Module - Quality Assurance and Quality Control 2 (SPE222)

STP

Aim of this module

This module will enable the trainee to consolidate their experience of the systems and processes that contribute to the provision of high-quality, safe clinical pharmaceutical services and apply their knowledge in a clinical setting. This module provides the trainee with the knowledge that underpins the specialist module in the practice of Clinical Pharmaceutical Science and provides the  trainee with the knowledge and understanding that underpins and is applied to work based learning.

Work-based learning outcomes


  1. Lead an internal or participate in an external audit to ensure that processes are in compliance with requirements to provide a safe product in the setting of a quality system.
  2. Identify specific quality control functions that feed in to the quality management system to provide assurance that all activities within the unit are adequately controlled to provide valid and reliable results to allow for safe release of product(s).
  3. Perform a range of chemical analytical techniques that provide evidence of product quality to ensure that samples/products meet the agreed specifications analysing, interpreting, reporting and acting on the results.
  4. Perform a range of microbiological techniques to assist in providing evidence of product and facility compliance and analyse, interpret and report the test results.
  5. Obtain samples, perform a range of measurements, analyse, interpret and report data to contribute to the sampling requirements process as part of quality control testing.

Work-based Competencies


Learning outcome Title Knowledge
1 1,2,3,4,5

Perform a range of processes and procedures in accordance with laboratory health and safety guidelines to ensure that safe working practices and a safe environment are maintained.

  • Local procedures and controls in place.
  • Standard operating procedures.
  • Safe systems of work.
  • Health & Safety Executive (HSE) limits for occupational exposure.
  • Regulations for exhaust, environmental release.
  • Disposal of hazardous waste.
  • Ability to interpret data given by suppliers and develop local guidelines/procedures for the safe use of chemicals.
2 1

Use personal protective equipment (PPE), Material Safety Data Sheets (MSDS) and Control of Substances Hazardous to Health (COSHH) risk assessments.

  • When and how to use personal protective equipment.
  • Purpose and use of Material Safety Data Sheets (MSDS).
  • Purpose and use of Control of Substances Hazardous to Health.
  • Control of Substances Hazardous to Health regulations and their application in clinical pharmaceutical sciences.
3 1

Write a Control of Substances Hazardous to Health risk assessment for a laboratory reagent used in your unit, ensuring it is used as part of the health and safety practice of the unit, storing the assessment appropriately.

  • How to write a Control of Substances Hazardous to Health risk assessment.
  • Storage, updating and archiving of Control of Substances Hazardous to Health risk assessments.
4 1

Identify the subject area and plan the audit, ensuring the necessary permissions are in place.

  • Regulatory requirements to carry out external audit.
  • Different external customers and risks involved.
  • How to identify a suitable audit topic and current practice.
  • How to identify and classify deficiencies.
  • Services supplied and the impact on patient groups of deficiencies in the service.
  • How to identify a topic area, gain the necessary approval and perform the audit.
  • Stages in the audit process.
  • Criteria for an appropriate area of study and associated standards.
  • Ethical considerations, including confidentiality.
5 1

Undertake/participate in the audit.

  • Regulatory requirements to carry out external audit.
  • Different external customers and risks involved.
  • How to identify a suitable audit topic and current practice.
  • How to identify and classify deficiencies.
  • Services supplied and the impact on patient groups of deficiencies in the service.
  • How to identify a topic area, gain the necessary approval and perform the audit.
  • Stages in the audit process.
  • Criteria for an appropriate area of study and associated standards.
  • Ethical considerations, including confidentiality.
6 1

Analyse and interpret the data from the audit and prepare a written report, including an action plan.

  • The sources of information needed for governance and audit, including access to appropriate evidence-based information.
  • Statistical analysis and interpretation.
  • Options appraisal.
  • Report writing.
7 1

Present the findings from a clinical audit to an audience of peers.

  • How internal and external audit contributes to clinical governance, improving overall clinical practice, personal clinical practice and performance, and, if applicable, reaccreditation.
  • Summarising, evaluating, appraising and presenting information/evidence.
  • How to respond to questions.
8 2

Perform an out-of-specification investigation (OOS) and present findings.

  • How to identify the major parts of a quality management system.
  • Regulatory requirements for out-of-specification (OOS) results.
  • Reporting processes.
  • How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
  • Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
  • The importance of method validation, with respect to quality assurance and suitability of testing.
  • Why equipment validation is necessary.
  • How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
  • How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
  • Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
  • Interpretation of the data from a PQR and recommendations on required changes/developments.
  • How the information is passed on to the relevant parties.
  • Trend analyses of the control of the product.
  • How a recommendation is made to improve a product from a PQR.
  • The actions carried out after a PQR has been completed.
9 2

Evaluate how that OOS result could affect the safety and efficacy of the product tested.

  • How to identify the major parts of a quality management system.
  • Regulatory requirements for out-of-specification (OOS) results.
  • Reporting processes.
  • How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
  • Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
  • The importance of method validation, with respect to quality assurance and suitability of testing.
  • Why equipment validation is necessary.
  • How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
  • How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
  • Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
  • Interpretation of the data from a PQR and recommendations on required changes/developments.
  • How the information is passed on to the relevant parties.
  • Trend analyses of the control of the product.
  • How a recommendation is made to improve a product from a PQR.
  • The actions carried out after a PQR has been completed.
10 2

Identify the critical individual steps required for analytical method validation and revalidation requirements.

  • How to identify the major parts of a quality management system.
  • Regulatory requirements for out-of-specification (OOS) results.
  • Reporting processes.
  • How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
  • Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
  • The importance of method validation, with respect to quality assurance and suitability of testing.
  • Why equipment validation is necessary.
  • How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
  • How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
  • Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
  • Interpretation of the data from a PQR and recommendations on required changes/developments.
  • How the information is passed on to the relevant parties.
  • Trend analyses of the control of the product.
  • How a recommendation is made to improve a product from a PQR.
  • The actions carried out after a PQR has been completed.
11 2

Perform an analytical method validation.

  • How to identify the major parts of a quality management system.
  • Regulatory requirements for out-of-specification (OOS) results.
  • Reporting processes.
  • How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
  • Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
  • The importance of method validation, with respect to quality assurance and suitability of testing.
  • Why equipment validation is necessary.
  • How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
  • How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
  • Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
  • Interpretation of the data from a PQR and recommendations on required changes/developments.
  • How the information is passed on to the relevant parties.
  • Trend analyses of the control of the product.
  • How a recommendation is made to improve a product from a PQR.
  • The actions carried out after a PQR has been completed.
12 2

Identify the critical individual steps required for equipment validation and revalidation requirements.

  • How to identify the major parts of a quality management system.
  • Regulatory requirements for out-of-specification (OOS) results.
  • Reporting processes.
  • How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
  • Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
  • The importance of method validation, with respect to quality assurance and suitability of testing.
  • Why equipment validation is necessary.
  • How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
  • How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
  • Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
  • Interpretation of the data from a PQR and recommendations on required changes/developments.
  • How the information is passed on to the relevant parties.
  • Trend analyses of the control of the product.
  • How a recommendation is made to improve a product from a PQR.
  • The actions carried out after a PQR has been completed.
13 2

Produce a product quality review report.

  • How to identify the major parts of a quality management system.
  • Regulatory requirements for out-of-specification (OOS) results.
  • Reporting processes.
  • How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
  • Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
  • The importance of method validation, with respect to quality assurance and suitability of testing.
  • Why equipment validation is necessary.
  • How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
  • How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
  • Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
  • Interpretation of the data from a PQR and recommendations on required changes/developments.
  • How the information is passed on to the relevant parties.
  • Trend analyses of the control of the product.
  • How a recommendation is made to improve a product from a PQR.
  • The actions carried out after a PQR has been completed.
14 2

Evaluate continuing compliance and highlight any risks to patient or quality assurance.

  • How to identify the major parts of a quality management system.
  • Regulatory requirements for out-of-specification (OOS) results.
  • Reporting processes.
  • How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
  • Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
  • The importance of method validation, with respect to quality assurance and suitability of testing.
  • Why equipment validation is necessary.
  • How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
  • How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
  • Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
  • Interpretation of the data from a PQR and recommendations on required changes/developments.
  • How the information is passed on to the relevant parties.
  • Trend analyses of the control of the product.
  • How a recommendation is made to improve a product from a PQR.
  • The actions carried out after a PQR has been completed.
15 2

Interpret quality control data to enable product release, and if appropriate release product.

  • How to identify the major parts of a quality management system.
  • Regulatory requirements for out-of-specification (OOS) results.
  • Reporting processes.
  • How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
  • Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
  • The importance of method validation, with respect to quality assurance and suitability of testing.
  • Why equipment validation is necessary.
  • How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
  • How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
  • Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
  • Interpretation of the data from a PQR and recommendations on required changes/developments.
  • How the information is passed on to the relevant parties.
  • Trend analyses of the control of the product.
  • How a recommendation is made to improve a product from a PQR.
  • The actions carried out after a PQR has been completed.
16 3

Perform high-performance liquid chromatography (HPLC).

  • How to ensure that samples/products meet the agreed specifications.
  • Calibration, maintenance procedures, etc.
  • Suitability of instrument.
  • System suitability requirements/precision/detection limits etc.
  • Principles of the techniques used.
  • Use the appropriate documentation, e.g. SOPs, worksheets, laboratory information management systems (LIMS).
  • Data security, clinical governance, confidentiality, etc.
  • Testing requirements for a range of product types: raw materials, finished products, stability samples, other samples.
  • Limitation of technique, product characteristics analysed by technique.
  • Techniques and instrumentation.
  • Volumetric analysis – aqueous and non-aqueous.
  • Identification tests, test tube reactions, limit tests.
  • Gravimetric analysis.
  • Refractometry.
  • Melting point.
  • Polarimetry.
  • Spectroscopy – ultraviolet (UV)/visible.
  • Spectroscopy – infrared (IR).
  • Spectroscopy – atomic absorption.
  • Electrochemistry/pH.
  • Particulate measurement, liquids.
  • Solid dose forms, physical testing methods (e.g. hardness, friability, disintegration; theoretical only).
  • Dissolution (theoretical only).
  • Thin-layer chromatography (TLC).
  • High-performance liquid chromatography (HPLC).
  • Gas chromatography.
  • Ion separation chromatography.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
17 3

Perform various spectroscopic techniques, interpret and report the analytical outputs.

  • How to ensure that samples/products meet the agreed specifications.
  • Calibration, maintenance procedures, etc.
  • Suitability of instrument.
  • System suitability requirements/precision/detection limits etc
  • Principles of the techniques used.
  • Use the appropriate documentation, e.g. SOPs, worksheets, laboratory information management systems (LIMS).
  • Data security, clinical governance, confidentiality, etc.
  • Testing requirements for a range of product types: raw materials, finished products, stability samples, other samples.
  • Limitation of technique, product characteristics analysed by technique.
  • Techniques and instrumentation.
  • Volumetric analysis – aqueous and non-aqueous.
  • Identification tests, test tube reactions, limit tests.
  • Gravimetric analysis.
  • Refractometry.
  • Melting point.
  • Polarimetry.
  • Spectroscopy – ultraviolet (UV)/visible.
  • Spectroscopy – infrared (IR).
  • Spectroscopy – atomic absorption.
  • Electrochemistry/pH.
  • Particulate measurement, liquids.
  • Solid dose forms, physical testing methods (e.g. hardness, friability, disintegration; theoretical only).
  • Dissolution (theoretical only).
  • Thin-layer chromatography (TLC).
  • High-performance liquid chromatography (HPLC).
  • Gas chromatography.
  • Ion separation chromatography.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
18 3

Perform pH measurement, interpret and report the analytical outputs.

  • How to ensure that samples/products meet the agreed specifications.
  • Calibration, maintenance procedures, etc.
  • Suitability of instrument.
  • System suitability requirements/precision/detection limits etc.
  • Principles of the techniques used.
  • Use the appropriate documentation, e.g. SOPs, worksheets, laboratory information management systems (LIMS).
  • Data security, clinical governance, confidentiality, etc.
  • Testing requirements for a range of product types: raw materials, finished products, stability samples, other samples.
  • Limitation of technique, product characteristics analysed by technique.
  • Techniques and instrumentation.
  • Volumetric analysis – aqueous and non-aqueous.
  • Identification tests, test tube reactions, limit tests.
  • Gravimetric analysis.
  • Refractometry.
  • Melting point.
  • Polarimetry.
  • Spectroscopy – ultraviolet (UV)/visible.
  • Spectroscopy – infrared (IR).
  • Spectroscopy – atomic absorption.
  • Electrochemistry/pH.
  • Particulate measurement, liquids.
  • Solid dose forms, physical testing methods (e.g. hardness, friability, disintegration; theoretical only).
  • Dissolution (theoretical only).
  • Thin-layer chromatography (TLC).
  • High-performance liquid chromatography (HPLC).
  • Gas chromatography.
  • Ion separation chromatography.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
19 3

Perform volumetric analysis, interpret and report the analytical outputs.

  • How to ensure that samples/products meet the agreed specifications.
  • Calibration, maintenance procedures, etc.
  • Suitability of instrument.
  • System suitability requirements/precision/detection limits etc
  • Principles of the techniques used.
  • Use the appropriate documentation, e.g. SOPs, worksheets, laboratory information management systems (LIMS).
  • Data security, clinical governance, confidentiality, etc.
  • Testing requirements for a range of product types: raw materials, finished products, stability samples, other samples.
  • Limitation of technique, product characteristics analysed by technique.
  • Techniques and instrumentation.
  • Volumetric analysis – aqueous and non-aqueous.
  • Identification tests, test tube reactions, limit tests.
  • Gravimetric analysis.
  • Refractometry.
  • Melting point.
  • Polarimetry.
  • Spectroscopy – ultraviolet (UV)/visible.
  • Spectroscopy – infrared (IR).
  • Spectroscopy – atomic absorption.
  • Electrochemistry/pH.
  • Particulate measurement, liquids.
  • Solid dose forms, physical testing methods (e.g. hardness, friability, disintegration; theoretical only).
  • Dissolution (theoretical only).
  • Thin-layer chromatography (TLC).
  • High-performance liquid chromatography (HPLC).
  • Gas chromatography.
  • Ion separation chromatography.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
20 3

Perform identification tests analysis and interpret and report the analytical outputs.

  • How to ensure that samples/products meet the agreed specifications.
  • Calibration, maintenance procedures, etc.
  • Suitability of instrument.
  • System suitability requirements/precision/detection limits etc
  • Principles of the techniques used.
  • Use the appropriate documentation, e.g. SOPs, worksheets, laboratory information management systems (LIMS).
  • Data security, clinical governance, confidentiality, etc.
  • Testing requirements for a range of product types: raw materials, finished products, stability samples, other samples.
  • Limitation of technique, product characteristics analysed by technique.
  • Techniques and instrumentation.
  • Volumetric analysis – aqueous and non-aqueous.
  • Identification tests, test tube reactions, limit tests.
  • Gravimetric analysis.
  • Refractometry.
  • Melting point.
  • Polarimetry.
  • Spectroscopy – ultraviolet (UV)/visible.
  • Spectroscopy – infrared (IR).
  • Spectroscopy – atomic absorption.
  • Electrochemistry/pH.
  • Particulate measurement, liquids.
  • Solid dose forms, physical testing methods (e.g. hardness, friability, disintegration; theoretical only).
  • Dissolution (theoretical only).
  • Thin-layer chromatography (TLC).
  • High-performance liquid chromatography (HPLC).
  • Gas chromatography.
  • Ion separation chromatography.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
21 3

Perform, interpret and report on a range of other chemical techniques used to ensure that samples/products meet the agreed specifications appropriate to your unit.

  • How to ensure that samples/products meet the agreed specifications.
  • Calibration, maintenance procedures, etc.
  • Suitability of instrument.
  • System suitability requirements/precision/detection limits etc
  • Principles of the techniques used.
  • Use the appropriate documentation, e.g. SOPs, worksheets, laboratory information management systems (LIMS).
  • Data security, clinical governance, confidentiality, etc.
  • Testing requirements for a range of product types: raw materials, finished products, stability samples, other samples.
  • Limitation of technique, product characteristics analysed by technique.
  • Techniques and instrumentation.
  • Volumetric analysis – aqueous and non-aqueous.
  • Identification tests, test tube reactions, limit tests.
  • Gravimetric analysis.
  • Refractometry.
  • Melting point.
  • Polarimetry.
  • Spectroscopy – ultraviolet (UV)/visible.
  • Spectroscopy – infrared (IR).
  • Spectroscopy – atomic absorption.
  • Electrochemistry/pH.
  • Particulate measurement, liquids.
  • Solid dose forms, physical testing methods (e.g. hardness, friability, disintegration; theoretical only).
  • Dissolution (theoretical only).
  • Thin-layer chromatography (TLC).
  • High-performance liquid chromatography (HPLC).
  • Gas chromatography.
  • Ion separation chromatography.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
22 4

Perform a range of environmental monitoring procedures, including physical and microbiological techniques.

  • How you would devise an environmental monitoring programme.
  • Validation of sterility testing, positive and negative controls, local procedures.
  • Difference between microbiology in clinical and pharmaceutical microbiology.
  • Sampling sizes for microbial monitoring – air sampling/sterility test, etc.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
  • Sample handling.
23 4

Analyse the results from environmental monitoring to identify trends and determine the statistical importance/significance of results.

  • How you would devise an environmental monitoring programme.
  • Validation of sterility testing, positive and negative controls, local procedures.
  • Difference between microbiology in clinical and pharmaceutical microbiology.
  • Sampling sizes for microbial monitoring – air sampling/sterility test, etc.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
  • Sample handling.
24 4

Produce a written report in the required format and present your findings at a departmental meeting.

  • How you would devise an environmental monitoring programme.
  • Validation of sterility testing, positive and negative controls, local procedures.
  • Difference between microbiology in clinical and pharmaceutical microbiology.
  • Sampling sizes for microbial monitoring – air sampling/sterility test, etc.
  • Endotoxin and pyrogen testing.
  • Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
  • Sample handling.
25 4

Perform a range of microbiological techniques, including:

  • operator, tests universal broth transfer
  • finger dabs/contact plates, etc.
  • Gram stain/species tests
  • sterility testing
  • total viable count
  • endotoxins
  • broth fills.
  • simple organism identification.
  • Temperature monitoring/temperature mapping, etc.
  • Trend analysis.
  • Justification of testing methods.
  • Structure of written reports.
  • Presentation skills: planning, time keeping, visual aids, communication, active learning, questioning.
26 4

Analyse the results from microbiological testing to identify trends and determine the statistical importance/significance of results.

  • Temperature monitoring/temperature mapping, etc.
  • Trend analysis.
  • Justification of testing methods.
  • Structure of written reports.
  • Presentation skills: planning, time keeping, visual aids, communication, active learning, questioning.
27 4

Produce a written report in the required format and present your findings at a departmental meeting.

  • Temperature monitoring/temperature mapping, etc.
  • Trend analysis.
  • Justification of testing methods.
  • Structure of written reports.
  • Presentation skills: planning, time keeping, visual aids, communication, active learning, questioning.
28 5

Use appropriate sampling plans and strategies to obtain samples.

  • Sample sizes.
  • Statistical sampling methods.
  • Acceptance quality limit (AQL), military standards, Good Manufacturing Practice.
  • Sample types: in-process, prospective, retrospective, stability.
  • Testing implications on sample integrity.
  • Lifetime of the product: transport, identification, cold chain, security, disposal, retention of samples.
29 5

Perform a range of measurements for quality control analysis.

  • Sample sizes.
  • Statistical sampling methods.
  • Acceptance quality limit (AQL), military standards, Good Manufacturing Practice.
  • Sample types: in-process, prospective, retrospective, stability.
  • Testing implications on sample integrity.
  • Lifetime of the product: transport, identification, cold chain, security, disposal, retention of samples.
30 5

Analyse, interpret and report data from each measurement.

  • Sample sizes.
  • Statistical sampling methods.
  • Acceptance quality limit (AQL), military standards, Good Manufacturing Practice.
  • Sample types: in-process, prospective, retrospective, stability.
  • Testing implications on sample integrity.
  • Lifetime of the product: transport, identification, cold chain, security, disposal, retention of samples.
31 5

Critically evaluate how different sampling strategies and methods contribute to quality control within a quality environment, producing a short report to influence future practice.

  • Sample sizes.
  • Statistical sampling methods.
  • Acceptance quality limit (AQL), military standards, Good Manufacturing Practice.
  • Sample types: in-process, prospective, retrospective, stability.
  • Testing implications on sample integrity.
  • Lifetime of the product: transport, identification, cold chain, security, disposal, retention of samples.

Work-based assessment


Complete 3 Case-Based Discussion(s)
Complete 2 of the following DOPS and/or OCEs
Type Title
DOPS Devise a protocol for stability testing a product and perform preliminary and the first analysis of this product
DOPS Identify an SOP in a GMP area that is in need of updating and use the change control procedure to implement the necessary changes
DOPS Determine allocation of appropriate storage conditions and shelf lives
OCE Discuss how you would approach stability studies for both new manufactured products and new aseptically dispensed products
OCE Investigate and map the management of documentation systems within a GMP area. Challenge the archiving recall procedure to find production documentation relating to a historical product from 5 years ago.