Good Laboratory practice (GLP)

Question 1

What solvent was used in the oral ‘elixir of sulfanilamide’ in 1937?

Answer 1

Diethylene glycol (DEG)

DEG was used as a solvent before its harmful effects were recognized.

Question 2

How many people died due to the use of Diethylene glycol (DEG) in 1937?

Answer 2

107 people

Many of the victims were children.

Question 3

What serious health issues can Diethylene glycol (DEG) cause?

Answer 3

Kidney damage or failure

DEG toxicity led to severe health consequences.

Question 4

What legislative response was enacted following the DEG incident?

Answer 4

The Federal Food, Drug and Cosmetic (FD&C) Act of 1938

This act mandated safety proof for products before marketing.

Question 5

What was a significant requirement introduced by the FD&C Act of 1938?

Answer 5

Companies were required to prove that their products are safe before marketing them

This was the first time such a requirement was implemented.

Question 6

What type of testing was emphasized as part of the safety requirements introduced by the FD&C Act?

Answer 6

Animal testing

Animal testing became a critical aspect of proving product safety.

Question 8

What does GLP stand for?

Answer 8

Good Laboratory Practice

GLP is a framework for planning, performing, monitoring, reporting, and archiving laboratory studies.

Question 9

What is the main focus of Good Laboratory Practice?

Answer 9

Quality system for research labs

GLP aims to ensure that laboratory studies are conducted under a set of principles.

Question 10

What does GLP ensure in laboratory studies?

Answer 10

Uniformity, consistency, reliability, reproducibility, and traceable data

These elements are critical for the integrity of laboratory research.

Question 11

What types of studies do GLP-compliant laboratories perform?

Answer 11

Non-clinical and environmental studies

GLP is primarily applied to studies that do not involve clinical trials.

Question 12

Fill in the blank: GLP provides a framework within which laboratory studies are _______.

Answer 12

[planned, performed, monitored, reported and archived]

These are essential components of the GLP framework.

Question 13

True or False: GLP is only applicable to clinical research laboratories.

Answer 13

False

GLP applies to research labs conducting non-clinical and environmental studies.

Question 14

What did the FDA become aware of in the early 1970s?

Answer 14

Poor laboratory practice all over the United States

Question 15

What action did the FDA take regarding toxicology labs in the early 1970s?

Answer 15

Conducted an in-depth investigation on 40 toxicology labs

Question 16

What did the FDA discover during their investigation of toxicology labs?

Answer 16

Fraudulent activities and poor lab practices

Question 17

What is one example of poor lab practices found by the FDA?

Answer 17

Equipment not calibrated to standard form

Question 18

What is another example of poor lab practices discovered by the FDA?

Answer 18

Incorrect/inaccurate accounts of the actual lab study

Question 19

What is a third example of poor lab practices identified by the FDA?

Answer 19

Inadequate test systems (procedure & methods)

Question 20

What is an example of a laboratory that faced investigation due to faulty practices of GLP?

Answer 20

Industrial Bio Test Lab

This lab conducted tests for major companies like Procter and Gamble.

Question 21

What type of products were tested using mice at Industrial Bio Test Lab?

Answer 21

Cosmetics (lotion and deodorants)

The testing aimed to evaluate safety for human use.

Question 22

What was discovered about the mice used in the tests at Industrial Bio Test Lab?

Answer 22

They developed cancer and died

This finding raised serious ethical and safety concerns.

Question 23

What action did Industrial Bio Test Lab take regarding the dead mice?

Answer 23

Threw the dead mice and covered results

They falsely deemed the products safe for human use.

Question 24

True or False: Industrial Bio Test Lab reported accurate results regarding the health of the test mice.

Answer 24

False

The lab hid the negative results to maintain product approval.

Question 25

What prompted the FDA to promulgate the Good Laboratory Practice (GLP)?

Answer 25

Fraud practices and faulty result data submitted to the FDA by toxicology labs and pharmaceutical companies ## Footnote This was a significant issue that led to the establishment of regulations to ensure data integrity.

Question 26

When were the GLP regulations established by the FDA?

Answer 26

December 22, 1978 ## Footnote This date marks the official promulgation of the regulations, which are found in 21 CFR part 58.

Question 27

When did the GLP regulations become effective in the USA?

Answer 27

June 1979 ## Footnote This was the date when the regulations began to be implemented.

Question 28

Did GLP originate in the United States?

Answer 28

Yes, GLP originated in the United States ## Footnote However, it had a significant worldwide impact.

Question 29

What requirement did non-US companies face regarding GLP?

Answer 29

They had to comply with the United States GLP regulations to do business or register their pharmacies in the United States ## Footnote This compliance influenced other countries to adopt similar regulations.

Question 30

What organization was formed in 1961 to stimulate economic progress and world trade?

Answer 30

OECD (Organization for Economic Co-operation and Development) ## Footnote This organization played a role in developing international standards.

Question 31

What did the OECD develop in 1992?

Answer 31

GLP principles that are international standards ## Footnote These principles help ensure consistency and reliability in laboratory practices worldwide.

Question 32

In which countries was GLP first introduced in 1972?

Answer 32

New Zealand and Denmark ## Footnote These countries were among the pioneers in adopting GLP before it spread globally.

Question 33

What does GLP stand for?

Answer 33

Good Laboratory Practice ## Footnote GLP is a quality system of management applicable to research laboratories and organizations.

Question 34

What is the purpose of GLP?

Answer 34

To ensure uniformity, consistency, reliable, and reproducible data on the quality and integrity of chemicals ## Footnote This includes pharmaceuticals and other chemicals.

Question 35

What types of tests are conducted under GLP?

Answer 35

Non-clinical safety tests ## Footnote These tests range from physio-chemical properties to acute and chronic toxicity tests.

Question 36

What is the focus of non-clinical studies under GLP?

Answer 36

Assessment of the safety and efficacy of chemicals ## Footnote This includes evaluation for humans, animals, and the environment.

Question 37

What is included in physical-chemical testing under GLP?

Answer 37

Physical-chemical testing includes assessments of the chemical properties of substances ## Footnote This may encompass solubility, stability, and other relevant characteristics.

Question 38

What types of toxicity studies are conducted under GLP?

Answer 38

Toxicity studies include: * Single dose toxicity * Repeated dose toxicity (sub-acute and chronic) ## Footnote These studies evaluate the harmful effects of substances on organisms.

Question 39

What aspects are evaluated in reproductive toxicity studies?

Answer 39

Reproductive toxicity studies evaluate: * Fertility * Embryo-foetal toxicity and teratogenicity * Peri-/post-natal toxicity ## Footnote These studies assess the impact of substances on reproduction and development.

Question 40

What are mutagenicity studies designed to assess?

Answer 40

Mutagenicity studies are designed to assess the potential of substances to cause genetic mutations ## Footnote These studies help in understanding the risk of cancer or hereditary effects.

Question 41

What do environmental toxicity studies focus on?

Answer 41

Environmental toxicity studies focus on: * Aquatic organisms * Terrestrial organisms ## Footnote These studies evaluate the impact of chemicals on ecosystems.

Question 42

What is the purpose of toxicokinetics studies?

Answer 42

The purpose of toxicokinetics studies is to provide systemic exposure data for toxicity studies ## Footnote These studies help in understanding how substances are absorbed, distributed, metabolized, and excreted.

Question 43

What do pharmacodynamic studies evaluate?

Answer 43

Pharmacodynamic studies evaluate the potential for adverse effects of substances ## Footnote These are often referred to as safety pharmacology studies.

Question 44

What is assessed in studies determining pesticide residues?

Answer 44

Studies determine pesticide residues in: * Food * Animal feedstuffs ## Footnote These studies ensure food safety and compliance with regulations.

Question 45

What do studies on effects on natural ecosystems examine?

Answer 45

Studies on effects on natural ecosystems examine the impact of substances on biodiversity and ecosystem health ## Footnote These studies are crucial for environmental risk assessments.

Question 46

What types of testing are included in analytical and clinical chemistry testing?

Answer 46

Analytical and clinical chemistry testing includes assessments of chemical composition and purity ## Footnote These tests are essential for quality control and regulatory compliance.

Question 47

What are the objectives of GLP?

Answer 47

makes sure data is traceable data submitted is a true reflection of the results obtained in the study achieve international confidence avoid repetition of studies. optimize animal conditions

Question 48

List the GLP principles.

Answer 48

test facility organization and personnel quality assurance program test facilities equipment, reagents and materials test systems test and reference items SOPs performance of study report of results archival- storage of records and reports

Question 48

What role is played by the test facility organization and personnel?

Answer 48

Make sure that a sufficient no. of qualified personnel, appropriate facilities, equipment and materials are available for the timely and proper conduct of study. Personnel involved clearly understand the functions they have to perform and where necessary provide training for these functions. Appropriate and technically valid SOP are established and followed, and approve all original and revised SOPs.

Question 49

What are the study director responsibilities?

Answer 49

has the responsibility for the overall conduct of the study and its final report. approve the study plan and any amendment to the study plan by the dated signature. Ensure the QA personnel have a copy of the study plan. Ensure that the study plan, amendments and SOPs are available to the study personnel. Sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these principles of GLP.

Question 50

What are the principal investigator responsibilities?

Answer 50

primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations.

Question 51

Study personnel responsibilities

Answer 51

All the study personnel are responsible for recording raw data promptly and accurately in compliance with these principles of GLP, and are responsible for their data. They should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study.

Question 52

what are the three types of inspection?

Answer 52

Study-based inspections. (to inspect thoroughly and meticulously a specific test or test method). Facility-based inspections. (that is, to inspect the whole facility whether it meets the GLP requirements,) Process-based inspections (that is, to inspect the process that the laboratory uses to perform a specific activity. )

Question 53

What are the requirements on apparatus, materials, and reagents?

Answer 53

All chemicals and solutions are clearly and currently labeled with the substance name, concentration, date, and name of the individual responsible and indicate identity, expiry, and specific storage instructions.

Question 54

what is the 5s principle in the laboratory?

Answer 54

1.Sort 2.Set in order 3.Shine 4.Standardize 5.Sustain

Question 55

what dooes the 5s system emphasize?

Answer 55

discipline, efficiency, and attention to detail

Question 56

what are the types of test systems?

Answer 56

physical chemical biological

Question 57

what is a requirement or protocol for biological test systems?

Answer 57

should be acclimatized to the test environment for an adequate period before the first administration of the test/reference item. (Sham test for pyrogen test)

Question 58

What tests require the use of a standard?

Answer 58

assay identification purity

Question 59

what happens if standards are not available?

Answer 59

recommendation is to take a lot of your own material, and analyze, certify and use it as the standard.

Question 60

what are SOPs?

Answer 60

Written procedures for a laboratories program. a method of keeping records, reporting, storage, mixing, and retrieval of data.