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Quality Assurance Flashcards

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1
Q

How can the quality and suitability of a product for use be determined?

A

By use of a specification outlining tests and relevant margins for error. There can be both a BP specification and an in house specification; with both having different information in them (though there may be some overlap).

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2
Q

What are the limitations of end product testing?

A

You cannot guarantee fault free products by end-product testing alone. The system of inspecting, rework, or scrap sub-standard material is outmoded.

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3
Q

What alternative system for ensuring the quality of products is there other than end product testing?

A

Quality management and/or quality assurance. Controlling the variables that determine the output so that you do not produce defective material.

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4
Q

Define quality management.

A

Accountability for the successful implementation of the quality system.

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5
Q

Define a quality system.

A

A formalised business practice that defines management responsibilities for organisational structure, processes, procedures, and resources needed to fulfil product/service requirements, customer satisfaction, and continual improvement.

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6
Q

What is the main variable in a production/dispensing process we must control?

A

People.

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7
Q

How do we strive for quality?

A

We strive for quality by perfecting the process rather than the conclusion. This enables us to build quality into products and services - which is more preferable to the more costly, less effective methods of inspecting rejects out.

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8
Q

Why does the public rely on the knowledge that there are effective quality assurance processes in place for pharmaceuticals?

A

Because they take medicines on trust from the doctor or pharmacist and by extension the manufacturer. They cannot test them before they take them in a similar way that they can with a car of clothes.

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9
Q

How is the quality of pharmaceutical products assessed? What falls under this umbrella?

A

Quality of a pharmaceutical product is measured by its fitness for the intended use. Safety and efficacy are part of quality and are not separable.

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10
Q

What factors can be used to assess whether a pharmaceutical product is fit for use/purpose?

A
  • Correct product.
  • Correct strength,
  • Free from contamination.
  • No deterioration.
  • Correct container.
  • Correct label.
  • Sealed container.
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11
Q

What is the orange guide?

A

A book of rules and guidance for pharmaceutical manufacturers and distributors.

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12
Q

How many volumes are there of the EU Legislation - Eudralex?

A

10.

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13
Q

What does volume 2 of the EU Legislation - Eudralex include?

A

Notice to applicants and regulatory guidelines for medicinal products for human use.

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14
Q

What does volume 10 of the EU Legislation - Eudralex include?

A

Guidelines for clinical trials.

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15
Q

What does volume 4 of the EU Legislation- Eudralex include?

A

Guidelines for good manufacturing practice for medicinal products for human and veterinary use.

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16
Q

What does the acronym GMP stand for?

A

Good manufacturing practice.

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17
Q

What is the EU Legislation - Eudralex?

A

The collection of rules and regulations governing medicinal products in the European Union.

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18
Q

What is included in volume 4 of Eudralex?

A
  • Introduction
  • Part I Basic requirements for Medicinal Products
  • Part II Basic requirements for API
  • Part III GMP related Documents
  • Annexes
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19
Q

Outline the chapters detailing GMP in volume 4 of Eudralex.

A 
- One: Pharmaceutical Quality System
• Two: Personnel
• Three: Premises and Equipment
• Four: Documentation
• Five: Production
• Six: Quality Control
• Seven: Outsourced Activities
• Eight: Complaints, Quality Defects and Product Recall
• Nine: Self-Inspection
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20
Q

How many annexes are there in volume 4 of Eudralex, outlining GMP? What is included in them?

A
  1. They provide information on more specific areas, mainly of specific areas of manufacture (e.g. sterile and non-sterile, herbal products). This has increasingly included; risk, computerised systems, validation, certification by QPs, parametric release, APIs.
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21
Q

What falls under the umbrella of quality assurance/quality management?

A

Everything that makes a product fit for use. Including; production, R&D, quality control, training, and documentation.

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22
Q

Define quality management/quality assurance.

A

Quality Management is a wide-ranging concept,
which covers all matters, which individually or
collectively influence the quality of a product. It is
the sum total of the organised arrangements
made with the objective of ensuring that
medicinal products are of the quality required for
their intended use. Quality Management
therefore incorporates Good Manufacturing
Practice.

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23
Q

Define good manufacturing practice.

A

Ensures that the products are reproducibly manufactured fit for practice. Is that part of Quality Assurance aimed at
ensuring that products are consistently
produced and controlled to a quality
standards appropriate to their intended use
by the Marketing Authorisation, Clinical Trial Authorisation or product specification. It is
thus concerned with both production and
quality control.

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24
Q

Define quality control.

A

Testing and all associated with testing,
and final product release. Is that part of Good Manufacturing Practice which
is concerned with sampling, specification and
testing, and with the organisation, documentation
and release procedures which ensure that the
necessary and relevant tests are actually carried
out and that materials are not released for use,
nor products released for sale or supply, until their
quality has been judged to be satisfactory.

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25
What is product quality review?
regular review, usually annually, of a finished product or a range of finished products. This should include; starting materials, in-process checks, out of specification deviations, complaints, change, and ongoing stability studies.
26
What is quality risk management?
A systematic process to assess, control, and review risks.
27
What is a full product license?
A Medicines and Healthcare products Regulatory Agency (MHRA) license for a specific product. Usually given to the larger pharmaceutical companies to produce specific products.
28
What is a pharmaceutical special?
A medicinal product manufactured in an MHRA licensed unit to the specification of a prescriber.
29
What is special about an unlicensed medication?
Gives the prescriber a level of clinical freedom. Often used for patients with special needs such as paediatrics or geriatrics. The pharmacist or prescriber is responsible for the safety of the product legally.
30
Give some examples of situations in which medicines may be unlicensed but still used for patients with special needs.
imported into the UK that are licensed abroad but not licensed in the UK • imported into the UK that are not licensed abroad or in the UK • licensed in the UK, but not used for their licensed indication (off label) • prepared as “Specials” by licensed manufacturers but do not hold marketing authorisations • dispensed medicines (Section 10) – under the supervision of a pharmacist
31
Explain what the law says about the responsibility of a qualified person (QP).
Each batch of a finished product must be certified by a QP within the EC/EEA before being released for sale or supply in the EC/EEA or for export.
32
What must a person have to apply to be classed as a qualified person (QP)?
Membership to the RPS, Institute of biology, or the royal society of chemists. Relevant body of knowledge. Suitable experience. Must have passed a Viva interview.
33
What is are the objectives of documentation in quality assurance?
``` State in advance what has to be done • Do it in accordance with the instructions • Make a record of what has been done ```
34
What are the reasons for completing documentation in quality assurance?
``` Approved Instructions – Reproducible products – Training • Defined standards • Confirmation that steps have been carried out • Records • Investigation of Complaints • Help necessary corrective actions ```
35
What types of documentation are there in quality assurance?
``` • Specifications • Manufacturing and Packaging Instructions • Standard Operating Procedures (SOP’s) • Records ```
36
What are product specifications?
``` * State standards which materials and products should meet. • Describe the tests for the standards • Include: – Starting materials – Packaging materials – Intermediate and bulk products – Finished products ```
37
What do manufacturing and packing instructions include?
• State all the starting materials • Detail all processing and manufacturing details • Describe packaging processes
38
What are standard operating procedures (SOPs)?
``` • Directions or information on performing operations • Examples: – Cleaning – Changing – Equipment operation – Environmental monitoring ```
39
What are records in quality assurance and what should they include?
``` • Product batch history • Include: – Issue and receipt of starting materials – Production and packaging records – Distribution records – Complaint records – Exception and out-of-spec records – Training Records – Plant and Equipment records ```
40
What does chapter 4 of the Orange Guide explain about documents?
Chapter 4 is a general list of all documents required and what should be in then (Use as a checklist).
41
Explain the documentation control needed in the quality assurance process.
``` All documents are available to those that need them • Kept up to date staff aware of updates • Revisions formal and authorised • Copy Numbers • Record who is issued with copies – Use a table on the reverse of the master sheet • Removal of all superseded copies ```
42
What should a final specification for a product include?
* Title * Description * Identification * Related Substances * Assay (Including relevant limits) * Microbiological specification * Volume Checks
43
What two types of control charts are used in quality assurance?
Shewhart plots and cusum (cumulative sum) plots.
44
Define validation in quality assurance.
Is the action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results.
45
Define qualification in quality assurance.
* Is the action of proving that any equipment works correctly and actually leads to the expected results. * The word “Validation” is sometimes widened to incorporate the concept of Qualification.
46
What needs validation in a hospital aseptic suite?
``` •Isolators •Clean Rooms •Computers •Automated Filling Equipment •Production Process •Packaging • Syringes, Hubs, Infusion Devices, Bags •Cleaning Processes - Does it clean effectively, deposits of product and/or deposits of cleaning agents. •Sterility Testing •Quality Control Instruments - Active air samplers •Change - Facilities, Equipment and Processes. ```
47
What is a validation master plan?
``` •Important document or booklet •Defines the company policy on validation •Describes the general process to validation •Lists the equipment and processes to be validated •Defines the priority order ```
48
Define design qualification (DQ).
Ensuring the design is suitable for use.
49
Define installation qualification (IQ).
Ensuring equipment is installed or modified in compliance with design. This may be a one-off when the equipment arrives on site.
50
Define operation qualification (OQ).
Ensuring the equipment performs through-out the operational range.
51
Define performance qualification (PQ).
Ensuring the equipment continues to perform as designed during operational life.
52
What is a validation workbook?
``` •Important document or booklet Second to the VMP •One booklet for each instrument or process to be validated • Four main sections DQ, IQ, OQ, and PV Each of the four main sections divided into: • Method statement (how you are going to do it – including specification or expected results) • Sign off of method statement • Results • Out of Specification results • Sign off and move to the next section ```
53
Incidents can be subdivided into what categories?
• Out of Specifications - Results not meeting pre-defined specification - Batch with assay failure • Deviations - Departure from approved instruction or procedure • Complaint - Result of product not complying to customers expectation
54
Explain CAPA - corrective actions/preventative actions.
This is a regulatory concept that focuses on the systematic investigation, understanding, and correction of discrepancies while attempting to prevent their reoccurrence
55
Why is CAPA (corrective actions/preventative actions) used?
•Regulatory Requirements - FDA, MHRA and ISO require an active CAPA program as an essential element of a quality system. •Customer Satisfaction - The ability to correct existing problems or implement controls to prevent potential problems is essential for continued customer satisfaction •Good Business Practice - Quality problems can have a significant financial impact on a company
56
In CAPA, what are remedial actions?
Actions that are required immediately to limit the impact of the error or deviation.
57
In CAPA, what are corrective actions?
* Action to eliminate the cause of a detected deviation * Prevents reoccurrence within the same area or process * Can only be done when the root cause of the problem has been established
58
In CAPA, what are preventative actions?
Addresses the cause of a potential deviation and prevent occurrence in other areas or processes.
59
Give examples of remidial, corrective, and preventative actions that may be carried out when a HPLC system in a QC lab has a leak.
``` • Remedial Action - Switch pump off, and tighten up loose nut • Corrective Action - Replace nut with a locking nut • Preventive Action - Do this with the other systems in your own laboratory - Contact other QC laboratories with the same HPLC system to replace nuts with locking nuts. ```
60
What is root cause analysis?
Root Cause Analysis is pivotal in identifying the corrective and preventive actions • Enables the operator to find the TRUE cause of the the problem, to CORRECT it and to PREVENT it from happening again Root Cause Analysis is the proper investigation of a deviation or out of specification result using defined tools in order to find the true reason for why the deviation / out of specification result occurred.
61
What are the two main steps in root cause analysis?
1. Determining what happened – Defining the Problem | 2. Determining why it happened – Cause and Effect
62
What is the 5 whys method of root cause analysis?
The theory is that if you ask “why” a problem occurred, each time you get an answer, by the time you have asked “why?” five times – you will have got to your root cause.
63
What are the two main methods of determination in root cause analysis?
Fishbone diagrams and the 5 whys method.
64
Define risk.
The combination of the probability of occurrence of harm and the severity of that harm.
65
What is the general quality risk management process?
Quality risk management is a systematic process for the assessment, control, communication, and review of risks to the quality of the medicinal product across the product lifecycle.
66
What are the principles of quality risk management?
Scientific and commensurate.
67
Define the scientific principle of quality risk management.
The evaluation of the risk the quality should be based upon scientific knowledge and ultimately linked to the protection of the patient.
68
Design the commensurate principle of quality risk management.
The level of effort, formality, and documentation of the risk management process should be commensurate (equal) with the level of risk.
69
Why should one bother with quality risk management?
- Improved understanding of your operations. - Protects assets and enhances the image of the organisation. - Optimizes operational efficiency. - Contributes to more effective allocation of resources. - Improves decision making, planning, and prioritisation.
70
What processes does the quality risk management process follow?
Risk assessment (identification, analysis, evaluation), risk control (reduction, acceptance), risk review (acceptance or review events), communication (output results of risk management process).
71
What are the three stages in the risk assessment process?
Identification, analysis, evaluation.
72
How should one analyse risk?
Order the risks and investigate the highest score first.
73
How should one evaluate risk?
Compare the identified and analysed risk against given risk criteria.
74
Risk control aims to reduce or accept the risk, what should be considered?
- Is the risk above an acceptable level? - What can be done to reduce or eliminate risks? - What is the appropriate balance among benefits, risks, and resources? - Are new risks introduces as a result of the identified risks being controlled?
75
What is risk communication?
Sharing information about risks and risk management between decision-makers and stakeholders. This can occur at any stage in the process and must include all interested parties.
76
What can risk communication include?
Training programmes, use of colour, use of psychology.
77
Explain risk review.
A mechanism to review or monitor events should be implemented. The frequency of review should be based upon the risk.
78
What is an audit?
An audit is a key tool in maintaining standards and quality improvements. A part of the overall QA system. Allows determination of compliance with current good practice (cGXP), legal requirements, license commitments.
79
What does the community pharmacy contract state about audit requirements?
Each community pharmacy is required to carry out at least two audits per year.
80
What did the government white paper (1989) state about audits?
An effective programme of audit will help to provide the necessary reassurance to doctors, patients, and managers that the best quality of service is being achieved within the resources available.
81
What is the audit cycle?
Audit planning and design, set standards, collect data, evaluate performance, make changes, monitor the effects of changes, repeat from setting standards.
82
Why should one audit processes?
Maintenance of standards, benchmarking, measurement of improvement, sanity check, identify weaknesses and strengths, build confidence in the QA system, assess the risk to the patient. Because it is required by GXP, shows standards are met, improve the outcome for patients.
83
What is a third party audit?
An audit undertaken by staff not managerially accountable within the corporate structure, independent of any service provision to the unit.
84
What types of audit are there?
Third party audits, second party audits, first-party audits (Internal), horizontal audit, vertical audit.
85
What is a second party audit?
When a company performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract.
86
What is a first party audit (internal - self-inspection)?
Conducted in an independent and detailed way by a designated competent person(s) from within the company. Monitors the implementation and compliance with GMP principles and to propose necessary corrective measures.
87
What is a horizontal audit?
A good way to get a feel of the site and its problems. More of a general approach. Follow a process throughout, systematically.
88
What is a vertical audit?
A deeper focus into a specific area or topic. A good way to help identify the severity of a specific issue. Can be time-consuming. One needs to know when to stop.

Pharmaceutical Technology (3rd Year) (3 decks)

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