Module - Production 1 (SPE202)

STP

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.

Work-based learning outcomes


  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.

Work-based Competencies


Learning outcome Title Knowledge
1 1

Select an appropriate production method for a new product

  • Principles of pharmaceutical formulation and processing.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Factors affecting formulation, stability and preservation of pharmaceutical product.
  • Factors affecting the choice of container/closure systems for different types of products – compatibility with product/processes/method of administration.
  • Advantages and disadvantages of different methods of production, eg terminally sterilised vs aseptic preparation; gassing vs liquid disinfection for isolators.
  • Limitations of sterilising methods, eg heat labile drug/excipient/container, container effected by methods of sterilisation, eg glass going amber on irradiation.
  • Labelling requirements.
  • Tallman lettering.
  • Judicious use of colour.
  • Medicines and Healthcare products Regulatory Agency guidance
  • Requirements of label adhesive (fridge, permanent, peelable, etc).
  • Additional labelling.
  • Limitations of available facilities and equipment.
2 1

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

  • Principles of pharmaceutical formulation and processing
  • Properties of excipients and ingredients in pharmaceutical products
  • Factors affecting formulation, stability and preservation of pharmaceutical product
  • Factors affecting the choice of container/closure systems for different types of products – compatibility with product/processes/method of administration
  • Advantages and disadvantages of different methods of production, eg terminally sterilised vs aseptic preparation; gassing vs liquid disinfection for isolators
  • Limitations of sterilising methods, eg heat labile drug/excipient/container, container effected by methods of sterilisation, eg glass going amber on irradiation
  • Labelling requirements
  • Tallman lettering
  • Judicious use of colour
  • Medicines and Healthcare products Regulatory Agency guidance
  • Requirements of label adhesive (fridge, permanent, peelable, etc)
  • Additional labelling
  • Limitations of available facilities and equipment
3 1

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

  • Principles of pharmaceutical formulation and processing.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Factors affecting formulation, stability and preservation of pharmaceutical product
  • Factors affecting the choice of container/closure systems for different types of products – compatibility with product/processes/method of administration.
  • Advantages and disadvantages of different methods of production, eg terminally sterilised vs aseptic preparation; gassing vs liquid disinfection for isolators.
  • Limitations of sterilising methods, eg heat labile drug/excipient/container, container effected by methods of sterilisation, eg glass going amber on irradiation.
  • Labelling requirements.
  • Tallman lettering.
  • Judicious use of colour.
  • Medicines and Healthcare products Regulatory Agency guidance.
  • Requirements of label adhesive (fridge, permanent, peelable, etc).
  • Additional labelling.
  • Limitations of available facilities and equipment.
5 1

Select appropriate container/closure system for new product

  • Principles of pharmaceutical formulation and processing.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Factors affecting formulation, stability and preservation of pharmaceutical product.
  • Factors affecting the choice of container/closure systems for different types of products – compatibility with product/processes/method of administration.
  • Advantages and disadvantages of different methods of production, eg terminally sterilised vs aseptic preparation; gassing vs liquid disinfection for isolators.
  • Limitations of sterilising methods, eg heat labile drug/excipient/container, container effected by methods of sterilisation, eg glass going amber on irradiation.
  • Labelling requirements.
  • Tallman lettering.
  • Judicious use of colour.
  • Medicines and Healthcare products Regulatory Agency guidance.
  • Requirements of label adhesive (fridge, permanent, peelable, etc).
  • Additional labelling.
  • Limitations of available facilities and equipment.
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

  • Properties of different types of pharmaceutical products that are manufactured
  • Awareness of processe.s used in the manufacture of the different types of products.
  • Awareness of different equipment used.
  • The theory underpinning the manufacturing processes.
  • Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting
  • Different methods of sampling.
  • Clean in Place (CIP) and Sterilise in Place (SIP).
  • Types of cleaning products.
  • Rinsing, drying.
  • Storage of raw materials and products.
  • Time limits for leaving ‘clean’.
  • British Pharmacopoeia requirements for different types of products and consequences of non-compliant products.
  • Different equipment used to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
  • Importance of daily safety checks, general health and safety requirements, and permit to work systems.
  • Awareness of maintenance and calibration requirements.
  • Importance of reporting deviations.
  • Current in-house training programmes
  • The importance of avoiding cross-contamination.
  • Bioburden limitation.
  • Sterility assurance level.
7 2

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

  • Properties of different types of pharmaceutical products that are manufactured.
  • Awareness of processes used in the manufacture of the different types of products.
  • Awareness of different equipment used.
  • The theory underpinning the manufacturing processes.
  • Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting.
  • Different methods of sampling.
  • Clean in Place (CIP) and Sterilise in Place (SIP).
  • Types of cleaning products.
  • Rinsing, drying.
  • Storage of raw materials and products.
  • Time limits for leaving ‘clean’
  • British Pharmacopoeia requirements for different types of products and consequences of non-compliant products
  • Different equipment u.sed to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
  • Importance of daily safety checks, general health and safety requirements, and permit to work systems.
  • Awareness of maintenance and calibration requirements.
  • Importance of reporting deviations.
  • Current in-house training programmes.
  • The importance of avoiding cross-contamination.
  • Bioburden limitation.
  • Sterility assurance level.
8 2

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

  • Properties of different types of pharmaceutical products that are manufactured.
  • Awareness of processes used in the manufacture of the different types of products.
  • Awareness of different equipment used.
  • The theory underpinning the manufacturing processes.
  • Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting.
  • Different methods of sampling.
  • Clean in Place (CIP) and Sterilise in Place (SIP).
  • Types of cleaning products.
  • Rinsing, drying.
  • Storage of raw materials and products.
  • Time limits for leaving ‘clean’.
  • British Pharmacopoeia requirements for different types of products and consequences of non-compliant products.
  • Different equipment used to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
  • Importance of daily safety checks, general health and safety requirements, and permit to work systems.
  • Awareness of maintenance and calibration requirements.
  • Importance of reporting deviations.
  • Current in-house training programmes.
  • The importance of avoiding cross-contamination.
  • Bioburden limitation.
  • Sterility assurance level.
9 2

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

  • Properties of different types of pharmaceutical products that are manufactured.
  • Awareness of processes used in the manufacture of the different types of products.
  • Awareness of different equipment used.
  • The theory underpinning the manufacturing processes.
  • Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting.
  • Different methods of sampling.
  • Clean in Place (CIP) and Sterilise in Place (SIP).
  • Types of cleaning products.
  • Rinsing, drying.
  • Storage of raw materials and products.
  • Time limits for leaving ‘clean’
  • British Pharmacopoeia requirements for different types of products and consequences of non-compliant products.
  • Different equipment used to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
  • Importance of daily safety checks, general health and safety requirements, and permit to work systems.
  • Awareness of maintenance and calibration requirements.
  • Importance of reporting deviations.
  • Current in-house training programmes.
  • The importance of avoiding cross-contamination.
  • Bioburden limitation.
  • Sterility assurance level.
10 2

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

  • Properties of different types of pharmaceutical products that are manufactured.
  • Awareness of processes used in the manufacture of the different types of products.
  • Awareness of different equipment used.
  • The theory underpinning the manufacturing processes.
  • Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting.
  • Different methods of sampling.
  • Clean in Place (CIP) and Sterilise in Place (SIP).
  • Types of cleaning products.
  • Rinsing, drying.
  • Storage of raw materials and products.
  • Time limits for leaving ‘clean’.
  • British Pharmacopoeia requirements for different types of products and consequences of non-compliant products.
  • Different equipment used to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
  • Importance of daily safety checks, general health and safety requirements, and permit to work systems.
  • Awareness of maintenance and calibration requirements.
  • Importance of reporting deviations.
  • Current in-house training programmes.
  • The importance of avoiding cross-contamination.
  • Bioburden limitation.
  • Sterility assurance level.
11 2

Perform the visual inspection of products

  • Properties of different types of pharmaceutical products that are manufactured.
  • Awareness of processes used in the manufacture of the different types of products.
  • Awareness of different equipment used.
  • The theory underpinning the manufacturing processes.
  • Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting.
  • Different methods of sampling.
  • Clean in Place (CIP) and Sterilise in Place (SIP).
  • Types of cleaning products.
  • Rinsing, drying.
  • Storage of raw materials and products.
  • Time limits for leaving ‘clean’.
  • British Pharmacopoeia requirements for different types of products and consequences of non-compliant products.
  • Different equipment used to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
  • Importance of daily safety checks, general health and safety requirements, and permit to work systems.
  • Awareness of maintenance and calibration requirements.
  • Importance of reporting deviations.
  • Current in-house training programmes.
  • The importance of avoiding cross-contamination.
  • Bioburden limitation.
  • Sterility assurance level.
12 2

Collect water appropriately for use in pharmaceutical manufacturing

  • Properties of different types of pharmaceutical products that are manufactured.
  • Awareness of processes used in the manufacture of the different types of products
  • Awareness of different equipment used.
  • The theory underpinning the manufacturing processes.
  • Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting.
  • Different methods of sampling.
  • Clean in Place (CIP) and Sterilise in Place (SIP).
  • Types of cleaning products.
  • Rinsing, drying.
  • Storage of raw materials and products.
  • Time limits for leaving ‘clean’.
  • British Pharmacopoeia requirements for different types of products and consequences of non-compliant products.
  • Different equipment used to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
  • Importance of daily safety checks, general health and safety requirements, and permit to work systems.
  • Awareness of maintenance and calibration requirements.
  • Importance of reporting deviations.
  • Current in-house training programmes.
  • The importance of avoiding cross-contamination.
  • Bioburden limitation.
  • Sterility assurance level.
13 2

Assist in the cleaning of equipment and facilities

  • Properties of different types of pharmaceutical products that are manufactured.
  • Awareness of processes used in the manufacture of the different types of products.
  • Awareness of different equipment used.
  • The theory underpinning the manufacturing processes.
  • Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting.
  • Different methods of sampling.
  • Clean in Place (CIP) and Sterilise in Place (SIP).
  • Types of cleaning products.
  • Rinsing, drying.
  • Storage of raw materials and products.
  • Time limits for leaving ‘clean’.
  • British Pharmacopoeia requirements for different types of products and consequences of non-compliant products.
  • Different equipment used to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
  • Importance of daily safety checks, general health and safety requirements, and permit to work systems.
  • Awareness of maintenance and calibration requirements
  • Importance of reporting deviations.
  • Current in-house training programmes.
  • The importance of avoiding cross-contamination.
  • Bioburden limitation.
  • Sterility assurance level.
14 2

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

  • Different types of equipment used to prepare, containers/closures/components.
15 2

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

  • Standard procedures for cleaning sterilisation equipment.
  • Standard procedures for monitoring and review of documentation.
16 2

Observe and assist in performing planned preventative maintenance (PPM)

  • Purpose of planned preventative maintenance.
  • Process of planned preventative maintenance.
17 2

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

  • Procedure for returning equipment into use.
18 3

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

  • Importance of stock rotation of raw materials and finished products and ability to describe methods of achieving correct stock rotation.
  • Returns procedure and understand the implications of checks that need to occur before products are received back into stock.
  • Recall procedure.
  • Cold chain requirements.
  • Stock check procedures.
19 3

Observe the management of raw material and finished product inventories

  • Importance of stock rotation of raw materials and finished products and ability to describe methods of achieving correct stock rotation.
  • Returns procedure and understand the implications of checks that need to occur before products are received back into stock.
  • Recall procedure.
  • Cold chain requirements.
  • Stock check procedures.
20 3

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

  • Importance of stock rotation of raw materials and finished products and ability to describe methods of achieving correct stock rotation.
  • Returns procedure and understand the implications of checks that need to occur before products are received back into stock.
  • Recall procedure.
  • Cold chain requirements.
  • Stock check procedures.
21 3

Deal with receipt or dispatch of cold chain items

  • Importance of stock rotation of raw materials and finished products and ability to describe methods of achieving correct stock rotation.
  • Returns procedure and understand the implications of checks that need to occur before products are received back into stock.
  • Recall procedure.
  • Cold chain requirements.
  • Stock check procedures.
22 4

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

  • Range of in-process controls.
  • The purpose and importance of in-process controls and testing.
  • The purpose and requirements of quarantine and release procedures.
  • EU Good Manufacturing Practice.
  • Appreciate the need for in-house calibration.
  • Importance of scheduling maintenance and calibrations, eg sterilisers, balances.
  • Requirements of all Water for Injections (WFI) production and storage systems.
  • Requirements of different grades of pharmaceutical water.
  • Systems for:
    • corrective actions and preventative actions (CAPA)
    • investigation reports
    • issuing of standard operating procedures (SOPs) and batch manufacturing records (BMRs)
    • change control
    • customer complaints
    • deviations
    • audit.
23 4

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

  • Water for Injections (WFI) production and storage systems.
  • Process validation.
24 4

Assist/write investigation report for discussion and dissemination

• Report writing.

4 1

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

  • Principles of pharmaceutical formulation and processing.
  • Properties of excipients and ingredients in pharmaceutical products.
  • Factors affecting formulation, stability and preservation of pharmaceutical product.
  • Factors affecting the choice of container/closure systems for different types of products – compatibility with product/processes/method of administration.
  • Advantages and disadvantages of different methods of production, eg terminally sterilised vs aseptic preparation; gassing vs liquid disinfection for isolators.
  • Limitations of sterilising methods, eg heat labile drug/excipient/container, container effected by methods of sterilisation, eg glass going amber on irradiation.
  • Labelling requirements.
  • Tallman lettering.
  • Judicious use of colour.
  • Medicines and Healthcare products Regulatory Agency guidance.
  • Requirements of label adhesive (fridge, permanent, peelable, etc).
  • Additional labelling.
  • Limitations of available facilities and equipment.

Work-based assessment


Complete 1 Case-Based Discussion(s)
Complete 1 of the following DOPS and/or OCEs
Type Title
DOPS 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
OCE Explain the clinical uses of a range products
OCE Explain to a clinical colleague why a defective product cannot be released for clinical use