Good Laboratory Practices components of GLP CPCSEA guidelines of GLP

1. GOOD LABORATORY PRACTICES
NOIDA INSTITUTE OF ENGINEERING AND
TECHNOLOGY
(PHARMACY INSTITUTE)
Guided by:-
Dr. Saumya Das
Professor (H.O.D, Pharmacology)
NIET (Pharmacy Institute)
Presented by:-
Sandhya Singh
M. Pharma (Pharmacology)
SEM- 1

2. GOOD LABORATORY PRACTICES
 Good laboratory practices (GLP) is an essential requirements of all modern testing
facilities. It embodies a set of principles that provide a framework within which laboratory
studies are planned, performed, monitored, recorded, reported and archived. In order to
promote such principles International Conference on Harmonization (ICH), the
Organization for Economic Cooperation and Development (OECD) have developed
certain test guidelines and principles of GLP.
 GLP provides an assurance to regulatory authorities that the data submitted are a true
reflection of the results obtained during the study and can, therefore, be relied upon
when making risk/safety assessment. GLP are a useful set of standards for any research
laboratory wishing to standardize procedures and verify the reliability of the data
produced. This is an issue of increasing importance to research sponsors. In 1981, OECD
Council recommended that all the member countries apply these guidelines in the testing
of the chemicals and the data generated in accordance with the OECD test guidelines and
the OECD principles of GLP shall be accepted by all the member countries .

3. Components of GOOD LABORATORY PRACTICES studies
1.Standard Operating Procedures GLP is implemented through standard operating procedures (SOPs) that describe the
processes through which specific tasks are achieved and the role and responsibilities for personnel involved in the study.
Operating SOPS are reviewed at regular intervals and the version tracked by effective date and version number..

4. Contd…
2. Study director For each nonclinical laboratory study, a scientist or other
professional of appropriate education, training and experience, or combination
thereof, shall be identified as the study director. The study director has overall
responsibility for the technical conduct of the study, as well as for the
interpretation, analysis, documentation and reporting of the results and
represent the single point of the study conduct.
3. Personnel Each individual engaged in the conduct of or responsible for a
nonclinical laboratory study shall have education, training, experience to enable
that individual to perform the assigned functions. Each testing facility shall
maintain a current summary of training and experience and job description for
each individual engaged in study. Maintenance of health records of individuals
should be there and the personnel engaged in a nonclinical study shall wear
clothing appropriate for the duties they perform.

5. Contd..
 4. Master schedule During any GLP study, master schedule
is prepared. At the time of protocol development, the study
director is to propose to the management the approximate
time frame of the study. This requires that the protocol
contain the pro- posed starting and completion date of the
study. Suitable identification can be the date of first dosing
of the test system to the date of last dosing, the date of
allocation of the test system to the experimental units to the
date of necropsy.
 5.Study protocol Each study shall have an approved written
protocol that clearly indicates the objectives and all methods
for the conduct of the study. It should contain:

6. Contd…
 (a) A description of the title and statement of purpose of the
study. (b) Identification of the test and control articles by
name, chemical abstract number or code number.
 (c) The name of the sponsor and the name and address of
the testing facility at which study is being conducted.
 (d) The number, body weight range, sex, source of supply.
Species strain, substrain and age of the test system.
 (e) The procedure for "identification" of the test system.
 (f) A description of the experimental design, including the
methods for control of bias.

7. Contd..
 (g) A description of diet used in the study as well as solvents and
other materials to be used and the specifications for acceptance
levels of contaminants if present.
 (h) Each dosage level, expressed in mg/kg or any other appropriate
units of the test or control article to be administered and the method
and frequency of administration.
 (i) The type and frequency of tests, analyses and measurementsto be
made.
 (j) The records to be maintained.
 (k) The date of approval of the protocol by the sponsor and the
dated signature of the study director.
 (l) A statement of the proposed statistical methods to be used.

8. Contd…
 6. Testing facility Each testing facility shall be of suitable
size and constructions to facilitate the proper conduct of the
nonclinical laboratory studies.
 7. Recording of results All data generated during the
conduct of a nonclinical laboratory study except that those
are generated by automated data collection systems, shall be
recorded directly, promptly and legibly. All data entries shall
be dated on the date of entry and signed or initialed by the
person entering the data. Any change in the entries shall be
made so as not to obscure the original entry, shall indicate
the reason for such change and shall be dated and signed or
identified at the time of the change.

9. Contd..
 10. Archiving of the records Raw data and specimens
pertaining to a nonclinical laboratory study and required to
be made by this part shall be retained in the archive for
whichever the period is shortest:
 (a) A period of at least two years following the date on which
an application for a research or marketing permit, in support
of which the results of nonclinical laboratory study were
submitted and is approved by the Food and Drug
Administration (regulatory authority).
 (b) A period of at least 5 years following the date on which
the results of the nonclinical laboratory study are submitted
to the Food and Drug administration in support of an
application for research or marketing permit.

10. CPCSEA Guidelines of GLP
 Goal-promote humane care of animals used in biomedical an
behavioral research, enhance well-being and promote
advancement of scientific research Veterinary care
 • Animal procurement - only from approved breeders
Quarantine, Stabilization, and Separation (Small animals
1week to 1 month, Large animals-up to 6 weeks in case of
dogs, monkeys)Surveillance, Diagnosis, treatment and
Control of diseases (Zoonotic diseases)
 • Animal care and technically qualified and trained personnel
Personal hygiene Personally Protective Equipment (PPE),
Shower, Change of uniform, footwear

11. CPCSEA Guidelines of GLP
 • Functional areas Receive, Quarantine, Isolate, Separation of species.
 • Receiving and storage areas for bedding, feed bags, showers, sinks,
washing area, autoclave and area for storage of wastes until disposal
 • Physical facilities Building materials (durable, moisture-resistant, fire-
resistance, vermin/pest resistant), Corridor (clean), Utilities (Drains, water
lines, electrical connections)

12. CPCSEA Guidelines of GLP
 Feed palatable, non-contaminated, and nutritionally
adequate daily unless the experimental protocol requires
otherwise, should be food kept easily accessible and avoid
contamination with waste Bedding should be absorbent, free
from toxic chemicals or other substances that cause
irritation, injure animals (changing bedding twice a week or
whenever necessary)
 • Water easily accessible (fresh, potable, uncontaminated
drinking water sipper bottles)Sanitation and cleanliness-
disinfection and washing of cages and disposal of waste
(incineration, autoclaving, shedding, environmental friendly)

13. References
 Kulkarni S.K., “Handbook of Experimental
Pharmacology”, Vallabh Prakashan, 4th edition, page no.
35, 36,and 37 .

14. Thank you