Production —
Training activity: 4

Details

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

Type

Developmental training activity (DTA)

Evidence requirements

Evidence the activity has been undertaken by the trainee​.

Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.

An action plan to implement learning and/or to address skills or knowledge gaps identified.

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

What are the intended outcomes of the training activity?

• How will reviewing the specified learning outcomes help you focus on the requirement to perform manufacturing activities in accordance with Good Manufacturing Practice (GMP) and pharmaceutical quality management systems?
• In what ways will this activity develop your ability to describe the working practices of pharmaceutical production and the role of the clinical pharmaceutical scientist in ensuring patient safety?
• What steps will you take to apply the principles of quality risk management (QRM) to the manufacturing process to ensure you can define critical control points (CCPs) and critical quality attributes (CQAs) for these specific dosage forms?
• How will you ensure you can clearly support the safe storage and distribution of these medicinal products by applying the principles of Good Distribution Practice?

What do you anticipate you will learn from the experience?

• What specific insights do you hope to gain regarding the formulation, production methods, and specialist equipment requirements unique to each of the two differing dosage forms, particularly the non-sterile product?
• How do you anticipate this experience will improve your ability to correlate theoretical principles of formulation—such as solubility, pH, and rheology—with real-time production outcomes?
• What do you expect to learn about the practical differences in environmental controls and contamination risks when manufacturing a non-sterile product compared to your second chosen dosage form?
• In what ways do you anticipate this experience will prepare you for the high-level interpretive and analytical responsibilities required for post-programme professional practice?

What actions will you take in preparation for the experience?

• How will you discuss the scope of this manufacturing task with your Training Officer to ensure you understand the departmental protocols and the expected standards for both dosage forms?
• Which theoretical principles of pharmaceutical formulation, stability, and preservation will you review beforehand to ensure your manufacturing accuracy?
• How will you use the department’s Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs) to familiarise yourself with the raw material approval, equipment calibration, and process validation requirements before you begin?
• How will you prepare for potential challenges, such as managing deviations, handling complex active pharmaceutical ingredients (APIs), or resolving equipment failures during the production run?
• How do you feel about embarking on this manufacturing activity, and what areas have you identified for focused preparation to increase your technical confidence?

In action

What are you doing?

• As you perform the manufacture of the non-sterile product and your second dosage form, how are you approaching the setup and operation of specialist equipment?
• Why are you following the specific steps in the Manufacturing Batch Record (MBR) in a particular order to maintain compliance with Good Manufacturing Practice (GMP)?
• What decisions are you making as the production progresses, particularly regarding in-process checks or the monitoring of critical control points?
• Which parts of the manufacturing process (e.g., basic weighing, labelling) feel intuitive, and which parts—such as managing complex formulations or specialist equipment calibration—require more conscious effort?

How are you progressing with the activity?

• How effective are your actions in ensuring the products meet their critical quality attributes as the manufacture unfolds?
• What technical or environmental challenges are you facing during the production of these two differing dosage forms, and how are you managing them in the moment?
• How does this practical manufacture connect to your theoretical understanding of pharmaceutical formulation (e.g., solubility, pH, or rheology) and the broader working practices of pharmaceutical production?
• How are you actively applying the principles of Quality Risk Management (QRM) to mitigate potential contamination or errors while you work?

How are you adapting to the situation?

• If a process parameter deviates (such as temperature or mixing speed), what alternative approaches or adjustments are you considering to remain within the validated process limits?
• At what point during the manufacture do you feel the need to pause and seek guidance from your Training Officer to ensure you remain within your scope of practice?
• How are you adapting your actions to ensure the finished products are handled according to Good Distribution Practice (GDP) for safe storage and subsequent distribution?
• Are you adjusting your movements or techniques to maintain the required environmental standards for the specific dosage forms being produced?

On action

What did you notice?

• What were the key points and stages of the manufacturing experience, from the initial preparation of the non-sterile product through to the completion of the second dosage form?
• What specific technical or environmental differences did you notice between the production of these two differing dosage forms?
• In what ways did you observe Good Manufacturing Practice (GMP) and pharmaceutical quality management systems (PQS) being practically integrated into the daily working practices of the production unit?
• What interactions or events during the manufacture felt particularly significant, such as the calibration of specialist equipment or the handling of specific excipients?
• How were the principles of Good Distribution Practice (GDP) visibly applied as you moved the finished products into safe storage?

What did you learn from the activity?

• What new skills or knowledge did you develop regarding the pharmaceutical formulation, stability, and preservation of the specific products you manufactured?
• How did this experience improve your ability to identify and monitor critical control points (CCPs) and critical quality attributes (CQAs) within a live manufacturing process?
• In what ways did your reflection-in-action (decisions made in the moment) influence the successful outcome of the manufacture, particularly when managing equipment anomalies or process deviations?
• What did you learn about applying Quality Risk Management (QRM) to the production process to ensure patient safety and product integrity?
• How does this manufacturing experience relate to the high-level interpretive and analytical responsibilities you will hold in your post-programme professional practice?

What will you take from the experience moving forward?

• What specific actions or ‘next steps’ will you now take to support the assimilation of the technical knowledge you have gained about these dosage forms?
• How will you apply the principles of Good Manufacturing Practice and quality risk assessment more effectively in your routine practice as a result of this activity?
• What areas for continued development have been identified—for example, do you need further practice with specific specialist equipment, mathematical calculations for formulations, or documentation practices?
• What support or resources (such as senior peer review, further SOP study, or specialist training) might you need to further develop your competence in pharmaceutical production?
• How has this experience changed your perspective on the role of the Clinical Pharmaceutical Scientist in ensuring the safety and availability of medicinal products?

Beyond action

Have you revisited the experiences?

• Consider how your understanding of the critical control points (CCPs) and critical quality attributes (CQAs) for the non-sterile product and your second dosage form has evolved since you first performed the manufacture.
• How does your performance in this training activity compare with your Observed Training Activities (OTAs), what observable behaviours—such as strict adherence to GMP or refined specialist equipment handling—have you successfully assimilated into your routine practice?
• Have you engaged in professional storytelling with peers or Training Officers regarding the challenges of manufacturing differing dosage forms? Has this exchange of experiences changed your view on handling unexpected deviations or managing complex formulations?

How have these experiences impacted upon your current practice?

• Rather than seeing these manufactures as isolated incidents, how have they contributed to your overall ability in pharmaceutical quality assurance and patient safety?
• How have you applied your knowledge of Good Manufacturing Practice (GMP) and Quality Risk Management (QRM) since the original experience? For example, has your experience with these specific dosage forms informed how you now approach Material Release audits or Product Quality Reviews?
• How has the learning from these repeated manufacturing activities supported your preparation for ‘in-person’ assessments, such as Case-Based Discussions (CBDs) where you might be required to discuss formulation, stability, or problem investigation?
• How has this experience improved your ability to recognise when a production issue or equipment failure is beyond your scope of practice, requiring escalation to a senior colleague?

How might these experiences contribute towards your future practice?

• What transferable skills did you develop through this activity—such as analytical thinking, attention to detail, and systematic problem-solving—that will be valuable in your future role as a Clinical Pharmaceutical Scientist?
• How will your practical understanding of Good Distribution Practice (GDP) and the safe storage of medicinal products influence your future responsibilities in ensuring the integrity of the pharmaceutical supply chain?
• What clear actions have you identified for the continued development of your technical skills? For example, does your experience suggest a need for further training in advanced statistical analysis for quality trends or a deeper study of regulatory requirements for product release?
• How has mastering the manufacture of differing dosage forms shaped your perspective on the Clinical Scientist’s role in ensuring both product availability and patient safety?

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.