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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Interpret preservative efficacy test results.

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