Common asked Exam Q

Question 1

(a) List five quality tools which can typically be used as part of the Quality Management system for problem solving in the Biopharmaceutical/ Pharmaceutical industry. (5 Marks)

Answer 1

Check sheets, Flow charts, Cause and effect diagrams, histograms and scatter diagrams

Question 2

(b) Describe how any two quality tools are used in the Biopharmaceutical/ Pharmaceutical industry or laboratory use diagrams to illustrate your answer.

Answer 2

1)Flowcharts are pictorial representations of processes that break down complex operations into individual steps which facilitate the identification of potential error points within a system. They provide clarity on process sequences and highlight discrepancies between intended and actual paths
2) Scatter diagrams plot pairs of numerical data on two axes to explore a potential relationship between variables

Question 3

Explain the significance and role of each of the following bodies/organisations in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry. (5 Marks each- 25 Marks)
(a) ISO

Answer 3

ISO stands for International organisation for standardisation. This organisation determines the standards to increase the reliability and effectiveness of goods and services globally. Typical examples of ISO standards include ISO900:2015, ISO17025 and ISO 45001

Question 4

Explain the significance and role of each of the following bodies/organisations in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry. (5 Marks each- 25 Marks)
b) NSAI

Answer 4

NSAI is the National standards authority of Ireland and it is the official standards body that plays a significant role in QM. Its functions include standards development and certification. For example compliance with standards like ISO 9000, compliance with GMP standards, conducting audits and inspections

Question 5

Explain the significance and role of each of the following bodies/organisations in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry. (5 Marks each- 25 Marks)
c) INAB

Answer 5

INAB stands for Irish national accreditation board, the national body responsible for laboratory accreditation. It ensures that organisations are responsible for inspecting manufacturing facilities , processes and products . This guarantees that inspection processes are reliable and contribute to overall quality assurance. INAB also monitors compliance with GLP standards which ensures reliability and traceability.

Question 6

Explain the significance and role of each of the following bodies/organisations in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry. (5 Marks each- 25 Marks)
d) ICH

Answer 6

ICH stands for international council of harmonisation of technical requirements for pharmaceuticals that are for human use. There are 5 parameters that need to be validated in an analytical method as designed by the ICH, these include Specificity, precision ,Accuracy, linearity and range

Question 7

Explain the significance and role of each of the following bodies/organisations in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry. (5 Marks each- 25 Marks)
e) HPRA

Answer 7

HPRA stands for Health products regulatory Authority. It is a regulatory body in Ireland that is responsible for ensuring the safety, quality and efficacy of health products. The HPRA plays a vital role in QM and in biopharma industries through the following functions: Regulation ,GMP inspection and, Post marketing surveillance

Question 8

(a) Describe the four types of non-conformities that may be issued following an audit. [20 Marks]

Answer 8

1: Category 1/ Critical: When a company lacks a system, product or service deficiency, Corrective action must be completed before registration/certification can be granted

Category 2/Major: A system breakdown, meaning clearly documented provisions for a procedure exist and personnel are aware of them, for registration audits the company should provide a written undertaking that corrective action will be completed.

Category 3/other: An isolated non-conformity without a clear underlying cause. The audited activity demonstrates an acceptable level of implementation overall but there are minor discrepancies.

Category 4: An observation rather than a non-conformity. The auditor believes it warrants clarification to improve the overall status and effectiveness of the quality system

Question 9

(b) Distinguish between Internal and External audits. [5 Marks]

Answer 9

Internal audits are conducted by a company on their own systems, procedures and facilities. These are a legal requirement as part of the QA system to monitor GMP.
External audits are preformed by a company on their vendors or by a regulatory authority. They ensure control and confidence in sourcing materials and equipment

Question 10

Explain the significance and role of each of the following standards in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry/Medical Device Industries?
a) (a) ISO 9001:2015 [10 Marks]

Answer 10

ISO 9001:2015 is a quality management system that is incorporated into companies pharmaceutical quality systems and requires certification by suppliers. It helps businesses to be more efficient, to improve customer satisfaction and to monitor the system. These broad principals of control allow for the standard to be interpreted and implemented by many types of organizations.
There are 3 important clauses in ISO 9001:2015, The process approach, PDCA and risk-based thinking. The leadership requirement in ISO 9001:2015 are ensuring the Quality policy and quality objectives are established for the QMS, ensuring the integration of QMA requirements into the organisations business processes. Ensuring the QMS achieves its Intended results

Question 11

Explain the significance and role of each of the following standards in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry/Medical Device Industries?
b) ISO 14001:2015 (5 Marks)

Answer 11

ISO 14001:2015 is a standard about environmental management. It focuses on how an organisation can lower its negative environmental impact, It is done by using risk assessments and the plan do check act cycle. Organisations list and prioritise environmental aspects and impacts in 5 categories: Wastewater, Air emissions, hazardous solid waste, raw materials, water and energy.

Question 11

Explain the significance and role of each of the following standards in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry/Medical Device Industries?
c) ISO 45001:2018 (5Marks)

Answer 11

ISO 45001:2018 was developed to combat the significant burden of occupational injuries and diseases on employers. This certification helps organisations to manage occupational health and safety risks and improve OH&S performances. To ensure a robust system in place complies with OH&S regulations. Benefit from, fewer accidents

Question 12

Explain the significance and role of each of the following standards in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry/Medical Device Industries?
d) ISO 17025:2018 (5 Marks)

Answer 12

ISO 17025:2018 contains 5 main sections which are general requirements, structural requirements, resource requirements, process requirements and management requirements. It uses risk assessment and a process approach to work, SOPs, standards, references, software and manuals must be controlled

Question 13

Explain each of the following acronyms of these organisations and their roles in relation to
Quality Management in the Biopharmaceutical/ Pharmaceutical Industry/Medical device
industries?
(a) EMA

Answer 13

EMA stands for European medicine agency and it plays a central role in ensuring the quality, safety and efficiency of medicines across the EU. Its role in QM includes regulatory oversight, marketing authorisation, harmonisation of standards and inspections and audits

Question 14

Explain each of the following acronyms of these organisations and their roles in relation to
Quality Management in the Biopharmaceutical/ Pharmaceutical Industry/Medical device
industries?
(d) FDA

Answer 14

FDA stands for the Food and drug administration and is a regulatory authority in the united states that is responsible for ensuring the safety, efficacy and security of drugs, medical devices and food. The FDA enforces strict GMP regulations to ensure that drugs are produced consistently to meet quality standards. They do this by conducting routine inspections of facilities.

Question 15

Explain each of the following acronyms of these organisations and their roles in relation to
Quality Management in the Biopharmaceutical/ Pharmaceutical Industry/Medical device
industries?
e) HSA

Answer 15

HSA stands for health and safety authority and is the state sponsored body in Ireland that is responsible for ensuring safety, health and welfare at work, monitoring compliance with health and safety laws in the work place, undertaking and sponsoring research on health and safety at work.

Question 16

(a) Identify the legislation used to regulate workplace safety in Ireland?

Answer 16

The primary piece of legislation is the safety, health and welfare at work act 2005. This act outlines the duties of the employers, employees and others responsible for safety in the workplace.

Question 17

(b) What does this legislation ( safety, health and welfare at work act 2005) require the employer to do to ensure a healthy and safe work environment? [5 Marks]

Answer 17

It requires the employer to create and maintain a safe and healthy working environment, managing the workplace to ensure the safety and health of people at work, providing and maintaining a safe workplace with safe access, providing information, instruction, training and providing PPE

Question 18

(c) Risk assessment is typically a three-step process. Identify each of the steps and explain each step-in detail using examples. [15 Marks]

Answer 18

A risk assessment is a systematic process that is used to Identify, evaluate and control hazards in the workplace.
The 3 steps include:

Identification of the hazards: This step includes identifying all potential hazards that could cause harm in the workplace. This is done via inspections, reviewing accident reports or consulting employees. An example of a hazard in pharmaceuticals is exposure to hazardous chemicals.

The next step is Risk evaluation: When hazards are identified, the risks are evaluated for each hazard presented. This assesses how likely it is that harm will occur and its severity. This is done by classifying the hazard into categories which prioritises the risks that require immediate action using a risk matrix. An example of this is if workers are handling these hazardous chemicals the likelihood of exposure would be high.

The final step is risk control. This step involves deciding what actions should be taken to eliminate or control the identified risks. This implements control measures that either reduce the likelihood of risks occurring or minimises their consequences.

This is done by controlling measures that follow a hierarchy of controls starting with the most effective to the least effective. An example of this is substituting the hazardous chemical for a less hazardous one or ensuring employees wear the correct PPE

Question 19

Explain the significance and role of each of the following bodies/organisations in relation to Quality Management in the Biopharmaceutical/ Pharmaceutical Industry. (d) REACH [5 Marks]

Answer 19

REACH is the registration, Evaluation and authorisation of chemicals it is a European program that regulates how chemicals are safely managed within the EU. SDS pages provide useful information on chemicals and describing the hazards they present. This ensures safety for the personnel in the lab

Question 20

) Identify 3 different Quality management systems that can be integrated in
Biopharmaceutical/ Pharmaceutical Facilities
Principle:

Answer 20

Ensures that the quality system must ensure that products are fit for their intended use. Compliance with the marketing authorisation is mandatory. The quality system must incorporate GMP and quality risk management

Question 21

Identify 3 different Quality management systems that can be integrated in
Biopharmaceutical/ Pharmaceutical Facilities
Pharmaceutical Quality system:

Answer 21

product realisation should be achieved by designing, planning and continuously improving processes to deliver the desired quality. Product and process knowledge must be managed throughout all stages of product lifecycle

Question 22

Identify 3 different Quality management systems that can be integrated in
Biopharmaceutical/ Pharmaceutical Facilities
Good manufacturing practice for medicinal products:

Answer 22

Compliance with GMP principles is mandatory for manufacturing processes must ensure consistent production quality.

Question 23

(a) Identify the Nine Environmental principles of sustainability embedded in EU law
over the last 30 plus years? [18 Marks]

Answer 23

1)Precautionary Principle: Actions are risk based and a lack of scientific certainty is not a reason for postponing measures to prevent environmental degradation. Used where there are reasonable grounds

2) Preventative action: Taking measure to avoid harm (Such as pollution). This is done to avoid harm, avoid costs, avoid complication, Must have scientific evidence that harm that would be done if action not taken.

3) Rectifying environmental damage at source: Environmental damage is a priority addressed by targeting its original cause and taking preventative action at the origin of the problem.

4) Polluter Pays principle: Where possible, the cost should be borne by those causing the damage

5) Sustainable development: Covered in national planning framework and now by the UNEP SDG

6) Integration: A recognition that everything is connected in an independent web of being in the world which is considered in decision making, social and environmental aspects of an issue

7) Public access to environmental information: All information on environmental matters held by public bodies is open to scrutiny by the public to increase transparency

8) Public participation: Recognises that effective environmental decisions require public participation by all citizens.

9) Access to justice with environmental matters: Means access to judicial proceedings for citizens to highlight the importance of review procedures and involvement

Question 24

Explain two of the Nine Environmental principles of sustainability in the context of
the regulated Biopharmaceutical, Pharmaceutical and Medical Device industries?

Answer 24

The Principle of Prevention
This principle involves taking steps to avoid harm, such as pollution, helps to avoid harm, costs, and complications, but must be supported by scientific evidence.

The Principle That Environmental Damage Should Be Rectified at Source
Addressing environmental damage by targeting its original cause and taking preventative action is a priority. The responsibility for managing environmental damage is on the polluter

Question 25

Describe the typical contents of a quality manual based on the EU GMP
Pharmaceutical Quality System? [10 Marks]

Answer 25

The quality manual should contain the quality policy, The cope of the Pharma Quality system, I.D of the PQS processes and their sequences, Process maps and flow charts which depict PQS processes in a visual manner, Management responsibilities within the PQS

Question 26

(b) Identify two sections to be included in the quality manual & explain each
section? [2.5 Marks each]

Answer 26

The Pharmaceutical quality system processes, this depicts what are the key activities that occur at the organization i.e. purchasing, manufacturing and testing
Management responsibilities i.e. who are the senior management and what is their involvement in QMS

Question 27

Explain the terms Qualification and Validation.

Answer 27

Validation is establishing documented evidence that provides a high degree of assurance that a process will consistently produce a product that meets its specifications and quality

Qualification is the demonstration that equipment, utilities, and systems are suitable for their intended use. It is a mandatory requirement in the pharmaceutical industry and is considered part of validation

Question 27

Explain the following parameters which can be found in the validation
protocol of an analytical method: Specificity

Answer 27

Specificity is “the ability to measure the analyte in the presence of components that might be expected to be present”. These components include impurities or degradants. Specificity can be tested by making a mixture containing the analyte and potential sample components and comparing this result to a result for the analyte on its own.

Question 28

Explain the following parameters which can be found in the validation
protocol of an analytical method: Precision

Answer 28

Precision is “the closeness of agreement between a series of measurements gathered from multiple sampling of the same sample under the prescribed conditions”. It may be considered at three levels: repeatability, intermediate precision and reproducibility

Question 29

Explain the following parameters which can be found in the validation
protocol of an analytical method: Accuracy

Answer 29

Accuracy “the closeness of agreement between the conventional true value or a standard and the value found”.

Question 30

Explain the following parameters which can be found in the validation
protocol of an analytical method: LOD

Answer 30

The lowest amount of analyte in a sample which can be detected but not necessarily quantified.

Question 31

Explain the following parameters which can be found in the validation
protocol of an analytical method: Range

Answer 31

“the interval from the upper to the lower concentration of analyte in the sample”. It is normally expressed in the same units as the test results