Glp guidelines in_qc_laboratory_as_per_ich

PRESENTED BY
ANUSHA .B
Y15MPH431
DEPT . OF PHARMACETICAL
ANALYSIS

 INTRODUCTION
 WHAT IS GLP ?
 WHY IS GLP NEDDED?
 OBJECTIVES OF GLP
 ELEMENTS OF GLP
 IMPORTANCE AND FUNCTION
 CONCLUSION
 REFERENCE

• The term GLP was first used in New Zealand in 1972.
• In 1981 an organization named OECD (organization for
economic co-operation and development ) produced GLP
principles that are international standard.
Good laboratory practice or GLP specifically refers to a
quality system of management controls for research
laboratories and organizations to try to ensure the
uniformity, consistency, reliability, reproducibility, quality

Good Laboratory Practices(GLP) is
a quality system concerned with
the organizational process and the
conditions under which non-clinical
health and environmental safety
studies are planned, performed,
monitored, recorded, archived and
reported.

The purpose of GLP
The principle of Good
laboratory practice (GLP) :
To promote the
development of quality and
validity of test data used for
determining the safety of
chemicals,
Pharmaceuticals,
Food , Cosmetics etc.

Reason behind GLP creation
In the 1970s because of concerns about the validity of non-
clinical safety data submitted to the Food and Drug
Administration (FDA) in the context of New Drug Applications
(NDA).
The inspection of studies and test facilities revealed
instances of inadequate planning and incompetent execution
of studies, insufficient documentation of methods and results,
and even cases of fraud.

These deficiencies were made public in the Kennedy-
Hearings of the US Congress, and the political outcome of
these hearings led to the FDA’s publication of Proposed
Regulations on GLP in 1976, with establishment of the Final
Rule in June 1979 (21 CFR 58.
For example, replacing animals which had died during a study
with new ones (without documenting this fact).
Deleting gross necropsy observations changing raw data in
order to “fit the result tables” in the final report.

FAMOUS EXAMPLE
 The name of the Lab was Industrial
Bio Test. This was a big lab that ran
tests for big companies such as Procter
and Gamble.
 One of the labs that went under such an
investigation made headline news.
 It was discovered that mice that they
had used to test lotion and deodorants had
developed cancer and died

 Industrial Bio Test lab threw the dead mice and
covered results deeming the products good for human
use.
 Those involved in production, distribution and sales for
the IBT lab eventually served jail time.

 GLP makes sure that the data submitted are a true reflection
of the results that are obtained during the study.
 GLP also makes sure that data is traceable.
 Promotes international acceptance
OBJECTIVES OF GLP

GMP vs. GLP
Samples Laboratory Processes Results of
Analysis
Good Laboratory Practices
Raw Materials Packaging
Materials
Manufacturing Processes
Finished
Product of
Standard
Quality
Good Manufacturing
Practices

MANAGEMENT
QUALITY
ASSURANCE
UNIT
INSPECTION &
TEST UNIT
HEAD TESTING
LABORTATORY
SIMPLEST ORGANIZATION IN AN
APPROVED TESTING LABORATORY

GLP stresses the importance of the following main points:
1. Resources: Organisation, personnel, facilities and equipment;
2. Characterisation: Test items and test systems;
3. Rules: Protocols, standard operating procedures (SOPs);
4. Results: Raw data, final report and archives;
5. Quality Assurance: Independent monitoring of research processes

Basic elements in GLP
• Documents
 Standard Operating
 Protocols
 Reports
 Archiving
• Test and Control Articles
 Characterization
 Handling
 Storage
• Facility
 Laboratory infrastructure.
 Animal care
 Equipment
 Reagents
 Organization
personnel
 Management
 Study director
 Quality Assurance

ORGANISATION
GLP regulations require clear definitions of the structure of the
research organisation and the responsibilities of the research
personnel.
This means that the organisational chart should reflect the
reality of the institution and should be kept up to date.
Organisational charts and job descriptions give an immediate
idea of the way in which the laboratory functions and the
relationships between the different departments and posts.

personnel
• Qualification of personnel:
The assumptions is that in order to conduct GLP studies with
right quality a couple of things are important;
1) There should be sufficient .
2) The personnel should be qualified.
Should have the Knowledge of the GLP principles.

• Facility management:
Responsibilities of facility management is well defined. They
designate a study director, as well as assure quality assurance
unit is available, test and control articles are characterized.
• Study director:
He has overall responsibilities for technical conduct safety
studies, as well as interpretation, analysis, documentation and
reporting of results.

Quality Assurance unit
QA must be independent of the
operational conduct of the studies, and
functions as a “witness” to the whole
preclinical research process.
It is responsible for monitoring each study
to assure management that facilities,
equipment, personnel, methods, practices,
records, controls, SOPs, final reports (for
data integrity), and archives are in
conformance with the GLP/GALP

Maintenance & Calibration of Equipment
Equipment shall be adequately inspected, cleaned
& maintained.
In a Quality Control lab, all equipment and
instruments which are directly or indirectly used
for measurement are to be calibrated periodically.

Facility
The facilities should be spacious enough to avoid problems
such as overcrowding, cross contamination or confusion between projects.
Utilities (water, electricity etc.) must be adequate and stable.
Laboratory infrastructure.
General Chemical Laboratory
The specific requirements are:
Well ventilated, lighted and preferably air conditioned to
maintain a temperature of 27 ± 10C.

Instrument Room:
The specific requirements are:
 Temperature : 25 ± 10C
 Relative humidity : 45 ± 5%.
 Constant supply of Electricity
 No vibrational disturbances.
 Separate room for housing semi-micro & microbalances.

All equipment should be suitable for its intended use, and it should be properly
calibrated and maintained to ensure reliable and accurate performance.
REAGENTS
EQUIPMENT
Purchasing and testing should be handled
by a quality assurance program.
Chemicals, reagent and solutions should be labeled
to indicate identity, expiry and specific storage
instructions.
Deteriorated or outdated reagents and solutions
shall not be used.
Include Date opened

DOCUMENTATION
Results of original measurements, observations, and activities
associated with the study which may be needed to verify and
evaluate the study.
Which will provide a picture of what actually happened during the
course of an activity…
Examples are: Raw Data in Laboratory Notebook, Logbook,
Forms, Project Binder/File,
Paper Printout, Electronic Format,
All type of records…

WHAT ARE THE REQUIREMENTS OF DOCUMENTATION?
Therefore the document should show:
What was done…
How it was done…
When the work was performed…
Who performed the work…

DOCUMENTATION TYPE…
Handwritten Documentation
Entry Into Electronic System
Copying Raw Data
Electronic Data Capture

Standard Operating Procedures
(SOP)
 Written procedures for a laboratories program.
 They define how to carry out protocol-specified activities.
 Most often written in a chronological listing of action steps.
 They are written to explain how the procedures are suppose to
work
 Routine inspection, cleaning, maintenance, testing and
calibration.
 Actions to be taken in response to equipment failure.
 Keeping records, reporting, storage, mixing, and retrieval of
data

TRAINING AND
ANALYST CERTIFICATION
All laboratory personnel (managers, supervisory staffs, analysts,
technicians, helpers and others) should have regular training and
updated
Some acceptable proof of satisfactory training and/or competence
with specific laboratory procedures must be established for each
analyst.
Qualification can come from education, experience or additional
trainings, but it should be documented

Safety
In the Quality Control Laboratory, one has to handle a no of
hazardous, poisonous and inflammable chemicals and also pathogenic
organisms.
Hence the adoption of proper safety measure and use of safety
devices are of paramount importance.
The use of mask, gloves, face shields, aprons, gumboots etc. should be
made compulsory in the handling of corrosive chemicals.
There should be adequate fire fighting arrangements in the
laboratory and personnel should be given proper training for fire
fighting.

Benefits of good laboratory practices.
It will give better image of company as a Quality producer in
Global market.
Provide guideline for doing testing and measurement in detail.
Studies done under GLP are definitely more acceptable to Regulatory
bodies.

1)Good house-keeping,
(2) Quality Manual/Documentation,
(3) Quality Policy,
(4) Method Validation,
(5) Instrumental Validation,
(6) System Suitability Tests,
(7) Calibration of Equipment/Instruments/
Calibration Schedules/Traceability,
A General Checklist for GLP Implementation
8) Equipment Log Books,
(9) Standard Analytical Reference Samples and
their Traceability(All related
Certificates/Documentation),
(10) Archives for Samples and Documents,
(11) Specifications for the products investigated

12) Good Vendor Development,
(13) Study Director for Projects,
(14) Statistical Evaluations,
15) Staff proficiency, Health and Safety,
(16) Procedures for Receiving, Dealing and
Disposing Samples,
(17) Environmental monitoring in working
18) Effluent Treatment Monitoring and
Control,
Checklist

(19) Participation in Proficiency Testing Programs,
(20) Internal Audits/Checklists,
(21) Management Review Meetings,
(22) Official Audits/Surveillance Audits,
(23) Customer Complaints—Procedures to deal with them and
Finding Solutions,
(24) Validation of Computer Systems and Software
25) Continuous Performance
Assessment of QA Group,
(26) Raw Data
Collection/Traceability of Data
Checklist

27) Continuous upgradation of knowledge of all Personnel
through Systematic Training Programs,
(28) Material Safety Data Sheets –Toxicity Information
Antidotes for all Dangerous/Hazardous Chemicals,
(29) First Aid Facilities,
(30) Assignment of Clear and Unambiguous
Responsibilities to Various Officers/Personnel,
(31)Standard Operating Procedures,
(32) Sampling Procedures,
Checklist

GLP Certification process
Application
Inspection
Report Submission
Certification
The test facilities/ laboratories have to apply in the
prescribed application form
A pre-inspection of the laboratory is carried
out by the GLP inspectors, followed by a final
inspection.
The report, prepared by the inspection
team, is put to the Technical Committee
for recommendation to Chairman,
NGCMA
•GLP-compliance Certification
(valid for a 3 years)

GLP Application form & certificate

• GLP is an FDA regulation which is accepted and approved as international standards
by OECD
To avoid the fraud activities of
the testing laboratories for
pesticides, pharmaceuticals,
food additives, dyes
To save the
human and
environmental
health
Also erect good
international trade and
establish good
relationship among the
countries
GLP compliance is monitored in India by NGCMA since 2002.

CONCLUSION
In conclusion one must realize that
in the pharmaceutical industry
there is no margin for error and
one must follow good practices in
the laboratory to generate
accurate, precise and reliable data.

BIBLOGRAPHY:
 Pharmaceutical Quality Assurance And Management by
K.P.Bhusari p.g.no:105-112
 Drug Regulatory Affairs by Sai Kishore p.g.no:292-301
 Hand book of good laboratory practices by WHO

Glp guidelines in_qc_laboratory_as_per_ich

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Glp guidelines in_qc_laboratory_as_per_ich