contented and precise . good laboratory practices is an integral part of an developed and a regulated pharmaceutical market.there are certain qualities to be procured by an analyst to reach the top notch level.

1. GOOD LABORATORY
PRACTICES
_ BY S.KAVYA
B.PHARMACY FINAL YEAR

2. INTRODUCTION
• GLP : QUALITY SYSTEM OF MANAGEMENT FOR RESEARCH LABORATORIES AND
ORGANIZATIONS .
• THEY ENSURE UNIFORMITY , CONSISTENCY ,RELIABILITY ,INTEGRITY AND
ULTIMATELY QUALITY.
• IT PROMOTES INTERNATIONAL ACCEPTANCE FOR TESTS.

3. HISTORY
• IN 70’S FDA BECAME AWARE OF POOR LABORATORY PRACTICES
• FDA DECIDED TO INVESTIGATE 40 TOXICOLOGY LABS
• THEY FINALLY FRAMED “GLP”

4. BASIC ELEMENTS OF GLP
personnel
documents
facility
Test and
control articles

5. GRADING OF AN ANALYSTS
Grade 1 Grade 2 Grade3 Grade4 Grade5
1.Knowledge of
basic chemical
principles,
theories and
laboratory
techniques.
2. Should
capable of
analysing raw
materials
,finished
products.
3.Should strictly
adhere to
laboratory
testing
procedures.
1. Knowledge
required to
operate more
advance
equipments
such as HPTLC
,HPLC,GC ,IR
2. Knowledge of
GLP and CGLP.
3.Should analyse
sample using
well established
and validated
analytical
procedures.
1.Knowledge of
regulatory
policies
,validation
techniques and
criteria for
method
acceptance.
2.Should
supervise the
proficiency of
analyst.
3.Should analyse
sample using
compendial or
monographic
procedures.
1.Knowledge
required to
operate more
advanced
equipments
such as AAS ,
NMR .
2. Knowledge of
statistical
methods for
data evaluation.
3. Should
possess
Isolation ,
purification and
Identification of
1. Good
Administrativ
e qualities.
2. should
conduct
collaborative
studies
including
Audit and
Inspection.
3. Should be
an Expert in
Trouble
shooting and
act as a team
leader.

6. DESIRABLE QUALITIES OF AN ANALYST
APTITUDE and
ALTITUDE of
MIND.
SOUND
KNOWLEDGE ON
CHEMICAL
PRINCIPLES
WORKING
INDEPENDENTLY
INTIATIVE
CREATIVE
ABLE TO
INTERACT
FLEXIBLE and
APPRECIATE
OTHERS WORK.
GOOD UTILITY
OF TIME
PUNCTUAL IN
ALL WAYS
IMBIBING
CONFIDENCE TO
COLLEAGUES
GOOD
COMMUNICATIVE
SKILLS

7. SPECIFICATIONS OF LABORATORY CONTROLS
1.Written specification of raw material
2.It is authorized by the quality
manager.
3.Approval of statutory standards.
4. If no statutory standards are
present the specifications should
contain requirements for identification
,limits for purity potency.
5. Written specification should contain
date of issue .

8. SPECIFICATION OF LABORATORY CONTROLS
Raw materials
1.Name
,internal code
reference.
2.Reference
(pharmacopoe
ial reference )
3.Directions
for sampling
and testing.
4. Storage
conditions .
Containers
1.All containers
and closures
should comply
with
pharmacopoeial
Standards.
2. Cleaning &
sterilization
procedures
should be
mentioned.
3.It should not
reactive
,absorptive and
leach
Finished goods
1.Designated
name of the
product, code
reference
2.Description of
dosage form
3.Qualitative and
quantitative
requirements .
4. Storage
conditions
5. Shelflife
6.
Pharmacopoeial
reference .

9. CENTRAL REGISTRY
1. Reference substances and reference
materials are compiled in central registry
2. Identification number
3. precise description
4. source
5. date of receipt
6. intended use
7. Location of storage
8. Expiry date ,re-test date
9. Periodical maintanence of central registry.
10.The person experienced in
medicinal analysis should maintain
central registry.
11.Periodic analysis of reference
materials is necessary.
12.Information file is kept along with
central register.

10. SAFETY GUIDELINES IN DRUG CONTROL
LABORATORIES1. Each staff
should be
aware of
General and
specific safety
instructions
2. Written
materials,post
er displays
are necessary.
3. Smoking
,eating
,drinking in
the laboratory
is prohibited.
4. Adequate
insulation
,spark
proofing is
5.First aid
materials
6.Containers
should be
labelled
including
“POISON”,
“FLAMMABLE”,
RADIATION .
7.Highly toxic
or carcinogenic
samples should
be handled and
stored
separately to
avoid
contaminants.
8.