1. Components of a non Clinical GLP Study
Nonclinical laboratory study
Means in vivo or in vitro experiments in which test
articles are studied Prospectively in test system under
laboratory condition to determine their Safety.
Test articles
Mean any food additives, colour additives drugs ,
biological product electronic prodical medical devices for
human use.
2. Standard operating procedures (sop)
Good laboratory practice is implemented through
standard operating procedures (SOPs) that describe
the processess through which specific task are achieved.
operating SOPs are reviewed at regular intervals and
the version tracked by effective date and version number.
Study director
For each nonclinical laboratory study a scientist or other
professionals of appropriate education training and experience
or combination there of 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.
4. 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 assigenal functions.
Study Protocol
Each study shall have an
approved written protocol that
clearly indicates.
5. Objectives and all methods for the conduct
A description of the title and statement of purpose of
the study.
Identification of the test and control articles by
name chemical abstract number or code number.
The name of the sponsor and the name and address of
the testing facility at Which study is being conducted.
The number,body weight,range,sex,source of
supply species strain,Substrain and age of the
test system .
The procedure for identification of the test system.
6. A description of the experimental design including
the methods for control of bias.
A description of diet used in the study as wall as
solvents and other materials tone used and the
specification for aceptone levels of contaminants if present.
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.
The type and frequency of the test analysis
and measurement to be mode
7. The records to be maintained.
The date of approval of protocol by the sponsor and
the dated signature of the study director.
A statement of the proposed statistical method to
be used .
8. Testing facility
Each testing facility shall be of suitable size and
construction to facilitate the proper conduct of the
non clinical laboratory studies.
Recording of result
All data generated by during the day
conduct of a non clinical laboratory study
are generated by all to mated data
collection system shall be recorded directly
all data enteries.
9. Shall be'dated on the date at entry and signed and
initialed by the person entong the data
Any change in entony shall mode so as not too bserve
the original entn at the time of the change..
Archiving of the records
A Period of at least two years following the
date on which an application for a research
in support of which the results of non
clinical laboratory study were submitted and
is approved by food and drug administration.
10. A Period of at least sqear following
the date on which the results of the fool and
drug administration in support of of
on application for research of marketing
permit.
