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Pharmacology Lab > GLP > Flashcards

GLP Flashcards

1
Q

When was GLP developed?

A

1970

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2
Q

GLP was developed in response to

A

Fraudulent scientific safety studies

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3
Q

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

A

Industrial Bio-test Laboratories

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4
Q

FDA GLP was
PROPOSED in
FINALIZED in
EFFECTIVE in

A

1976
1978
1979

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5
Q

OECD GLP was developed and published in

A

1981

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6
Q

FDA decision is to introduce a NEW REGULATION to cover the

A

Non-clinical safety studies

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7
Q

GLP promotes

A

Quality and validity

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8
Q

GLP helps scientists obtain results which are

A

Reliable
Repeatable
Auditable
Recognized

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9
Q

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

A

Planned
Performed
Monitored
Recorded
Archived
Reporter

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10
Q

GLP is a what SYSTEM and MECHANISM

A

Quality Management System
Regulatory Control Mechanism

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11
Q

Quality management is to ensure

A

Quality
Consistency
Accuracy
Integrity

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12
Q

Regulatory Control Mechanism is for

A

Quality
Safety

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13
Q

Institutions should assign ROLES and RESPONSIBILITIES to ensure

A

Food operational management

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14
Q

Is GLP DIRECTLY concerned with the SCIENTIFIC DESIGN of studies?

A

No

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15
Q

ADHERENCE to GLP will REMOVE

A

Sources of error and uncertainty = overall CREDIBILITY

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16
Q

Advantages of GLP

A

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

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17
Q

Disadvantages of GLP

A

More manpower
Expensive
Time consuming

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18
Q

Why is GLP time consuming

A

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

19
Q

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

A

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

20
Q

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

A

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

21
Q

Repeated dose toxicity includes

A

Sub-acute
Chronic

22
Q

Reproductive toxicity includes

A

Fertility
Embryo-foetal toxicity
Teratogenicity
Peri/post natal toxicity

23
Q

Local tolerance tests include

A

Photo toxicity
Irritation and sensitisation
Addictive or withdrawal effects

24
Q

5 fundamental points of GDP

A

Resources
Characterisation
Rules
Results
Quality assurance

25
Q

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

A

Organization

26
Q

Qualified and competent; skilled
Continuing education
Well trained

A

Personnel

27
Q

Approves protocols
Ensures QA
Checks experimental data accuracy
OVERSEES all studies

A

Study director

28
Q

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

A

Facility design

29
Q

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

A

Archived facilities

30
Q

What does archive facilities SECURE and STORE

A

Study plans
Raw data
Final report
Specimens

31
Q

Appropriate COLLECTION, STORAGE and DISPOSAL facilities and DECONTAMINATION procedures

A

Waste disposal

32
Q

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

A

Animal care facilities

33
Q

CONTAMINATION RISK of animal care facilities is reduced by

A

Barrier system
Clean and dirty corridors

34
Q

What to CONSIDER in animal care facilities

A

Lighting
Noise
Temperature

35
Q

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

A

Equipment

36
Q

It is done for ACCURACY of measurements

A

Calibration

37
Q

Test item vs. test system

A

TI: compound you are investigating
TS: experimental protocol

38
Q

Questions for test item vs. test system

A

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

39
Q

CHARACTERISTICS of a test item

A

Test item identity

40
Q

Test item identity includes

A

Potency
Composition
Stability
Purity/impurity

41
Q

Formulation and dosing record
CHEMICAL ANALYSIS

A

Test item

42
Q

CHARACTERISATION of plant material

A

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

43
Q

Characterisation choice of vehicle

A

INTERACTION of the vehicle with the active constituent
PH

44
Q

Procurement
Quality
Acclimatization
Animal handling/husbandry

A

Test system

Pharmacology Lab (2 decks)

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