Test 1 2022 Questions Flashcards
Many new concepts and abbreviations of quality assurance have been introduced by
guidelines of international organisations.
Write the names of the three abbreviations QM, QMS, LIMS and explain
how they can be used to underpin quality in the laboratory
QM: Quality manual
QMS: Quality management system
LIMS: Laboratory information management system
QM: This document is extensive, as it contains all relevant information to run
the laboratory and to secure quality of the results. It is the intention that
everyone, who is skilled in the art, should be able to operate the apparatuses
and obtain quality results with this document at hand.
QMS: The ISO 9001 is the overall quality management system that has been
adopted worldwide and it is the legal foundation for the validity of results that
are produced in accredited laboratories. The ISO 17025 standard is a sub-
standard of ISO 9001 that speaks specifically to laboratories of analytical
chemistry and ISO 5725 is the standard the explains the corresponding data
management. In the new system, the Eurachem/CITAC guides and the BIPM
GUM are taking over with respect to method validations and QA/QC but the
practices and procedures of reporting according to ISO 17025 remains the
same.
LIMS: The LIMS refers to the recording and management of data by
computers and the most recent versions of the LIMS are cloud-based systems.
Therefore, many statistical operations and bar coding of samples as well as
customer relations are handled by the LIMS.
Many international organisations have contributed to develop the new system of
quality assurance that has been adopted by numerous countries. The efforts of
introducing the system of quality assurance were based on experience with flawed
research, issues with certain environmental investigations and issues with lack of
performance of professional accredited laboratories.
In the survey of the Royal Society of Chemistry, that was conducted by Alan
Handley in 2006, it became clear that something had to be done to improve the then
unacceptable situation in analytical laboratories. Describe the main outcome of the
survey and what was proposed to alleviate the issues with quality of analytical
chemistry
It was established that the industry recommended education in QA should be
delivered by the universities
The general level of knowledge of QA/QC was low among PG students and
virtually non-existent among undergraduates
4. More education in QA/QC is needed both in the industry and academia
In the revised Helsinki Declaration of 2013, the concept of placebo and the use of
placebo were highlighted. What is the issue with the use of placebo in chemical trials
that are aimed at developing new pharmaceutical products?
The issue with the use of placebo in chemical trials aimed at developing new pharmaceutical products lies in the ethical considerations and potential confusion among participants. Placebo usage can lead to uncertainty and misunderstanding among trial participants if they are aware of what they are receiving beforehand. To address this concern, human trials must be conducted as double-blind experiments. In double-blind trials, neither the volunteers nor the medical staff know the contents of the tablets being administered.
The revised Helsinki Declaration of 2013 emphasizes the importance of testing new interventions against the best proven ones. However, there are certain circumstances where the use of placebo is deemed acceptable, such as when no proven intervention exists or when methodological reasons necessitate its use
Three international initiatives take care of the protection of animal welfare and
the use of animals in the development of pharmaceutical products. What are the
names of these three initiatives/organisations?
Basel Declaration
2. International Convention for the Protection of Animals
3. World Organisation for Animal Health (WOAH)
Explain how the outcome of human trials and animal trials depend on the quality
of analytical measurements
The outcome of both human and animal trials relies heavily on the quality of analytical measurements. Analytical chemistry methods monitor medication contents and impurity levels throughout product development. Failure to identify hazards can lead to unforeseen adverse effects and costly repercussions. Accurate measurements are crucial for mitigating risks and ensuring project progress. Therefore, laboratory staff and analytical laboratories shoulder significant responsibility to maintain quality standards.
List ten sources of uncertainty in analytical chemistry
Sampling
Storage conditions
Instrument effects
Reagent purity
Assumed stoichiometry
Measurement conditions
Sample effects and interferences
Computational effects
Blank correction
Operator effects
Random effects
