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Unit 19 - Practical Chemical Analysis Assignment 6 (Full)
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Assignment 5Unit 19 - Chemistry
In particular industrial/commercial contexts, there are six types of standard procedures which are used in
analysis and these are GLP (Good Laboratory Practice), SOP’s (Standard Operating Procedures), UKAS (United
Kingdom Accreditation Service), CLEAPPS (Consortium of Local Education Authorities for the Provision of
Science Services), calibration, and sampling. These terms will be explained in more depth as below;
Firstly, Good Laboratory Practice (GLP) is a set of principles which guides how laboratory studies are planned,
monitored, performed, recorded, reported, and achieved. It must be noted that GLP isn’t the same as
standards for laboratory safety, such as; appropriate gloves, clothing, and glasses for materials to be safely
handled in a lab. Good Laboratory Practice helps in ensuring the credibility and traceability of submitted data.
Through ensuring traceability and credibility GLP can address the issue of non-reproducibility in various
experiments of a biopharmaceutical manner. GLP is intended to minimise adverse drug effects, whilst
improving human health and environmental safety profiles. Through detailed and transparent documentation
of laboratory work whilst assigning responsibility at numerous steps in an experiment, GLP is able to aid in
improving data precision and accountability. Essentially, GLP is intended in assuring the integrity and quality of
non-clinical laboratory studies, conducted for the assessment of the safety or efficacy of chemicals and
pharmaceuticals to the environment, to animals, and to people, performed prior to the approval of new drugs
products. GLP is intended to support research or marketing permits for products which are regulated by
government agencies. It must be noted that GLP isn’t limited to chemicals and applies to food packaging,
medical devices, food additives, colour additives, along with other non-pharmaceutical ingredients or
products. Medicines and Healthcare products Regulatory Agency-UK defines GLP as; “GLP embodies a set of
principles which provide a framework within which laboratory studies are planned, performed, monitored,
recorded, reported, and achieved. GLP is important as it helps assure authorities that data which has been
submitted is true, that data is traceable, and promotes international acceptance of tests. The term GLP was
firstly used in 1972 in New Zealand. Good Laboratory Practices was instituted in the United States following
cases of fraud generated by toxicology labs in data which had been submitted to the Food & Drug
Administration (FDA) by pharmaceutical companies. Through these findings, the FDA promulgated GLP
Regulations, assuring the quality and integrity of safety, nonclinical laboratory studies. The reason for GLP was
because in the early 70’s the FDA became aware of cases of poor laboratory practices across the US. Due to
this they decided to do an in-depth investigation on 40 toxicology labs. When conducting this, they established
a lot of fraudulent activities and a lot of poor lab practices. Some examples of these poor lab practices are;
inadequate test systems, equipment not being calibrated to standard form, thus giving wrong measurements,
and the incorrect/inaccurate accounts of actual laboratory studies. One of the labs which went under
investigation was Industrial Bio Test, which made headline news. This was a big lab which ran tests for big
companies e.g. Gamble, Protector, etc. It was discovered that mice which they used to test cosmetics e.g.
deodorants, lotion, etc had developed cancer and died. Bio Test lab threw the dead mice and covered results
deeming the products as good for human consumption. Due to this, those which were involved in the
production, distribution, and sales for the lab eventually served jail time.
Secondly, Standard Operating Procedures (SOP’s) are known as documents which methods are recorded on so
employers and employees know what to do. These S.O.P documents need to be kept so employees within a
workplace are aware of the method that describes the specific way in which to carry out a certain technique of
a test. The reason these S.O.P’s must be kept is to ensure all following tests are always carried out to
perfection and to limit mistakes being made. This will be a step-by-step guide (instructions) of how the certain
thing are carried out with also all the health and safety measurements and risks associated with it, they also
describe how to perform routine activities. Employees should complete the tasks in the exact same manner
every time so that the industry can remain consistent. If employees didn’t follow an S.O.P essentially their
results could be deemed as invalid which then cause major complications or even hazards within the lab. SOP’s
must never be difficult to read or worded vaguely. They should be brief, easy to understand, and consist of
actions and steps which can be followed simply. A good SOP should clearly outline steps and inform
employee’s of any safety concerns. SOP’s should be the basis when it comes to training new employees. SOP’s
need to be updated every year to ensure they stay relevant to the current needs of the industry. SOP’s are
important as having these in place essentially streamline processes, so, employees are able to accomplish
more in less time, it also ensures that regardless what employee is working, that processes are being
conducted and completed in the correct manner. SOP’s can ensure that employees perform their job in a
manner which is consistent and safe. SOP’s would generally be stored in a file or a folder. The people who can
make changes, access or, record it are essentially everyone within a workplace as scientists carrying out
experiments will need access to these, along with head of departments, technicians, and others who play a
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, Assignment 5
Unit 19 - Chemistry
significance within the lab. SOP’s will be implemented through displaying written documents in areas where
they’ll be clearly visible to all employees. Having a standardised set of instructions in a lab is vital in ensuring
that every time a test is carried out it’s carried out the same way every time. This ensures that a piece of data
being collected if it needs to be repeated is able to be repeated and done in the same manner as it was when it
was done previously. Also have a standard operating procedure for each test that is carried out in a lab as it
makes it easier if a member of staff is unable to carry out a test or isn’t present on the day. Having a SOP
means that another lab technician can take over the station and follow the set of instruction of the SOP so that
the results are the same and that the lab work doesn’t get back up, this can be especially important in
hospitals where test can be vital in diagnosing illnesses and prescribing a course of treatment.
Thirdly, the United Kingdom Accreditation Service (UKAS) is a sole national accreditation body which is
recognised by the British government, to assess the competence of organisations, which provide certification,
inspection, testing, and calibration services. UKAS evaluates these conformity assessment bodies, before
accrediting them where they’re found to meet relevant internationally specified standards. This is an
accreditation that you’d want to receive. Having an accreditation like UKAS means that a lab is much more
likely to be trusted in relation to their analytical skills and the results which they obtain. Labs which have the
ability to meet a strict criteria along with standard of operation, and have the accreditation, in comparison to a
lab which doesn’t have the accreditation, in a court setting the judge may look at who analysed a piece of
evidence and how they analysed it, if a lab has the accreditation, it’ll essentially increase the strength of
evidence in a court scenario – this is rather important. This can also be applied to the scientific world as when
publishing data if a lab was to produce a formal document then a document with the UKAS symbol on it would
be more eye catching to somebody of a scientific background and they would be more likely to read the
document with a piece of accreditation on it compared to one without as it is simply seen as a more reliable
piece of information.
Next, Consortium of Local Education Authorities for the Provision of Science Services (CLEAPPS) is an advisory
service, which provides support in science and technology for a consortium of local authorities and schools, as
well as establishments for students with special needs. CLEAPSS was founded in 1965, by the Greater London
Council, in the attempt to promote high quality, effective practical work in science – which they have done for
over 50 years. Very soon after being founded, local educational authorities requested access to CLEAPSS
services on behalf of schools. CLEAPPS services cover equipment, health and safety, risk assessments, sources
and use of chemicals, and living organisms. CLEAPSS also provides advice regarding technicians and their jobs,
along with the design of laboratories and facilities and fittings for science rooms. CLEAPSS is important as it can
advice necessary personnel on all aspects of the role and legal requirements within education including the
safe storage and usage of chemicals. By following CLEAPSS guidelines, labs will be able to create their own risk
assessments and safety policy. CLEAPSS is important as if a lab fails to follow their advice, then they won’t
comply with COSHH regulations. The term COSHH means ‘Control of Substances Hazardous to Health’. COSHH
is the law which requires employers within a workplace to control substances which are hazardous to health.
Through COSHH health hazards can be established and how they can be prevented in a risk assessment. A
record of all chemical/ substance related incidents which cause harm to staff. CLEAPSS is linked with COSHH in
the sense that if CLEAPSS guidelines are followed, their Hazcards used, and their data safety sheets for the
chemicals used, and risk assessments written for the establishment or activity based on the information
CLEAPSS has provided, then COSHH regulations are being adhered too. Essentially, for COSHH regulations to be
complied with, CLEAPSS’ advice needs to be adapted to reflect the substances used, how they’re used, how
they’re stored and disposed of. It’s important to note that CLEAPSS will vary in different establishments, this is
because the risks will differ, along with the scheme of work being carried out, and the people who come into
contact with the substances.
After that, calibration is the known as the documented comparison of a measurement device to be calibrated
against a traceable reference device. Calibration is rather important, wherever measurements are important,
calibration is what allows users and companies to have confidence in the results which they monitor, record,
and subsequently control. Simply, calibration is known as the process of comparing a reading on one piece of
equipment or system with another piece of equipment which has been calibrated or referenced to a known set
of parameters. The equipment which is used as a reference should itself be traceable directly to the equipment
which is calibrated in accordance to ISO/IEC 17025. ISO/IEC 17025 is known as the International Standard for
the accreditation of Testing and Calibration Laboratories. It involves quality management system requirements
along with technical requirements. In the United Kingdom ISO.IEC 17025 accreditation is provided by UKAS.
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