Production 2 (SPE221)

10 credits

Aim of this module

This module will enable the trainee to consolidate their experience of the production processes, equipment and systems that contribute to the provision of high-quality, safe clinical pharmaceutical services and apply their knowledge in a clinical setting. In addition, it will build on the knowledge already gained around the development of a new pharmaceutical product.

  1. Apply the principles of EU Good Manufacturing Practice to develop a safe new product.
  2. Observe, assist and where appropriate perform, under supervision, a range of processes and procedures in accordance with local practice in order to manufacture products safely.
  3. Perform a range of activities to support safe storage and distribution of medicinal products.
  4. Perform all manufacturing activities in accordance with requirements for EU Good Manufacturing Practice and pharmaceutical management quality systems.
Number Work-based learning outcome Title Knowledge
1 1

Safely formulate a new product or variation on an existing product.

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2 1

Correctly select and identify validation requirements for a suitable container and closure system for a new product.

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3 1

Design labels that comply with the legal requirements and make judicious use of colours to improve differentiation.

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4 1

Correctly identify validation requirements for any changes to processes caused by the introduction of a new product.

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5 1

Plan and assist in training a member of staff to perform a new task and evaluate your teaching, setting out an action plan for your next teaching session.

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6 2

Manufacture of a range of various pharmaceutical dosage forms.

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7 2

Perform planned preventative maintenance (PPM) for a clean room and/or piece of equipment.

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8 2

Take appropriate samples for in- process controls.

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9 2

Perform filter integrity testing.

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10 2

Assist in scheduling of maintenance and calibration of production equipment.

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11 3

Perform temperature mapping.

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12 3

Investigate temperature excursion.

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13 4

Critically appraise previous cleaning validations and consider the implications of the introduction of a new product or on any existing cleaning validations.

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14 4

Interpret an autoclave chart. Critically appraise previous validations, e.g. container/closures, sterilisers.

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15 4

Draft a technical agreement with a supplier.

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16 4

Witness inspection, review and monitoring of quality systems including audit procedures.

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17 4

Review/write an investigation report.

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18 4

Assist in determining corrective actions preventative actions (CAPA) following a quality incident.

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19 4

Assist in reviewing a CAPA after a pre-determined period of time to assess impact of action on a process.

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20 4

Assist in a real or mock recall, working through the steps required to ensure products can be recalled successfully.

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You must complete
3 Case-based discussion(s)
2 of the following DOPS / OCEs
Assessment Title Type
Devise a checklist that would be required for the introduction of a new manufactured product including starting material assessment, area of preparation, clean down validation considerations, stability assessment using appropriate reference sources DOPS
Approve production equipment or components following cleaning or sterilisation. This would involve assessing any relevant documentation and assessing the status of the items prior to approving for use in the manufacture of medicines. DOPS
Demonstrate the process of water purification and storage DOPS
Discuss with colleagues the challenges, practicalities and limitations when considering the introduction of a new manufactured product OCE
Design a label for a new product and ensure that it is in compliance with current regulations and requirements of GMP and Eudralex OCE
Explain to a clinical colleague why a defective manufactured product cannot be released for clinical use OCE

Important information

The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.

Learning Outcomes

  1. Discuss the role of the Clinical Scientist in Production 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.
  2. Apply management principles to the detailed structure of the production process.
  3. Describe the principles of quality assurance in relationto pharmaceutica production.
  4. Show the relevance of pharmaceutical law and regulations.
  5. Explain the process of product design.
  6. Explain and critically evaluate the theory and practice of pharmaceutical manufacturing, assembly, preparation and dispensing.
  7. Apply the principles of processing in regard to pharmaceutical production.
  8. Explain the principles of sterilisation by irradiation, filtration, gas, moist and dry heat.

 

 

Indicative Content

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 o Measuring o Milling
  • Mixing
  • Filling
  • Sealing
  • Filtration – clarification/sterilisation

Sterilisation methods

  • Application of microbiology to sterilisation techniques
  • Health Technical Memorandum 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
  • Health Technical Memorandum 2031 – Clean Steam
  • Health Technical Memorandum 2030 – Washers