Production —
Training activity: 4

Details

Perform the manufacture of at least two products of differing dosage form, including one non-sterile product

Type

Entrustable training activity (ETA)

Evidence requirements

Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion. ​

Reflection at multiple timepoints on the trainee learning journey for this activity.

Considerations

• Critical controls and the potential impact of any failures on patient safety
• Selection of starting materials
• Preparation of containers and closures
• Weighing
• Mixing
• Heating
• Filling
• Sealing
• Inspection
• Sampling (including in-process)

Reflective practice guidance

The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.

Before action

• Identify what is expected of you in relation to this specific activity by reviewing the specific learning outcomes related to this activity, particularly those concerning performing manufacturing activities according to GMP and PQS and applying quality risk management.
  • Discuss with your Training Officer to gain clarity on what is expected, including specific requirements for the dosage forms, non-sterile product considerations, and any associated documentation or quality checks.
• What is your prior experience of manufacturing products of differing dosage forms?
  • Think about what you already know about manufacturing processes, equipment, and required documentation, considering your prior experience with sterile or non-sterile products.
  • Consider possible challenges you might face during manufacture, such as maintaining aseptic technique (if sterile), ensuring correct formulation, operating specialist equipment, managing deviations, or adhering to GMP requirements. Think about how you might handle these potential issues.
  • Recognise the scope of your own practice for this manufacturing activity. For example, when would you need to seek advice or help regarding equipment calibration, complex formulation issues, or significant process deviations, and from whom would you seek it?
• What do you anticipate you will learn from this manufacturing experience?
  • Consider the specific skills you want to develop, drawing upon previous manufacturing experiences (e.g., improving efficiency, handling specific equipment, troubleshooting minor issues, or refining your documentation accuracy).
  • Identify the specific insights you hope to gain, such as a deeper understanding of critical control points and critical quality attributes for different dosage forms, or the practical application of quality risk management principles during production.
• What additional considerations do you need to make before performing the manufacture?
  • Consult actions identified following previous experiences of manufacturing activities. Have you identified any areas for improvement in your technique, documentation, or problem-solving that you need to focus on during this session?
  • Identify important information you need to consider before embarking on the activity, such as reviewing the specific manufacturing batch record, ensuring all raw materials are approved and available, checking equipment calibration, and understanding the quality control sampling plan.

In action

• During the manufacturing activity, is anything unexpected occurring?
  • Make a note of anything that feels surprising or different from what you anticipate during the manufacture of the products. This can include:
    • An unexpected equipment malfunction or alarm.
    • A raw material behaving differently than expected (e.g., not dissolving, unusual consistency).
    • A process parameter (temperature, pressure, mixing speed) deviating from the batch record.
    • An unexpected appearance of the product at an intermediate stage.
    • A deviation from the standard operating procedure (SOP) that requires immediate attention.
  • Consider how this experience compares with previous experiences of similar manufacturing activities. Is this a completely new type of challenge, or does it remind you of something you have encountered before?
• How are you reacting to the unexpected development during the manufacture?
  • Identify how this impacts upon your actions. For example:
    • Do you respond to the situation appropriately? Do you immediately pause the process, consult the batch record or SOP, or seek advice?
    • Do you adapt or change your approach to the manufacturing steps based on the unexpected event? How quickly are you able to adjust?
    • Does it affect your ability to undertake the activity independently or do you need to immediately seek support from your Training Officer or another colleague?
• Consider how you feel in that moment. For example:
  • Do you find it difficult to adapt to the unexpected situation?
  • Does it affect your confidence in your ability to complete the manufacture?
  • Do you feel positive you can reach a successful conclusion despite the unexpected event?
• What is the immediate conclusion or outcome of your reaction to the unexpected development?
  • Identify how you work within your scope of practice to address the unexpected event. Do you recognise when you need to escalate or document a deviation?
  • Identify what you learn as a result of the unexpected development while it is unfolding. This can be a new troubleshooting technique, the importance of a specific procedural step, or a deeper understanding of equipment limitations.

On action

• What happened during the manufacturing activity?
  • Summarise the key points of the manufacturing experience, from preparation to completion.
  • Consider specific events, actions, or interactions that felt important, including your own feelings during the manufacturing process.
  • Include any ‘reflect-in-action’ moments where you adapted to unexpected situations or made immediate decisions while the manufacture was unfolding. For example, if you paused due to an equipment anomaly, how did you respond and what was the immediate outcome at that moment?
• How has this manufacturing experience contributed to your developing practice?
  • Identify what learning you can take from this manufacturing experience. What strengths did you demonstrate, particularly in adhering to GMP/PQS, handling equipment, or managing quality risks? Were any skills or knowledge gaps evident related to formulation, processing, or equipment calibration?
  • Compare this experience against previous engagements with similar manufacturing activities. Were any previously identified actions for development achieved? Has your practice improved in areas such as precision, efficiency, or problem-solving during manufacture?
  • Identify any challenges you experienced during the manufacture and how you reacted to these. Did this affect your ability to deal with the situation independently? Were you able to overcome the challenges, such as unexpected material behaviour or deviations from procedures?
  • Identify anything significant about the activity. Did you need to seek advice or clarification from your Training Officer or colleagues, for instance, regarding a deviation or a complex step? Did you need to escalate any issue to ensure you were working within your scope of practice?
  • Acknowledge any changes in your own feelings now that you are looking back on the experience. Do you feel more confident or competent in performing manufacturing activities?
• What will you take from this manufacturing experience moving forward?
  • Identify the actions or ‘next steps’ you will now take to support the assimilation of what you have learnt, including from any feedback you received.
  • What will you do differently next time you perform manufacturing activities, especially if faced with similar challenges or unexpected events?
  • Has anything changed in terms of what you would do if you were faced with a similar manufacturing situation again?
  • Do you need to practise any aspect of the activity further, such as specific equipment operation, aseptic techniques (if applicable), or documentation practices?

Beyond action

• Have you revisited your previous manufacturing experiences?
  • Have you reviewed your actions from your previous reflections for performing manufacturing activities?
  • What actions did you identify you would need to take to improve your manufacturing practice (e.g., related to GMP adherence, equipment handling, quality risk management, or specific techniques for different dosage forms)
  • Have you completed these identified actions from previous manufacturing experiences?
  • Are you ready to demonstrate this new learning in your current and future manufacturing practice?
  • Consider if your view of manufacturing situations (e.g., unexpected deviations, complex equipment operation, or adherence to PQS) has changed because of analysing this with others.
• How have these collective manufacturing experiences impacted your current practice?
  • Consider how the learning from repeated manufacturing activities will support you in preparing for observed ‘in-person’ assessments for the module.
  • Consider how your practice in performing manufacturing activities has developed and evolved over time, including recognising when something related to pharmaceutical production or equipment use is beyond your scope of practice and requires seeking advice or escalation.

Relevant learning outcomes

#	Outcome
# 1	Outcome Describe the working practices of pharmaceutical production.
# 3	Outcome Perform a range of manufacturing activities, using specialist equipment, in accordance with requirements for GMP and pharmaceutical quality management systems.
# 5	Outcome Perform activities to support safe storage and distribution of medicinal products applying the principles of Good Distribution Practice (GDP).
# 6	Outcome Apply the principles of quality risk management to the manufacturing process.