Unit 4 Learning Aim A Year 12 Applied Science L3
Assignment 4A
Health and Safety In work in science organisations.
Learning Aim A Criteria:
P1 Explains how the health and safety protocols of a scientific institution
align with regulatory requirements.
P2 Explain the possible risks that are important to the various environments in
which scientists work.
M1 Compare the health and safety precautions applied in connection with the
legalisation of various scientific work environments that may present risks.
D1 Examine the steps taken for various work environments to guarantee high
health and safety standards that comply with legal requirements. Commented [ee1]: It is clear that you have worked at
great length to address every section. In addition, you have
highlighted some of the relevant Health and Safety
Regulations in relation to your work = Distinction
Introduction
In this assignment I am a health and safety inspector working for the government. In
this role, I have been assigned to visit a pharmaceutical company and to report on
the health and safety practices within this organisation.
I have chosen to inspect the pharmaceutical company known as Astrazeneca and I
will focus my inspection on two departments. Firstly, the Biopharmaceuticals
Department where the COVID-19 vaccine is mass produced. Secondly, I will inspect
the Research and Department Oncology department, where research and
development is being carried out to study drugs to fight cancer. In particular, I will be
focusing on the drugs being developed to fight lung cancer. In my role as an
inspector, I will explain the risks in the Biopharmaceuticals Department and
Oncology Research and Development Department and the precautions and health
and safety measures Astrazeneca takes to comply with the current legislation.
Following this, I will compare the legislation that applies to the two different working
environments; and finally, I will consider the measures Astrazeneca takes to ensure
high standards of health and safety that comply with legislation. I will consider the
benefits and constraints of Astrazeneca’s health and safety systems in these two
departments, and will make recommendations for improvements.
General Health and Safety Every Company Should Observe
The Health and Safety at Work etc Act 1974 was created to ensure the safety and
protection of employees, employers and visitors to their premises. This law is
mandatory but there are also voluntary accreditations that a company can acquire by
meeting criteria to demonstrate very high levels of health and safety.
1
,Unit 4 Learning Aim A Year 12 Applied Science L3
All companies would benefit from having ‘Laboratory Accreditation’ to ISO/IEC
17025. This accreditation is not mandatory but does confirm that an organisation’s
labs meet a range of criteria which includes employing qualified, trained and
experienced staff who will be familiar and used to adhering to legislative health and
safety rules. This accreditation confirms that a company has suitable and safe
testing facilities; the right equipment; appropriate testing procedures and proper
sampling practices. Companies that undertake these tests on a voluntary basis
boost their reputation and public confidence in their health and safety practices. I
could not find evidence that Astrazeneca has this accreditation status for its UK
Research and Development site based in Cambridge.
Pharmaceutical companies should have health and safety regulation signs on doors.
These signs should show rules that will ensure lab safety in general and then also for
handling hazardous chemicals. Providing such a list of rules is evidence that a
company is adhering to: the Occupational Safety and Health Administration (OSHA)
Regulations. Astrazeneca does not have this, however I found evidence that they
deliver a risk awareness module to all employees and they have a senior executive
team that are responsible for every worker to be aware of safety, health and
environment standards.
Department One - Biopharmaceuticals
There are mainly 4 categories of biopharmaceutical products, these are vaccines,
therapeutic proteins, blood and blood components, and tissues. These are important
because they help improve life quality by identifying problems and figuring out ways
to solve them. Many people with illnesses, infections or diseases rely on
biopharmacy for treatments, remedies and solutions.
In my opinion the processes that take place in the Biopharmaceuticals Department
pose a number of potential risks and hazards to its staff. Manufacturing
biopharmaceuticals, for example different vaccines, involves cultivation of living
cells, which operate as the target therapeutic proteins' factories. Biopharmaceutical
manufacturing also consists of infectious pathogens, like bacteria viruses and fungi.
These create potential high risks and hazards to health. Astrazeneca’s
Biopharmaceutical Department produces the COVID-19 vaccine, I will now describe
the method used to mass produce the vaccine and the risks imposed by working with
the materials used in it.
2
, Unit 4 Learning Aim A Year 12 Applied Science L3
Method to mass producing the Covid-19 vaccine
Antigen production requires either cultivating the virus in cell cultures (inactivated
or weakened) , this means the employers are being exposed to the virus , which
creates the risk of them catching the virus.
The antigen is then blended with a variety of stabilisers and other substances to
create an effective and stable vaccination.
The vaccine is placed in vials, ampoules, or syringes, which are subsequently
packed into larger containers for distribution.
Quality control methods are in place throughout the process to guarantee that the
vaccination is safe, effective, and fulfils quality requirements. This involves assessing
the vaccine's efficacy, purity, and sterility.
Risks that are associated with mass producing the covid-19 vaccine.
There are risks if there isn’t a consistent supply of vaccines for prospective patients.
Any supply chain interruption, such as raw material or equipment shortages, may
have an influence on vaccine manufacturing and delivery. This means that the
treatment is unreliable and may gain a poor reputation or reduced sales because
doctors and hospitals cannot rely on the service.
There are also risks associated with the quality of the final product. Maintaining a
consistent high quality across millions of doses is difficult and necessitates stringent
quality control techniques. Failure to uphold quality standards may result in
ineffective or dangerous vaccinations. In fact, Astrazeneca’s Covid 19 vaccine was
criticised because it had a negative impact on some members of the public who
received the vaccine. In 2022, The Guardian Newspaper reported that when the
vaccine was first released in 2020, there were concerns over rare blood clot
implications. Astrazeneca needs to manage these risks by ensuring that the final
product is fit for purpose, however there is always a small risk that a minority of
people might receive a negative effect from the final product. The two images below
show risks in biopharmaceuticals during development, mass production, distribution
and finally selling the products.
3
Assignment 4A
Health and Safety In work in science organisations.
Learning Aim A Criteria:
P1 Explains how the health and safety protocols of a scientific institution
align with regulatory requirements.
P2 Explain the possible risks that are important to the various environments in
which scientists work.
M1 Compare the health and safety precautions applied in connection with the
legalisation of various scientific work environments that may present risks.
D1 Examine the steps taken for various work environments to guarantee high
health and safety standards that comply with legal requirements. Commented [ee1]: It is clear that you have worked at
great length to address every section. In addition, you have
highlighted some of the relevant Health and Safety
Regulations in relation to your work = Distinction
Introduction
In this assignment I am a health and safety inspector working for the government. In
this role, I have been assigned to visit a pharmaceutical company and to report on
the health and safety practices within this organisation.
I have chosen to inspect the pharmaceutical company known as Astrazeneca and I
will focus my inspection on two departments. Firstly, the Biopharmaceuticals
Department where the COVID-19 vaccine is mass produced. Secondly, I will inspect
the Research and Department Oncology department, where research and
development is being carried out to study drugs to fight cancer. In particular, I will be
focusing on the drugs being developed to fight lung cancer. In my role as an
inspector, I will explain the risks in the Biopharmaceuticals Department and
Oncology Research and Development Department and the precautions and health
and safety measures Astrazeneca takes to comply with the current legislation.
Following this, I will compare the legislation that applies to the two different working
environments; and finally, I will consider the measures Astrazeneca takes to ensure
high standards of health and safety that comply with legislation. I will consider the
benefits and constraints of Astrazeneca’s health and safety systems in these two
departments, and will make recommendations for improvements.
General Health and Safety Every Company Should Observe
The Health and Safety at Work etc Act 1974 was created to ensure the safety and
protection of employees, employers and visitors to their premises. This law is
mandatory but there are also voluntary accreditations that a company can acquire by
meeting criteria to demonstrate very high levels of health and safety.
1
,Unit 4 Learning Aim A Year 12 Applied Science L3
All companies would benefit from having ‘Laboratory Accreditation’ to ISO/IEC
17025. This accreditation is not mandatory but does confirm that an organisation’s
labs meet a range of criteria which includes employing qualified, trained and
experienced staff who will be familiar and used to adhering to legislative health and
safety rules. This accreditation confirms that a company has suitable and safe
testing facilities; the right equipment; appropriate testing procedures and proper
sampling practices. Companies that undertake these tests on a voluntary basis
boost their reputation and public confidence in their health and safety practices. I
could not find evidence that Astrazeneca has this accreditation status for its UK
Research and Development site based in Cambridge.
Pharmaceutical companies should have health and safety regulation signs on doors.
These signs should show rules that will ensure lab safety in general and then also for
handling hazardous chemicals. Providing such a list of rules is evidence that a
company is adhering to: the Occupational Safety and Health Administration (OSHA)
Regulations. Astrazeneca does not have this, however I found evidence that they
deliver a risk awareness module to all employees and they have a senior executive
team that are responsible for every worker to be aware of safety, health and
environment standards.
Department One - Biopharmaceuticals
There are mainly 4 categories of biopharmaceutical products, these are vaccines,
therapeutic proteins, blood and blood components, and tissues. These are important
because they help improve life quality by identifying problems and figuring out ways
to solve them. Many people with illnesses, infections or diseases rely on
biopharmacy for treatments, remedies and solutions.
In my opinion the processes that take place in the Biopharmaceuticals Department
pose a number of potential risks and hazards to its staff. Manufacturing
biopharmaceuticals, for example different vaccines, involves cultivation of living
cells, which operate as the target therapeutic proteins' factories. Biopharmaceutical
manufacturing also consists of infectious pathogens, like bacteria viruses and fungi.
These create potential high risks and hazards to health. Astrazeneca’s
Biopharmaceutical Department produces the COVID-19 vaccine, I will now describe
the method used to mass produce the vaccine and the risks imposed by working with
the materials used in it.
2
, Unit 4 Learning Aim A Year 12 Applied Science L3
Method to mass producing the Covid-19 vaccine
Antigen production requires either cultivating the virus in cell cultures (inactivated
or weakened) , this means the employers are being exposed to the virus , which
creates the risk of them catching the virus.
The antigen is then blended with a variety of stabilisers and other substances to
create an effective and stable vaccination.
The vaccine is placed in vials, ampoules, or syringes, which are subsequently
packed into larger containers for distribution.
Quality control methods are in place throughout the process to guarantee that the
vaccination is safe, effective, and fulfils quality requirements. This involves assessing
the vaccine's efficacy, purity, and sterility.
Risks that are associated with mass producing the covid-19 vaccine.
There are risks if there isn’t a consistent supply of vaccines for prospective patients.
Any supply chain interruption, such as raw material or equipment shortages, may
have an influence on vaccine manufacturing and delivery. This means that the
treatment is unreliable and may gain a poor reputation or reduced sales because
doctors and hospitals cannot rely on the service.
There are also risks associated with the quality of the final product. Maintaining a
consistent high quality across millions of doses is difficult and necessitates stringent
quality control techniques. Failure to uphold quality standards may result in
ineffective or dangerous vaccinations. In fact, Astrazeneca’s Covid 19 vaccine was
criticised because it had a negative impact on some members of the public who
received the vaccine. In 2022, The Guardian Newspaper reported that when the
vaccine was first released in 2020, there were concerns over rare blood clot
implications. Astrazeneca needs to manage these risks by ensuring that the final
product is fit for purpose, however there is always a small risk that a minority of
people might receive a negative effect from the final product. The two images below
show risks in biopharmaceuticals during development, mass production, distribution
and finally selling the products.
3
