Regulation and Quality Assurance

PHAR61780 Regulation and Quality Assurance 30 Semester 1 Postgraduate Taught Level 7 Ruth Barnes Unit coordinator Mark Oldcorne Unit coordinator Emma Davies Unit coordinator Sue Renn Unit coordinator Pharmacy 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 15.0 Regulatory Aspects:<ul><li>The Medicines Act and its implication to “specials” manufacturing and preparation activities, with particular attention on hospital-based work</li><li>Consolidated Human Medicines Regulations</li><li>The rules governing medicinal products in the European Community</li><li>Environmental Protection Act</li><li>Consumer Protection Act</li><li>EEC Directives</li><li>Statutory Instruments</li><li>Medicines Act leaflets</li><li>Specifications and standards (British Pharmacopoeia, Ph, Eur, etc.)</li><li>Official reports (Farwell, Clothier, Rosenheim etc.) of relevance /importance.</li></ul>Quality Assurance:<ul><li>Quality Assurance, including management and organisational aspects</li><li>Quality Risk Management</li><li>Pharmaceutical Quality Systems</li><li>Quality Audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of Clinical Governances, Controls Assurance standards, Risk Management/Assessment and Critical Point Analysis</li><li>The role of the Qualified Person</li><li>Quality System Review - mention but pick up in more detail in Y2</li><li>Quality Management Standards BS.5750 – ISO 9000 etc.</li><li>Governance and Controls Assurance, Risk Management and Critical Point Control Analysis</li><li>Good Manufacturing Practice (GMP)</li><li>International Good Manufacturing Practice (GMP) guidelines and standards. (ICH)</li><li>Information contained on the SPS website</li><li>Defective products, complaints and recall procedure.</li></ul>Documentation and Records:<ul><li>Quality Assurance / Control Documentation:<ul><li>Standard Operating Procedures (SOPs)</li><li>Specifications/ worksheets/ BMRs</li><li>General laboratory records</li><li>Status labelling systems etc.</li><li>Information Management systems</li><li>Change Control</li><li>Exception/ Variation reporting.</li></ul></li><li>Document Design:<ul><li>Authorisation, control and indexing the documentation</li><li>Updating and version control</li><li>Archiving and alternatives to paper documents</li><li>(Microfilm, Electronic Data Processing) etc.</li></ul></li><li>Introduction to Pharmaceutical Audit:<ul><li>Aims and role of Audit/ definitions</li><li>The Audit Cycle</li><li>Types of Audit, Internal/ External/ Inspection/ Review</li><li>Quality Systems within Pharmacy Services e.g.ISO9002, Specials etc.</li></ul></li></ul> Regulatory Aspects:<ul><li>The Medicines Act and its implication to “specials” manufacturing and preparation activities, with particular attention on hospital-based work</li><li>Consolidated Human Medicines Regulations</li><li>The rules governing medicinal products in the European Community</li><li>Environmental Protection Act</li><li>Consumer Protection Act</li><li>EEC Directives</li><li>Statutory Instruments</li><li>Medicines Act leaflets</li><li>Specifications and standards (British Pharmacopoeia, Ph, Eur, etc.)</li><li>Official reports (Farwell, Clothier, Rosenheim etc.) of relevance /importance.</li></ul>Quality Assurance:<ul><li>Quality Assurance, including management and organisational aspects</li><li>Quality Risk Management</li><li>Pharmaceutical Quality Systems</li><li>Quality Audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of Clinical Governances, Controls Assurance standards, Risk Management/Assessment and Critical Point Analysis</li><li>The role of the Qualified Person</li><li>Quality System Review - mention but pick up in more detail in Y2</li><li>Quality Management Standards BS.5750 – ISO 9000 etc.</li><li>Governance and Controls Assurance, Risk Management and Critical Point Control Analysis</li><li>Good Manufacturing Practice (GMP)</li><li>International Good Manufacturing Practice (GMP) guidelines and standards. (ICH)</li><li>Information contained on the SPS website</li><li>Defective products, complaints and recall procedure.</li></ul>Documentation and Records:<ul><li>Quality Assurance / Control Documentation:<ul><li>Standard Operating Procedures (SOPs)</li><li>Specifications/ worksheets/ BMRs</li><li>General laboratory records</li><li>Status labelling systems etc.</li><li>Information Management systems</li><li>Change Control</li><li>Exception/ Variation reporting.</li></ul></li><li>Document Design:<ul><li>Authorisation, control and indexing the documentation</li><li>Updating and version control</li><li>Archiving and alternatives to paper documents</li><li>(Microfilm, Electronic Data Processing) etc.</li></ul></li><li>Introduction to Pharmaceutical Audit:<ul><li>Aims and role of Audit/ definitions</li><li>The Audit Cycle</li><li>Types of Audit, Internal/ External/ Inspection/ Review</li><li>Quality Systems within Pharmacy Services e.g.ISO9002, Specials etc.</li></ul></li></ul> <ul> <li>The unit provides the background knowledge required by the students undertaking the Pharmaceutical Technology and Quality Assurance (PTQA) programme. Students following different career paths will all require the core knowledge provided by this unit in order to progress through their own choices and to gain an appreciation of alternative routes through the programme.  </li> <li>The unit provides the students with an essential grounding in pharmaceutical quality assurance which underpins all GMP activities. Students will engage with lecturers and reading material to gain a full understanding of the regulatory framework governing pharmaceutical preparation and manufacture within the NHS.  </li> <li>It will also provide a fundamental understanding of Pharmaceutical Quality Systems (PQS) and the operational benefits and challenges of a robust system. The key documents of a PQS will be defined.</li></ul> Students will be able to:<ul><li>Discuss and critically evaluate the application of regulatory controls to pharmaceutical technology and Quality Assurance.</li><li>Discuss and critically evaluate the principles of Quality Assurance (QA) and EU Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems (PQS).</li><li>Evaluate incident reports relating to pharmaceutical preparation and the impact that these have had on pharmacy regulations and guidance.</li><li>Implement the fundamentals of good document design throughout the whole PQS.</li><li>Design and construct manufacturing, Quality Assurance and Quality Control documentation.</li><li>Discuss the health and safety aspects of Pharmaceutical Technology and Quality Assurance.</li><li>Describe the process to be followed when recalling a product from the market.</li><li>Critique the requirements for outsourcing and purchasing of pharmaceutical products.</li></ul> Students will be able to:<ul><li>Follow regulatory standards and guidance.</li><li>Evaluate scientific and clinical literature and present appropriately.</li><li>Critically appraise concepts and measures of quality and quality assurance and their links with the effective and efficient management of resources and improvement of service delivery.</li></ul> Students will be able to:<ul><li>Prepare technical documents; product specifications, investigation reports.</li><li>Prepare risk assessments using a variety of tools and techniques.</li><li>Interpret complex data and report on the findings.</li><li>Prepare for an internal or external audit.</li><li>Identify shortcoming in existing procedure and recommend change.</li><li>Assess the impact of change.</li></ul> Students will be able to:<ul><li>Read, interpret and apply standards and guidance to working practices.</li><li>Demonstrate professionalism and ethical awareness.</li><li>Communicate effectively with professional colleagues and service users.</li><li>Select and apply appropriate analysis or assessment techniques and tools.</li></ul> <ul><li>A teaching block including face-to-face and online lectures and workshops.</li><li>E-learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards.</li></ul> 0 Other 100% <figure class="table"><table><tbody><tr><td style="border:1px solid hsl(0, 0%, 0%);">Assessment task</td><td style="border:1px solid hsl(0, 0%, 0%);">Length</td><td style="border:1px solid hsl(0, 0%, 0%);">How and when feedback is provided</td><td style="border:1px solid hsl(0, 0%, 0%);">Weighting within unit (if relevant)</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Discussion board on the e-learning materials</td><td style="border:1px solid hsl(0, 0%, 0%);">1,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">Formative</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Online e-assessment x5 (One test on the e-learning blocks and then one at the start of each teaching day)</td><td style="border:1px solid hsl(0, 0%, 0%);">15 minutes</td><td style="border:1px solid hsl(0, 0%, 0%);">Online - immediately following quiz</td><td style="border:1px solid hsl(0, 0%, 0%);">Formative</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Online exam</td><td style="border:1px solid hsl(0, 0%, 0%);">1.5 hours</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">40%</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Written assignment (group 4-6)</td><td style="border:1px solid hsl(0, 0%, 0%);">3,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">30%</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Written assignment (individual reflection)</td><td style="border:1px solid hsl(0, 0%, 0%);">1,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">10%</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Presentation (group of 4-6)</td><td style="border:1px solid hsl(0, 0%, 0%);">20 minutes, plus 5 mins questions</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">20%</td></tr></tbody></table></figure> Provisional marks and feedback for coursework returned in 3 weeks after submission deadline.Exam marks and final marks returned after ratification at exam board. MSc PTQA (Pharm Tech & QA) MSc PTQA (Pharm Tech & QA) PGDT Taught Component Mandatory PGD PTQA (Pharm Tech & QA) PGDp PTQA (Pharm Tech & QA) PGDT Taught Component Mandatory PGCert PTQA (Pharm Tech & QA) PGCert PTQA (Pharm Tech & QA) PGDT Taught Component Mandatory N <ol><li>Beaney, A. 2016. Quality Assurance of Aseptic Preparation Services (5th Edition), online at <a href="http://www.rpharms.com/support-pdfs/rps---qaaps-standards-document.pdf">http://www.rpharms.com/support-pdfs/rps---qaaps-standards-document.pdf</a></li><li>EU Legislation - Eudralex, Online at <a href="http://ec.europa.eu/health/documents/eudralex/">http://ec.europa.eu/health/documents/eudralex/</a><ul><li>Volume 1 - EU pharmaceutical legislation for medical products for human use</li><li>Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use</li><li>Volume 3 - Scientific guidelines for medicinal products for human use</li></ul></li><li>Guidelines for good manufacturing practices for medicinal products for human and veterinary use (Volume 4), online at <a href="http://ec.europa.eu/health/documents/eudralex/">http://ec.europa.eu/health/documents/eudralex/</a><ul><li>Chapter 1 – Pharmaceutical Quality System</li><li>Chapter 4 – Documentation</li><li>Chapter 8 – Complaints and Product Recall</li><li>Chapter 9 – Self Inspection</li><li>Part III – GMP related documents<ul><li>Site Master File</li><li>Q9 Quality Risk Management</li><li>Q10 Note for Guidance on Pharmaceutical Quality System </li></ul></li></ul></li><li>Explanatory Memorandum to the Human Medicines Regulations 2012 (2012 No. 1916), online at <a href="http://www.legislation.gov.uk/uksi/2012/1916/pdfs/uksiem_20121916_en.pdf">http://www.legislation.gov.uk/uksi/2012/1916/pdfs/uksiem_20121916_en.pdf</a></li><li>The Human Medicines Regulations 2012 (SI 2012 No. 1916), online at <a href="http://www.legislation.gov.uk/uksi/2012/1916/pdfs/uksi_20121916_en.pdf">http://www.legislation.gov.uk/uksi/2012/1916/pdfs/uksi_20121916_en.pdf</a></li><li>The Medicines Act 1968, online at <a href="http://www.legislation.gov.uk/ukpga/1968/67/pdfs/ukpga_19680067_en.pdf">http://www.legislation.gov.uk/ukpga/1968/67/pdfs/ukpga_19680067_en.pdf</a></li><li>MHRA Guidance Note 14: The supply of unlicensed medicinal products (“specials”), online at <a href="http://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials">http://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials</a></li><li>Thalidomide and its sequelae, online at <a href="http://www.sciencedirect.com/science/article/pii/S0140673612604681">http://www.sciencedirect.com/science/article/pii/S0140673612604681</a></li><li>WHO Quality Assurance of Pharmaceuticals (Volume 2), online at <a href="http://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssuranccePharmVol2.pdf">http://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf</a></li></ol> Lectures 30 0 270 Other schedules teaching and learning activities:<ul><li>Lectures and workshops</li><li>Self-directed study (web-based learning and activities on Blackboard)</li><li>Private study</li><li>Catch-up meetings and online Q&A</li><li>Summative assessment</li><li>Formative assessment.</li></ul>