Module - Quality Assurance and Quality Control 1 (SPE200)

STP

Aim of this module

This rotation will enable trainees to gain skills and experience of regulation and quality assurance, and apply underpinning knowledge through introduction to the practice of regulation and quality assurance in a pharmacy. Trainees will gain experience to be able to observe, assist with, or perform a range of routine procedures in the context of providing high-quality, safe patient care and will be expected to develop and build their professional practice.

Work-based learning outcomes


  1. Perform a pharmaceutical development and formulation exercise to meet the clinical needs of a particular patient product. 
  2. Use and critically review a quality management system. 
  3. Perform pharmacovigilance risk assessments. 
  4. Assist in and evaluate internal and external auditing of suppliers and/or contract manufacturers. 
  5. Use a change control system to document a change to a product, facility, or controlled documentation. 
  6. Identify and speciate microorganisms using a variety of techniques. 
  7. Interpret preservative efficacy test results. 

Work-based Competencies


Learning outcome Title Knowledge
1 1

Meet with the user and prepare a technical agreement that meets the needs of the user.

  • Regulatory aspects. Different licence types.
  • Major dosage forms.
  • Interaction between excipients and active pharmaceutical ingredients (API).
  • The function of the excipient.
  • Accelerated stability testing.
  • Factors around absorption of active pharmaceutical ingredients and ways of addressing the challenges.
  • Clinical trials (overview).
  • Governance issues ethics.
  • Patient use.
  • Quality assurance.
  • Documentation and records:
    • quality assurance/control documentation
    • manufacturing documentation.
  • Document design.
  • Manufacturing authorisation application.
2 1

Write a product specification that addresses user requirements.

  • Regulatory aspects. Different licence types.
  • Major dosage forms.
  • Interaction between excipients and active pharmaceutical ingredients (API).
  • The function of the excipient.
  • Accelerated stability testing.
  • Factors around absorption of active pharmaceutical ingredients and ways of addressing the challenges.
  • Clinical trials (overview).
  • Governance issues ethics.
  • Patient use.
  • Quality assurance.
  • Documentation and records:
    • quality assurance/control documentation
    • manufacturing documentation.
  • Document design.
  • Manufacturing authorisation application.
3 1

Assemble a prototype product.

  • Regulatory aspects. Different licence types.
  • Major dosage forms.
  • Interaction between excipients and active pharmaceutical ingredients (API).
  • The function of the excipient.
  • Accelerated stability testing.
  • Factors around absorption of active pharmaceutical ingredients and ways of addressing the challenges.
  • Clinical trials (overview).
  • Governance issues ethics.
  • Patient use.
  • Quality assurance.
  • Documentation and records:
    • quality assurance/control documentation
    • manufacturing documentation.
  • Document design.
  • Manufacturing authorisation application.
4 1

Perform product compatibility and stability testing against the specification.

  • Regulatory aspects. Different licence types.
  • Major dosage forms.
  • Interaction between excipients and active pharmaceutical ingredients (API).
  • The function of the excipient.
  • Accelerated stability testing.
  • Factors around absorption of active pharmaceutical ingredients and ways of addressing the challenges.
  • Clinical trials (overview).
  • Governance issues ethics.
  • Patient use.
  • Quality assurance.
  • Documentation and records:
    • quality assurance/control documentation
    • manufacturing documentation.
  • Document design.
  • Manufacturing authorisation application.
5 1

Review the results and compare against specification.

  • Regulatory aspects. Different licence types.
  • Major dosage forms.
  • Interaction between excipients and active pharmaceutical ingredients (API).
  • The function of the excipient.
  • Accelerated stability testing.
  • Factors around absorption of active pharmaceutical ingredients and ways of addressing the challenges.
  • Clinical trials (overview).
  • Governance issues ethics.
  • Patient use.
  • Quality assurance.
  • Documentation and records:
    • quality assurance/control documentation
    • manufacturing documentation.
  • Document design.
  • Manufacturing authorisation application.
6 2

Review a quality management system (QMS) to ensure compliance with Good Manufacturing Practice (GMP) or equivalent.

  • Structure of quality management systems.
  • Quality assurance:
    • Good Manufacturing Practice
    • Good Clinical Practice
    • Good Scientific Practice.
  • The role of the qualified person.
  • Different authorisation types, different requirements for product quality assurance and release of products.
  • Quality system review.
  • BS5750 – ISO 9000, etc.
  • Laboratory of Government Chemist (LGC) and 
  • Pharmassure schemes of intra-laboratory quality assurance.
  • Governance and controls assurance, risk management and critical point control analysis.
  • United Kingdom Accreditation Service (UKAS).
7 2

Write a report identifying areas of good practice and recommending changes, if appropriate, to resolve issues identified.

  • Report writing.
  • Roles and responsibilities.
  • Systems for developing and adopting policy.
8 2

Present the findings of your quality management system review to members of the department.

  • Planning and delivering an oral presentation.
  • Producing supporting material, for example PowerPoint.
  • Barriers to effective communication.
  • How to give an effective and timely oral presentation.
  • How to respond to questioning.
9 3

Identify a potential risk and perform a pharmacovigilance risk assessment.

  • Purpose of pharmacovigilance risk assessment.
  • Committee for Medicinal Products for Human Use.
  • Detection, assessment, minimisation and communication relating to the risk of adverse reactions.
  • Therapeutic effect of the medicinal product.
  • The design and evaluation of post-authorisation safety studies.
  • How to perform pharmacovigilance risk assessment and audit:
    • risk identification
    • risk measurement
    • analysis and evaluation (risk benefit evaluation)
    • risk management
    • monitoring the effect of risk management.
  • Correct level of approval/authorisation.
  • Monitoring clinical outcomes, positive and adverse drug reactions (ADR).
  • Reporting any adverse drug reactions.
  • Summary of product characteristics (SmPC), including likely frequency and severity of adverse drug reactions.
  • Reporting mechanisms within and beyond your organisation.
10 3

Write up the findings of the risk assessment as a formal report and present the findings to an internal meeting, including an action plan.

  • Purpose of pharmacovigilance risk assessment.
  • Committee for Medicinal Products for Human Use.
  • Detection, assessment, minimisation and communication relating to the risk of adverse reactions.
  • Therapeutic effect of the medicinal product.
  • The design and evaluation of post-authorisation safety studies.
  • How to perform pharmacovigilance risk assessment and audit:
    • risk identification
    • risk measurement
    • analysis and evaluation (risk benefit evaluation)
    • risk management
    • monitoring the effect of risk management.
  • Correct level of approval/authorisation.
  • Monitoring clinical outcomes, positive and adverse drug reactions (ADR).
  • Reporting any adverse drug reactions.
  • Summary of product characteristics (SmPC), including likely frequency and severity of adverse drug reactions.
  • Reporting mechanisms within and beyond your organisation.
11 4

Plan and prepare for an internal or external audit of suppliers and/or contract manufacturers.

  • Literature searching.
  • Purpose of pharmacovigilance audit.
  • Medicines and Healthcare products Regulatory Agency (MHRA) Good Pharmacovigilance Practice.
  • Audit cycle.
  • National guidelines for pharmaceutical quality audits.
  • Purpose of purchasing for safety.
  • Mechanisms underpinning the audit, including rectification, audit, monitoring.
  • Corrective and preventive action.
  • Report writing.
  • Presentation skills.
12 4

Assist in performing an internal or external audit of suppliers and/or contract manufacturers.

  • Literature searching.
  • Purpose of pharmacovigilance audit.
  • Medicines and Healthcare products Regulatory Agency (MHRA) Good Pharmacovigilance Practice.
  • Audit cycle.
  • National guidelines for pharmaceutical quality audits.
  • Purpose of purchasing for safety.
  • Mechanisms underpinning the audit, including rectification, audit, monitoring.
  • Corrective and preventive action.
  • Report writing.
  • Presentation skills.
13 4

Write up the findings of the audit as a report and present the findings to an internal meeting, including an action plan and if possible ensure closure of the audit cycle.

  • Literature searching.
  • Purpose of pharmacovigilance audit.
  • Medicines and Healthcare products Regulatory Agency (MHRA) Good Pharmacovigilance Practice.
  • Audit cycle.
  • National guidelines for pharmaceutical quality audits.
  • Purpose of purchasing for safety.
  • Mechanisms underpinning the audit, including rectification, audit, monitoring.
  • Corrective and preventive action.
  • Report writing.
  • Presentation skills.
14 5

Identify shortcomings in existing procedure and recommend change following assisting and writing up of an audit. 

  • Purpose of change management to manage change to prevent unintended consequences.
  • Effective change control activities:
    • quality planning and control of revisions to specifications
    • process parameters
    • procedures.
  • Responsibilities of the quality control unit.
  • Regulatory approval processes.
  • Local governance.
  • Standard operating procedures.
15 5

Assess the impact of the change in your recommendation following assisting and writing up of an audit. 

  • Purpose of change management to manage change to prevent unintended consequences.
  • Effective change control activities:
    • quality planning and control of revisions to specifications
    • process parameters
    • procedures.
  • Responsibilities of the quality control unit.
  • Regulatory approval processes.
  • Local governance.
  • Standard operating procedures.
16 5

Gain approval to implement (or not) your changes following assisting and writing up of an audit. 

  • Purpose of change management to manage change to prevent unintended consequences.
  • Effective change control activities:
    • quality planning and control of revisions to specifications
    • process parameters
    • procedures.
  • Responsibilities of the quality control unit.
  • Regulatory approval processes.
  • Local governance.
  • Standard operating procedures.
17 5

Re-evaluate the process previously audited.

  • Purpose of change management to manage change to prevent unintended consequences.
  • Effective change control activities:
    • quality planning and control of revisions to specifications
    • process parameters
    • procedures.
  • Responsibilities of the quality control unit.
  • Regulatory approval processes.
  • Local governance.
  • Standard operating procedures.
18 6

Identify and speciate microorganisms using a variety of techniques.

  • How to use a microscope.
  • How to undertake gram staining and use API strips.
  • Identification of common organisms.
19 7

Interpret preservative efficacy test results.

  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.

Work-based assessment


Complete 1 Case-Based Discussion(s)
Complete 1 of the following DOPS and/or OCEs
Type Title
DOPS Observe maintenance and testing of filtered air systems
DOPS Monitor temperature and conditions of storage areas of medicines and report on any out of limits results
DOPS Determine allocation of appropriate storage conditions and shelf lives
DOPS Introduce a new changing procedure
DOPS Identify a procedure in need of updating and change it
OCE Prepare and run a multidisciplinary team meeting