Introduction to Clinical Pharmaceutical Science 2A

PHAR61790 Introduction to Clinical Pharmaceutical Science 2A 30 Full year Postgraduate Taught Level 7 Ruth Barnes Unit coordinator 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 15.0  Production (10 credits)·         Quality Assurance§  Quality Assurance§  Quality Audits·         Product Design§  Developing a product specification§  Packaging requirements§  Labelling requirements and regulations§  Stability considerations·         Manufacture, Assembly, Preparation and Dispensing§  Solid dose forms§  Liquid oral medicines§  External liquids§  Semi-solids (ointments, creams, gels and pastes)§  Sterile topical liquids§  Irrigations§  Injections and infusions§  Miscellaneous others·         Processes§  Weighing§  Measuring§  Milling§  Mixing§  Filling§  Sealing§  Filtration - clarification/sterilisation·         Sterilisation Methods§  Application of Microbiology to Sterilisation Techniques§  HTM 2010 - Sterilisers§  Sterilisation by moist heat§  Sterilisation by dry heat§  Gaseous sterilisation§  Sterilisation by irradiation·         Pharmaceutical Water§  Water purification and storage§  Pharmaceutical handling and quality§  HTM 2031 – Clean Steam§  HTM 2030 – Washers Aseptics (10 credits) ·         Facilities and equipment·         Principles of aseptic manipulation§  Practical application of quality assurance§  Aseptic technique§  Compliance with regulatory and operational requirements§  Effective working within aseptic processing environments·         Pharmaceutical Microbiology§  Micro-organisms, Microbial growth (form and actions of microbes)§  Sources of microbiological contamination§  Potential risks fr Production (10 credits) ·         Quality Assurance§  Quality Assurance§  Quality Audits·         Product Design§  Developing a product specification§  Packaging requirements§  Labelling requirements and regulations§  Stability considerations·         Manufacture, Assembly, Preparation and Dispensing§  Solid dose forms§  Liquid oral medicines§  External liquids§  Semi-solids (ointments, creams, gels and pastes)§  Sterile topical liquids§  Irrigations§  Injections and infusions§  Miscellaneous others·         Processes§  Weighing§  Measuring§  Milling§  Mixing§  Filling§  Sealing§  Filtration - clarification/sterilisation·         Sterilisation Methods§  Application of Microbiology to Sterilisation Techniques§  HTM 2010 - Sterilisers§  Sterilisation by moist heat§  Sterilisation by dry heat§  Gaseous sterilisation§  Sterilisation by irradiation·         Pharmaceutical Water§  Water purification and storage§  Pharmaceutical handling and quality§  HTM 2031 – Clean Steam§  HTM 2030 – Washers Aseptics (10 credits) ·         Facilities and equipment·         Principles of aseptic manipulation§  Practical application of quality assurance§  Aseptic technique§  Compliance with regulatory and operational requirements§  Effective working within aseptic processing environments·         Pharmaceutical Microbiology§  Micro-organisms, Microbial growth (form and actions of microbes)§  Sources of microbiological contamination§  Potential risks from microbial contamination. (Pathogens and infection risks)§  Spoilage and control / preservation·         Maintenance of essential documentation§  Completion of all logs, worksheets and reports§  Completion of necessary training records Formulation Sciences (10 credits) ·         Pharmaceutical Formulation and Processing§  Sources, preparation and purification of major drug substances and excipients§  Formulation§  Stability studies§  Drug administration systems§  Analytical method development§  Specification development§  Presentation of the product in relation to its method of use and/or administration§  Equipment calibration§  Rational approach to process validation·         Principles of formulation§  Solutions, topical liquids§  Semisolids, creams and ointments,§  Injections including parenteral infusions e.g. nutrition mixtures§  Tablets, capsules, cachets§  Specialised dose forms for medicinal purposes (powders, depot products, inhalation products, transdermal products)§  Extemporaneous preparation·         Properties of excipients and ingredients in pharmaceutical products§  Thickeners, sweeteners, buffers, tonicity adjusters, preservatives, flavours and stabilisers·         Principles of Rheology (viscosity and fluid flow)·         Key chemical and physical reactions involved in the preparation, stabilisation, and degradation of medicinal products§  Solubility, dissolution,§  Ionisation, de-ionisation of water, conductivity§  pH and acid-base reactions§  Precipitation, salting out, flocculation§  Complexation etc.§  Redox reactions, (oxidation, reduction, redox potentials)§  Partitioning, phase separation,§  Thermal issues, boiling point, melting point, volatilisation/vapours§  Thermolabile degradation / effects of temperature etc.·         Criticality of final packaging§  Container types and closures§  Factors relevant to product protection§  Labelling·         Mathematical principles and calculations for pharmaceutical sciences§  Buffering and related calculations§  Dilutions and dose adjustments§  Tonicity adjustments·         Miscellaneous§  Principles of drug absorption and uptake§  Transport across membranes§  Principles of compounding parenteral nutrition mixtures <div> The unit aims to provide students with background knowledge of formulation sciences, aseptic preparation and classical batch manufacture. The unit provides a good proportion of practical study enabling students to appreciate how the theory applies in practice. The aseptic element provides students with an in-depth working knowledge of pharmaceutical microbiological aspects of aseptic manufacture and preparation. Students will also develop an ability to evaluate the use of cleanrooms and clean air devices in order to maintain patient safety.The formulation sciences element will define the principles of pharmaceutical science and formulation. Students will understand the process of designing a new product and building the analytical specifications and stability studies in order to bring a new product to market. Production will prepare students to evaluate and develop services in production of pharmaceuticals. Content includes principles and management of pharmaceutical production, requirements of QA in application to theory and practice of manufacturing and sterilisation of products.</div> Production (10 credits)  <ul> <li> Discuss the role of the technical services professional in ensuring the safety of the patient, particularly related to the manufacture of licensed and unlicensed products and Investigational Medicinal Products including cytotoxic drugs for the treatment of cancer.</li> <li> Apply management principles to the detailed structure of the production process.</li> <li> Describe the principles of Quality Assurance in relation to pharmaceutical production.</li> <li> Show the relevance of pharmaceutical law and regulations.</li> <li> Explain the process of product design.</li> <li> Explain and critically evaluate the theory and practice of pharmaceutical manufacturing, assembly, preparation and dispensing.</li> <li> Apply the principles of processing in regard to pharmaceutical production.</li> <li> Explain the principles of sterilisation by irradiation, filtration, gas, moist and dry heat.</li> </ul> Aseptics (10 credits) <ul> <li> Understand the principles of design of facilities.</li> <li> Explain the principles of aseptic manipulation.</li> <li> Describe the principles of basic pharmaceutical microbiology.</li> <li> Analyse and interpret monitoring data and diagnose problems.</li> <li> Evaluate monitoring equipment and operational records.</li> <li> Explain the key chemical and physical reactions affecting the stability of medicinal products.</li> <li> Resolve drug formulation and administration problems, particularly where they relate to the modification and optimisation.</li> </ul> Formulation Sciences (10 credits) <ul> <li> Describe the principles of pharmaceutical formulation and processing.</li> <li> Describe the properties of excipients and ingredients in pharmaceutical products.</li> <li> Explain the factors affecting formulation, stability and preservation of pharmaceutical product.</li> <li> Perform mathematical calculations relevant to pharmaceutical formulation.</li> <li> Describe the principles of sterilisation.</li> <li> Understand the criticality of final packaging.</li> </ul> <ul> <li> Appraise and interpret information from different sources in order to develop a coherent critical analysis of issues relating to the practice and delivery of clinical pharmaceutical science services.</li> <li> Perform detailed investigations in order to establish the root cause of exceptions using a variety of tools available. To perform detailed risk assessments and to allocate appropriate corrective and preventive actions (CAPA).</li> <li> Critically appraise the impact of the pharmaceutical production process on the quality of the clinical outcomes.</li> <li> Reviewing of technical agreements with suppliers and service providers.</li> <li> Perform analytical method validation and equipment validation.</li> <li> Interpret QC data and investigate questionable results.</li> </ul> <ul> <li> Demonstrate professionalism and ethical awareness.</li> <li> Apply the principles of EU Good Manufacturing Practice (GMP) to develop a safe new product.</li> <li> Perform all manufacturing activities in accordance with requirements for Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems.</li> <li> Work within the principles and practice of instruments, equipment and methodology used in pharmacy technical services.</li> <li> Support safe storage and distribution of medicinal products.</li> <li> Identify validation requirements for any changes to processes.</li> </ul> <ul> <li> Communicate effectively in a variety of settings with a range of individuals.</li> <li> Use logical and systematic approaches to problem-solving and decision-making.</li> <li> Use effective negotiation skills, including influencing colleagues.</li> <li> The ability to plan and devise a framework and timetable for action and carry these out systematically, either for individual purposes or in a group context.</li> </ul> <div> <ul> <li> Unit-specific teaching blocks including workshops and practicals.</li> <li> E-learning: evidence-based learning supported by course notes, audio lectures and discussion boards.</li> </ul> </div>   1 Written exam 100%  Aseptics Portfolio(Critically reviewed observations/evidence documented against all topics required by portfolio specification.) Pass/FailProduction Portfolio Presentation - 15 minutes(Critically reviewed observations/evidence documented against all topics required by portfolio specification.) Pass/Fail Provisional marks and feedback for coursework returned within 15 working days.Exam marks and final marks returned after ratification at exam board.  MSc PTQA (Pharm Tech & QA) MSc PTQA (Pharm Tech & QA) PGDT Taught Component Recommended PGCert PTQA (Pharm Tech & QA) PGCert PTQA (Pharm Tech & QA) PGDT Taught Component Recommended N Assessment written exam 2 Lectures 66 0 232