control samples or reference samples also will need a separate room which
is equipped with temperature and humidity control capable of achieving
the same storage conditions as stated on the labels of the materials being
tested. Proper consideration should be given to ventilation requirements of
the areas depending on the activities carried out therein e.g. extraction,
handling of fuming chemicals, organic solvents, distillation involving
heating etc.
Personal protective equipment should be worn by personnel in the
laboratory (see chapter on Safety). Ideally a distinctive overall or Lab-coat
is advisable for laboratory personnel.
If part or all of the testing is contracted out and a contract testing laboratory
is used, this should be audited and approved based on compliance with
GLP. A technical agreement must be in place between the contract giver
and the contract acceptor with a system in place to provide updated
authorized analytical methods and specifications for the analysis involved.
A change control system must also be in place with the contract testing
laboratory.
5. DOCUMENTATION
The availability of a complete set of SOPs necessary to govern all the
pertinent activities and procedures in the test facility is an absolute
prerequisite. They define how to carry out protocol specific activities. They
b.
c.
d.
e.
f.
g.
Calibration management.
h.
i.
j.
k.
l.
m.
n.
There must be a SOP in place in the laboratory for glassware cleaning & it
should be based on glassware washing efficiency both related to chemical
labs & micro labs. Sensitive items like cells for photometry readings must
have cleaning procedures that demonstrate adequate cleaning.
All documents used should be reviewed, approved, authorized prior to use.
In case of exclusive use of the electronic media, the software and processes
used should be validated and suitable measures put in place to ensure
password controls.
Documents should be periodically reviewed and where necessary, revised
to ensure continuing suitability. Invalid or superseded documents must be
promptly removed or otherwise assured against unintended use. Changes
to documents should be reviewed and approved by the same function that
performed the original review.
Procedures should be established to describe how changes in documents in
computerized systems can be made and controlled. Additionally, clear-cut
procedures must be evolved for storage, distribution, retrieval and
destruction of documents.
Provision must be made to retain raw data, SOPs, documents, final reports
for a predetermined period. There should be archives for orderly storage
and expeditious retrieval. Conditions of storage should minimize
deterioration. Persons responsible for archiving must be identified and only
authorized persons must enter the archives.
Raw data should be recorded on duly controlled raw data sheets or prepaginated authorized logbooks. It should be verified independently by
another competent person. The raw data including the automated
instrument printouts should be immediately signed and dated by the
analyst performing the test. The data stored on temporary storage media
(e.g. thermal paper) should be transferred to a robust storage media (e.g.
photocopy or scan of the print out) and duly authorized establishing
traceability to the original raw data. Data should be recorded, wherever
possible, so as to facilitate trending.
Tests performed must be recorded and the records should include at least
the following data:
i.
ii.
iii.
iv.
v.
Date of testing.
vi.
vii.
viii.
6. CALIBRATION
All test and measuring equipment are likely to influence the test results
directly or indirectly and must be subject to calibration.
The frequency of calibration depends on the instrument, the
recommendation from manufacturers, laboratory experience and extent of
use. Procedures employed for calibration must be clearly written down and
test report must conclude with a statement of status. In case of nonconformity, the report must indicate corrective and preventive action.
All the test instruments and equipment must have a unique identification
number that should be linked to analytical raw data, calibration reports and
10
Laboratory Error
11
the significance of the result when making decisions about the material or
product under test.
Under certain circumstances there may be justification for not following the
above procedure when OOS or atypical result is obtained. Examples of
such situations include, but are not limited to:
OOS supported by results for other tests like low assay with
high result for impurity content.
12
Range
Robustness
Bias
Precision
Limit of detection
Limit of quantification
13
9. CHANGE CONTROL
All changes in equipment, test environment, test method, services, systems
or location that may affect reproducibility, accuracy or standards must be
formally requested, documented and accepted. The likely impact of the
change should be evaluated and the change control procedure should
ensure that sufficient supporting data are generated to demonstrate that
change does not affect the end result or the in-house or registered
specifications.
14
11. SAFETY
People who work in scientific laboratories are exposed to many kinds of
hazards. This can be said of most workplaces; in some, the hazards are well
recognized (those of ordinary fire, for example) and the precautions to be
taken are obvious. Laboratories, however, involve a greater variety of
possible hazards than do most workplaces, and some of those hazards call
15
16
12. TRAINING
Test Facility management must provide training for all personnel whose
duties involve the conducting of tests and analysis. Training should also be
provided to other personnel whose activities could affect the quality of
testing. Besides the basic training on the theory and practice of GLP, newly
17
18
b.
c.
19
QA SOP :
i.
ii.
Facility-based inspection
iii.
Process-based inspection
d.
e.
f.
20
21
15. DEFINITIONS
15.1 GLP :
Good Laboratory Practice is concerned with the organizational processes
and the conditions under which laboratory tests are planned, performed,
monitored, recorded, archived and reported. Adherence by test facilities to
the principles of GLP ensures proper planning of tests and the provision of
adequate means to carry them out. It facilitates the proper conduct of tests,
promotes their full and accurate reporting and provides means whereby the
validity and integrity of the tests and analytical data can be verified. It also
facilitates an audit trail of the products manufactured.
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BIBLIOGRAPHY
1.
2.
3.
4.
5.
6.
7.
8.
9.
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About OPPI
OPPI is an organisation of pharmaceutical manufacturers established in 1965.
Its membership consists of Research based International and large Indian
pharmaceutical companies.
OPPI members account for a substantial share of the industry's total
investment, export and R&D. The market share of its Member-Firms in total
Pharmaceuticals Market in India is over 60%.
OPPI is not only an industry association but also a scientific and professional
body. It organises national and international seminars and workshops relating
to key issues of the pharmaceutical industry and healthcare. It supports
scientific research by professional and academic institutes. It also brings out
technical publications, like Quality Assurance Guide and Environment, Health
& Safety Guide, Pharmaceutical Compendium, Research report on
outsourcing opportunities, Model Guidelines etc.
OPPI members adhere to the Code of Pharmaceutical Marketing Practices of
International Federation of Pharmaceutical Manufacturers Associations
(IFPMA). OPPI has developed operational guidelines for its members for
interpretation and implementation of this Code of Ethical Marketing Practices.
OPPI is also a member of the WorldSelf-Medication Industry (WSMI), France
and has developed code of ethics for advertisement of drugs.
OPPI identifies itself with the country's national health objectives and
encourages its members to make substantial contributions to social concerns. It
also co-ordinates its Members' efforts in national calamities like epidemics,
floods, earthquakes and cyclone.
OPPI also assists other scientific and educational programmes besides having
its own on-going programmes of health education and supports the country's
national objectives of health improvement.
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