Production 1 (SPE202)

10 credits

Aim of this module

This rotation introduces trainees to manufacturing and production procedures and will enable them to gain skills and experience in manufacturing and production, from the development of a safe new product through the manufacturing process to storage and distribution. Trainees will gain experience through observation, assisting with or performing a range of routine procedures in the context of providing high-quality safe medicines used in the treatment of a range of patients and will be expected to develop and build their professional practice.

  1. Apply the principles of EU Good Manufacturing Practice to develop a safe new product and assess the scope of the licence held by the organisation when considering a 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 (This includes the clothing requirements and handling of waste. The range of equipment used may include autoclaves, dry heat sterilising ovens, filling machines, filter integrity testers, mixers, capping machines, equipment used for the preparation of containers and balances).
  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 Good Manufacturing Practice and pharmaceutical management quality systems.
Number Work-based learning outcome Title Knowledge
1 1

Select an appropriate production method for a new product

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2 1

Design a label in accordance with the requirements for labelling medicinal products

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3 1

Identify all equipment that would be required to manufacture a particular product

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5 1

Select appropriate container/closure system for new product

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6 2

Assist in the manufacture of a variety of products, including solutions, creams (emulsions), ointments, suppositories, tablets, capsules and suspensions, dependent on the facilities and range of products available on site

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7 2

Manipulate a range of active pharmaceutical ingredients in a range of dosage forms, including the use of common excipients

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8 2

Assist in the operation of a range of various pieces of pharmaceutical manufacturing equipment

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9 2

Assist in the receipt, storage and issue of raw materials, packaging components and labels

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10 2

Generate labels correctly, carry out line clearances and correctly label products

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11 2

Perform the visual inspection of products

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12 2

Collect water appropriately for use in pharmaceutical manufacturing

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13 2

Assist in the cleaning of equipment and facilities

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14 2

Assist in the preparation of a variety of components/containers/closures prior to use in manufacture

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15 2

Assist in the cleaning, monitoring and review of documentation with respect to sterilising equipment

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16 2

Observe and assist in performing planned preventative maintenance (PPM)

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17 2

Observe the process for determining any actions to be taken before returning equipment to use following servicing and assist in this process

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18 3

Assist in product distribution and sales, monitoring of the disposal of out-of-date stock

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19 3

Observe the management of raw material and finished product inventories

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20 3

Undertake a stock check on starting materials and finished products and work through the process for returning a product into stock

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21 3

Deal with receipt or dispatch of cold chain items

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22 4

Place a batch in quarantine Observe the checks required on systems, pharmaceutical water and environment prior to product release

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23 4

Assist in process validation, monitoring and testing in accordance with procedure

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24 4

Assist/write investigation report for discussion and dissemination

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4 1

Assist in writing/reviewing the standard operating procedure/batch manufacturing record

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You must complete
1 Case-based discussion(s)
1 of the following DOPS / OCEs
Assessment Title Type
Assemble materials in accordance with a batch manufacturing procedure DOPS
Demonstrate correct usage of an item of equipment from this list autoclaves dry heat sterilising ovens, filling machines, filter integrity testers mixers capping machines equipment used for the preparation of containers and balances DOPS
Demonstrate use of in process controls DOPS
Monitor sterilisation logs DOPS
Validate and use a cleaning procedures DOPS
Observe the inspection storage and quarantine of products DOPS
Demonstrate the process of water purification and storag DOPS
Explain the clinical uses of a range products OCE
Explain to a clinical colleague why a defective 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 Clinical Pharmaceutical Sciences in ensuring the safety of the patient, particularly related to the manufacture and quality control with reference to key patient care pathways. 
  2. Describe the principles of pharmaceutical formulation and processing
  3. Describe the properties of excipients and ingredients in pharmaceutical products
  4. Explain the factors affecting formulation, stability and preservation of pharmaceutical product
  5. Perform mathematical calculations relevant to pharmaceutical formulation
  6. Describe the principles of sterilisation
  7. Understand the criticality of final packaging

Indicative Content

Clinical Pharmaceutical Science in key patient and care pathways

  • Diagnosis using radioactive materials
  • Treatment relevant to the patient and care pathway, including chemotherapy
  • Treatment using radioactive materials
  • The role of regulation, Good Manufacturing Practice, aseptic techniques and quality assurance in ensuring patient safety

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
  • Semi-solids, 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, deionisation of water, conductivity
  • pH and acid-base reactions
  • Precipitation, salting out, flocculation
  • Complexation,
  • Redox reactions (oxidation, reduction, redox potentials)
  • Partitioning, phase separation
  • Thermal issues, boiling point, melting point, volatilisation/vapours
  • Thermolabile degradation/effects of temperature,

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