GLP

Question 1

When was GLP developed?

Answer 1

1970

Question 2

GLP was developed in response to

Answer 2

Fraudulent scientific safety studies

Question 3

They performed about 35-40% of all US TOXICOLOGY TESTING

Answer 3

Industrial Bio-test Laboratories

Question 4

FDA GLP was
PROPOSED in
FINALIZED in
EFFECTIVE in

Answer 4

1976
1978
1979

Question 5

OECD GLP was developed and published in

Answer 5

1981

Question 6

FDA decision is to introduce a NEW REGULATION to cover the

Answer 6

Non-clinical safety studies

Question 7

GLP promotes

Answer 7

Quality and validity

Question 8

GLP helps scientists obtain results which are

Answer 8

Reliable
Repeatable
Auditable
Recognized

Question 9

GLP is a quality system with ORGANIZATIONAL process and CONDITIONS under which non-clinical health and environmental studies are

Answer 9

Planned
Performed
Monitored
Recorded
Archived
Reporter

Question 10

GLP is a what SYSTEM and MECHANISM

Answer 10

Quality Management System
Regulatory Control Mechanism

Question 11

Quality management is to ensure

Answer 11

Quality
Consistency
Accuracy
Integrity

Question 12

Regulatory Control Mechanism is for

Answer 12

Quality
Safety

Question 13

Institutions should assign ROLES and RESPONSIBILITIES to ensure

Answer 13

Food operational management

Question 14

Is GLP DIRECTLY concerned with the SCIENTIFIC DESIGN of studies?

Answer 14

No

Question 15

ADHERENCE to GLP will REMOVE

Answer 15

Sources of error and uncertainty = overall CREDIBILITY

Question 16

Advantages of GLP

Answer 16

True reflection of results
Preclinical and residue safety
High quality and reliable data
Mutual acceptance
Increase public confidence
Shortens time-to-market

Question 17

Disadvantages of GLP

Answer 17

More manpower
Expensive
Time consuming

Question 18

Why is GLP time consuming

Answer 18

It is a SYSTEMATIC PROCESS that needs approval in every steps = NO SHORTCUT

Question 19

The GLP principles in their REGULATORY SENSE, apply only to studies which

Answer 19

Non-clinical (animals and in vitro)
Data on properties and safety
Submitted to NATIONAL REGISTRATION AUTHORITY for registering or licensing

Question 20

The GLP requirements for non-clinical laboratory studies conducted to EVALUATE DRUG SAFETY over the following classes of studies

Answer 20

Single dose toxicity
Repeated dose toxicity
Reproductive toxicity
Mutagenic potential
Carcinogenic potential
Toxicokinetics
Pharmacodynamic studies
Local tolerance tests

Question 21

Repeated dose toxicity includes

Answer 21

Sub-acute
Chronic

Question 22

Reproductive toxicity includes

Answer 22

Fertility
Embryo-foetal toxicity
Teratogenicity
Peri/post natal toxicity

Question 23

Local tolerance tests include

Answer 23

Photo toxicity
Irritation and sensitisation
Addictive or withdrawal effects

Question 24

5 fundamental points of GDP

Answer 24

Resources
Characterisation
Rules
Results
Quality assurance

Question 25

Management/quality responsibilities Organizational chart Job description Coordination with internal and external agencies

Answer 25

Organization

Question 26

Qualified and competent; skilled Continuing education Well trained

Answer 26

Personnel

Question 27

Approves protocols Ensures QA Checks experimental data accuracy OVERSEES all studies

Answer 27

Study director

Question 28

Suitable size, spacious Adequate degree of SEPARATION of different activities Organized WORKFLOW Well VENTILATED and CLEAN

Answer 28

Facility design

Question 29

SECURE storage and RETRIEVAL if study plans, raw data, final report and specimens.

Answer 29

Archived facilities

Question 30

What does archive facilities SECURE and STORE

Answer 30

Study plans Raw data Final report Specimens

Question 31

Appropriate COLLECTION, STORAGE and DISPOSAL facilities and DECONTAMINATION procedures

Answer 31

Waste disposal

Question 32

Located AWAY from testing laboratories (separate building) SEPARATE AREA for animals, diagnosis, treatment and control of animals

Answer 32

Animal care facilities

Question 33

CONTAMINATION RISK of animal care facilities is reduced by

Answer 33

Barrier system Clean and dirty corridors

Question 34

What to CONSIDER in animal care facilities

Answer 34

Lighting Noise Temperature

Question 35

Documented program to ensure SUITABILITY and CALIBRATION Adequate design and capacity LOGBOOKS for each

Answer 35

Equipment

Question 36

It is done for ACCURACY of measurements

Answer 36

Calibration

Question 37

Test item vs. test system

Answer 37

TI: compound you are investigating TS: experimental protocol

Question 38

Questions for test item vs. test system

Answer 38

TI: WHEN and WHAT part did you get TS: HOW will you administer it

Question 39

CHARACTERISTICS of a test item

Answer 39

Test item identity

Question 40

Test item identity includes

Answer 40

Potency Composition Stability Purity/impurity

Question 41

Formulation and dosing record CHEMICAL ANALYSIS

Answer 41

Test item

Question 42

CHARACTERISATION of plant material

Answer 42

Fresh or dried Climatic condition Plant part Ration of sample to solvent

Question 43

Characterisation choice of vehicle

Answer 43

INTERACTION of the vehicle with the active constituent PH

Question 44

Procurement Quality Acclimatization Animal handling/husbandry

Answer 44

Test system