Good Laboratory practice (GLP) Flashcards
To study and learn everything related to GLP
What solvent was used in the oral ‘elixir of sulfanilamide’ in 1937?
Diethylene glycol (DEG)
DEG was used as a solvent before its harmful effects were recognized.
How many people died due to the use of Diethylene glycol (DEG) in 1937?
107 people
Many of the victims were children.
What serious health issues can Diethylene glycol (DEG) cause?
Kidney damage or failure
DEG toxicity led to severe health consequences.
What legislative response was enacted following the DEG incident?
The Federal Food, Drug and Cosmetic (FD&C) Act of 1938
This act mandated safety proof for products before marketing.
What was a significant requirement introduced by the FD&C Act of 1938?
Companies were required to prove that their products are safe before marketing them
This was the first time such a requirement was implemented.
What type of testing was emphasized as part of the safety requirements introduced by the FD&C Act?
Animal testing
Animal testing became a critical aspect of proving product safety.
What does GLP stand for?
Good Laboratory Practice
GLP is a framework for planning, performing, monitoring, reporting, and archiving laboratory studies.
What is the main focus of Good Laboratory Practice?
Quality system for research labs
GLP aims to ensure that laboratory studies are conducted under a set of principles.
What does GLP ensure in laboratory studies?
Uniformity, consistency, reliability, reproducibility, and traceable data
These elements are critical for the integrity of laboratory research.
What types of studies do GLP-compliant laboratories perform?
Non-clinical and environmental studies
GLP is primarily applied to studies that do not involve clinical trials.
Fill in the blank: GLP provides a framework within which laboratory studies are _______.
[planned, performed, monitored, reported and archived]
These are essential components of the GLP framework.
True or False: GLP is only applicable to clinical research laboratories.
False
GLP applies to research labs conducting non-clinical and environmental studies.
What did the FDA become aware of in the early 1970s?
Poor laboratory practice all over the United States
What action did the FDA take regarding toxicology labs in the early 1970s?
Conducted an in-depth investigation on 40 toxicology labs
What did the FDA discover during their investigation of toxicology labs?
Fraudulent activities and poor lab practices
What is one example of poor lab practices found by the FDA?
Equipment not calibrated to standard form
What is another example of poor lab practices discovered by the FDA?
Incorrect/inaccurate accounts of the actual lab study
What is a third example of poor lab practices identified by the FDA?
Inadequate test systems (procedure & methods)
What is an example of a laboratory that faced investigation due to faulty practices of GLP?
Industrial Bio Test Lab
This lab conducted tests for major companies like Procter and Gamble.
What type of products were tested using mice at Industrial Bio Test Lab?
Cosmetics (lotion and deodorants)
The testing aimed to evaluate safety for human use.
What was discovered about the mice used in the tests at Industrial Bio Test Lab?
They developed cancer and died
This finding raised serious ethical and safety concerns.
What action did Industrial Bio Test Lab take regarding the dead mice?
Threw the dead mice and covered results
They falsely deemed the products safe for human use.
True or False: Industrial Bio Test Lab reported accurate results regarding the health of the test mice.
False
The lab hid the negative results to maintain product approval.
What prompted the FDA to promulgate the Good Laboratory Practice (GLP)?
Fraud practices and faulty result data submitted to the FDA by toxicology labs and pharmaceutical companies
This was a significant issue that led to the establishment of regulations to ensure data integrity.
When were the GLP regulations established by the FDA?
December 22, 1978
This date marks the official promulgation of the regulations, which are found in 21 CFR part 58.
When did the GLP regulations become effective in the USA?
June 1979
This was the date when the regulations began to be implemented.
Did GLP originate in the United States?
Yes, GLP originated in the United States
However, it had a significant worldwide impact.
What requirement did non-US companies face regarding GLP?
They had to comply with the United States GLP regulations to do business or register their pharmacies in the United States
This compliance influenced other countries to adopt similar regulations.
What organization was formed in 1961 to stimulate economic progress and world trade?
OECD (Organization for Economic Co-operation and Development)
This organization played a role in developing international standards.
What did the OECD develop in 1992?
GLP principles that are international standards
These principles help ensure consistency and reliability in laboratory practices worldwide.
In which countries was GLP first introduced in 1972?
New Zealand and Denmark
These countries were among the pioneers in adopting GLP before it spread globally.
What does GLP stand for?
Good Laboratory Practice
GLP is a quality system of management applicable to research laboratories and organizations.
What is the purpose of GLP?
To ensure uniformity, consistency, reliable, and reproducible data on the quality and integrity of chemicals
This includes pharmaceuticals and other chemicals.
What types of tests are conducted under GLP?
Non-clinical safety tests
These tests range from physio-chemical properties to acute and chronic toxicity tests.
What is the focus of non-clinical studies under GLP?
Assessment of the safety and efficacy of chemicals
This includes evaluation for humans, animals, and the environment.
What is included in physical-chemical testing under GLP?
Physical-chemical testing includes assessments of the chemical properties of substances
This may encompass solubility, stability, and other relevant characteristics.
What types of toxicity studies are conducted under GLP?
Toxicity studies include:
* Single dose toxicity
* Repeated dose toxicity (sub-acute and chronic)
These studies evaluate the harmful effects of substances on organisms.
What aspects are evaluated in reproductive toxicity studies?
Reproductive toxicity studies evaluate:
* Fertility
* Embryo-foetal toxicity and teratogenicity
* Peri-/post-natal toxicity
These studies assess the impact of substances on reproduction and development.
What are mutagenicity studies designed to assess?
Mutagenicity studies are designed to assess the potential of substances to cause genetic mutations
These studies help in understanding the risk of cancer or hereditary effects.
What do environmental toxicity studies focus on?
Environmental toxicity studies focus on:
* Aquatic organisms
* Terrestrial organisms
These studies evaluate the impact of chemicals on ecosystems.
What is the purpose of toxicokinetics studies?
The purpose of toxicokinetics studies is to provide systemic exposure data for toxicity studies
These studies help in understanding how substances are absorbed, distributed, metabolized, and excreted.
What do pharmacodynamic studies evaluate?
Pharmacodynamic studies evaluate the potential for adverse effects of substances
These are often referred to as safety pharmacology studies.
What is assessed in studies determining pesticide residues?
Studies determine pesticide residues in:
* Food
* Animal feedstuffs
These studies ensure food safety and compliance with regulations.
What do studies on effects on natural ecosystems examine?
Studies on effects on natural ecosystems examine the impact of substances on biodiversity and ecosystem health
These studies are crucial for environmental risk assessments.
What types of testing are included in analytical and clinical chemistry testing?
Analytical and clinical chemistry testing includes assessments of chemical composition and purity
These tests are essential for quality control and regulatory compliance.
What are the objectives of GLP?
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
List the GLP principles.
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
What role is played by the test facility organization and personnel?
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.
What are the study director responsibilities?
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.
What are the principal investigator responsibilities?
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.
Study personnel responsibilities
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.
what are the three types of inspection?
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. )
What are the requirements on apparatus, materials, and reagents?
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.
what is the 5s principle in the laboratory?
1.Sort
2.Set in order
3.Shine
4.Standardize
5.Sustain
what dooes the 5s system emphasize?
discipline, efficiency, and attention to detail
what are the types of test systems?
physical
chemical
biological
what is a requirement or protocol for biological test systems?
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)
What tests require the use of a standard?
assay
identification
purity
what happens if standards are not available?
recommendation is to take a lot of
your own material, and analyze, certify and use it as the standard.
what are SOPs?
Written procedures for a laboratories program.
a method of keeping records, reporting, storage, mixing, and retrieval of data.
