Quality Assurance and Quality Control 2

Module details

Title

Quality Assurance and Quality Control 2

Type

Specialist

Module code

SPE222

Credits

10

Requirement

Compulsory

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.

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1,2,3,4,5	Competency 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.	Action View
# 2	Learning outcome 1	Competency Use personal protective equipment (PPE), Material Safety Data Sheets (MSDS) and Control of Substances Hazardous to Health (COSHH) risk assessments.	Action View
# 3	Learning outcome 1	Competency 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.	Action View
# 4	Learning outcome 1	Competency Identify the subject area and plan the audit, ensuring the necessary permissions are in place.	Action View
# 5	Learning outcome 1	Competency Undertake/participate in the audit.	Action View
# 6	Learning outcome 1	Competency Analyse and interpret the data from the audit and prepare a written report, including an action plan.	Action View
# 7	Learning outcome 1	Competency Present the findings from a clinical audit to an audience of peers.	Action View
# 8	Learning outcome 2	Competency Perform an out-of-specification investigation (OOS) and present findings.	Action View
# 9	Learning outcome 2	Competency Evaluate how that OOS result could affect the safety and efficacy of the product tested.	Action View
# 10	Learning outcome 2	Competency Identify the critical individual steps required for analytical method validation and revalidation requirements.	Action View
# 11	Learning outcome 2	Competency Perform an analytical method validation.	Action View
# 12	Learning outcome 2	Competency Identify the critical individual steps required for equipment validation and revalidation requirements.	Action View
# 13	Learning outcome 2	Competency Produce a product quality review report.	Action View
# 14	Learning outcome 2	Competency Evaluate continuing compliance and highlight any risks to patient or quality assurance.	Action View
# 15	Learning outcome 2	Competency Interpret quality control data to enable product release, and if appropriate release product.	Action View
# 16	Learning outcome 3	Competency Perform high-performance liquid chromatography (HPLC).	Action View
# 17	Learning outcome 3	Competency Perform various spectroscopic techniques, interpret and report the analytical outputs.	Action View
# 18	Learning outcome 3	Competency Perform pH measurement, interpret and report the analytical outputs.	Action View
# 19	Learning outcome 3	Competency Perform volumetric analysis, interpret and report the analytical outputs.	Action View
# 20	Learning outcome 3	Competency Perform identification tests analysis and interpret and report the analytical outputs.	Action View
# 21	Learning outcome 3	Competency 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.	Action View
# 22	Learning outcome 4	Competency Perform a range of environmental monitoring procedures, including physical and microbiological techniques.	Action View
# 23	Learning outcome 4	Competency Analyse the results from environmental monitoring to identify trends and determine the statistical importance/significance of results.	Action View
# 24	Learning outcome 4	Competency Produce a written report in the required format and present your findings at a departmental meeting.	Action View
# 25	Learning outcome 4	Competency 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.	Action View
# 26	Learning outcome 4	Competency Analyse the results from microbiological testing to identify trends and determine the statistical importance/significance of results.	Action View
# 27	Learning outcome 4	Competency Produce a written report in the required format and present your findings at a departmental meeting.	Action View
# 28	Learning outcome 5	Competency Use appropriate sampling plans and strategies to obtain samples.	Action View
# 29	Learning outcome 5	Competency Perform a range of measurements for quality control analysis.	Action View
# 30	Learning outcome 5	Competency Analyse, interpret and report data from each measurement.	Action View
# 31	Learning outcome 5	Competency Critically evaluate how different sampling strategies and methods contribute to quality control within a quality environment, producing a short report to influence future practice.	Action View

Assessments

You must complete:

• 3 case-based discussion(s)
• 2 of the following DOPS/ OCEs:

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	DOPS
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.	OCE

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.

Learning outcomes

1. Discuss the role of the Clinical Scientist in Pharmaceutical Sciences in ensuring the safety of the patient, particularly related to the manufacture of licensed and unlicensed products and investigational medicinal products (IMPs), with reference to key patient pathways such as cancer.
2. Explain the theory and use of all pharmaceutical microbiological and analytical techniques and instruments in a pharmaceutical quality control laboratory.
3. Discuss the quality of medicinal products, including raw materials, licensed  and unlicensed products, ‘specials’, IMPs, medical and surgical devices, and medical gases.
4. Discuss the responsibilities required for managing a quality assurance system.
5. Discuss the role of quality audits and quality system reviews.
6. Justify the choice of, and apply statistical methods to, sampling and testing.

Indicative content

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 chromatographyIon separation chromatography
• Endotoxin and pyrogen testing (theory)
• Pharmaceutical microbiology     –     sterility     testing,     non-sterile     product microbiology, water systems testing, preservative efficacy testing

The quality control department

• Control of quality and the role of the quality controller
• Unlicensed products and ‘specials’
• Involvement in clinical trials
  • Governance
  • Ethics
  • Quality assurance
  • Monitoring

Product testing

• Purchased medicines
• Raw materials
• Final products

Medical gases

• Range and users of medical gases
• Health Technical Memorandum 02 and permit-to-work system
• Role of ‘quality controller’ in medical gas testing
• On-site testing

Clean room qualification

• Air quality determination
  • Room over-pressures
  • Viable and non-viable particle counts
  • Air flow
  • Air change rate

Statistics

• Application of statistical methods to sampling and testing methods

Activities

• Observe the testing of piped medical gases from a quality control perspective, including purity, identification, impurity identification, particulates, water content, etc., and discuss the system that governs and regulates medical gases handling and use within a health environment (Health Technical Memorandum 02).
• Visit at least two other licensed units (e.g. commercial premises/industrial units) and observe the production and quality control processes that underpin manufacturing and production, and compare and contrast the critical differences.
• Visit a range of clinical environments to observe how finished products that have been tested for quality control and release for patient use are received by the healthcare professional and administered to patients, identifying good practice and areas for improvement by discussing the process with the staff and, with permission, individual patients.
• Observe a range of microbiological sampling and testing methods in a microbiology service and compare and contrast techniques used and work practices with those of the pharmaceutical microbiology department, and produce a short report for discussion with your training officer.
• Observe the planned, preventative and urgent maintenance of equipment used within a clinical pharmaceutical sciences setting and reflect on the contribution of planned and preventative maintenance strategies to quality.
• Use a range of laboratory-based computer systems and analyse how information technology supports the management of workload and data handling.
• Observe and interpret in-process and end product testing for a range of pharmaceutical products.
• Observe the processes involved in the testing and approval of pharmaceutical raw materials and the supplier approval process, and identify the strengths of the processes and areas for improvement.
• Observe the various stages of clinical trials, including all aspects of the role of pharmacy in clinical trials to benefit and improve patient care.