Training activity information
Details
Perform testing of the following types of pharmaceutical products to include HPLC or GC analysis:
- Sterile
- Non-sterile
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
- Test specification
- Pharmacopoeial requirements
- Equipment calibration
- Requirements for new equipment
- Staff competence
- IQC and EQA
- SOPs
- COSHH and PPE
- Documentation
- Data integrity
- Report and/or CofA generation
- Dealing with questionable laboratory results
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 does success look like for performing HPLC or GC analysis on pharmaceutical products?
- Identify what is expected of you in relation to this specific activity. For instance, consider that success involves performing a range of chemical analytical techniques that provide evidence of product quality, ensuring samples meet agreed specifications, and accurately analysing, interpreting, reporting, and acting on the results.
- Consider how demonstrating expertise in chemical analytical techniques like HPLC or GC contributes to ensuring product quality and patient safety, which is a key aim of the Quality Control module.
- Discuss with your training officer to gain clarity on specific expectations for sterile and non-sterile products, and any nuances of HPLC or GC for these types of samples.
- What is your prior experience with performing HPLC or GC analysis on pharmaceutical products (sterile or non-sterile)?
- Think about what you already know about these analytical techniques, including any practical experience with instrument operation, sample preparation, or data analysis.
- Consider possible challenges you might face during the activity, such as instrument troubleshooting, achieving required sensitivity, or interpreting complex chromatograms. Think about how you might handle these potential issues.
- Recognise the scope of your own practice for this activity, specifically knowing when you will need to seek advice or help regarding instrument malfunctions, out-of-specification results, or complex data interpretation, and from whom (e.g., senior analyst, supervisor).
- Acknowledge how you feel about embarking on this training activity. Are you confident in your theoretical understanding of HPLC/GC? Are there any aspects that cause apprehension?
- What do you anticipate you will learn from performing this activity?
- Consider the specific skills you want to develop, drawing upon previous experiences of similar analytical techniques. For example, do you want to improve your practical proficiency with HPLC or GC, enhance your ability to troubleshoot, or deepen your understanding of method validation for different product types?
- Identify the specific insights you hope to gain from engaging with the activity, such as a better understanding of how these analytical techniques contribute to the overall quality control process and patient safety.
- What additional considerations do you need to make before undertaking this activity?
- Consult actions identified following previous experiences of chemical analytical techniques. Did you identify any areas for improvement in your previous reflections that are relevant here?
- Identify important information you need to consider before embarking on the activity, such as reviewing relevant Standard Operating Procedures (SOPs) for the specific products or instruments, understanding the required specifications for sterile and non-sterile products, and reviewing data integrity principles.
In action
- During the activity, does anything unexpected occur?
- Make a note of anything that feels surprising or different from what you anticipate while performing the HPLC or GC analysis, such as an unexpected peak, an instrument error, or an unusual sample characteristic.
- Consider how this experience compares with previous experiences of similar analytical activities. Do you encounter something entirely new, or a known issue manifesting differently?
- How do you react to the unexpected development?
- Identify how the unexpected development impacts upon your actions. For example, do you immediately consult an SOP, try a troubleshooting step, or pause the analysis? Do you respond to the situation appropriately, and are you able to adapt or change your approach effectively?
- Consider how you feel in that moment. Do you find it difficult to adapt to the unexpected? Does it affect your confidence in performing the analysis independently? Do you feel positive you can reach a successful conclusion?
- What is the conclusion or outcome?
- Identify how you work within your scope of practice when encountering the unexpected. Do you know when to proceed, or when to seek advice or help from your Training Officer or another subject matter expert?
- Identify what you learn as a result of the unexpected development. For instance, do you gain new troubleshooting skills or a deeper understanding of instrument limitations?
On action
- What happened during the HPLC or GC analysis?
- Summarise the key steps and results of the HPLC or GC analysis you performed, for both sterile and non-sterile products.
- Detail any unexpected occurrences during the testing, such as unusual chromatograms, instrument errors, or out-of-specification results. How did these feel surprising or different from what you anticipated?
- Describe your actions and reactions to these unexpected developments. Did you consult an SOP, troubleshoot, or seek advice?
- How has this experience contributed to your developing practice in chemical analysis?
- What specific learning can you take from performing this HPLC or GC analysis? What strengths did you demonstrate in executing the analytical techniques or interpreting results?
- Were there any skills or knowledge gaps evident, particularly regarding HPLC/GC operation, troubleshooting, or understanding the implications of your results for product quality?
- How did this experience compare to previous HPLC or GC analyses you have performed? Did your practice improve, particularly in areas like efficiency, accuracy, or problem-solving?
- How did you work within your scope of practice when encountering unexpected results or issues with the analysis? Did you know when to proceed or when to seek advice from your Training Officer or another subject matter expert?
- Reflect on your feelings during and after the analysis. Did difficulties adapting to unexpected issues affect your confidence in performing the analysis independently?
- What will you take from this HPLC or GC analysis experience moving forward?
- What specific actions or next steps will you take to improve your performance in HPLC or GC analysis of pharmaceutical products? This could include further practice, reviewing specific aspects of the method, or deepening your understanding of instrument mechanics.
- Has anything changed in terms of what you would do if faced with similar analytical challenges in the future?
- How will this experience inform your approach to ensuring samples meet agreed specifications through chemical analytical techniques?
Beyond action
- Have you revisited your experiences with HPLC or GC analysis?
- Have you reviewed your previous reflections (before, in, and on-action) for performing HPLC or GC analysis on both sterile and non-sterile pharmaceutical products?
- What specific actions did you identify to enhance your proficiency in executing these chemical analytical techniques, interpreting the results, or troubleshooting instrument issues?
- Have you now successfully implemented these actions, and are you ready to demonstrate improved accuracy or efficiency in your analyses?
- Have you engaged in professional storytelling with peers or senior colleagues regarding complex HPLC/GC troubleshooting scenarios, interpreting unusual chromatograms, or dealing with out-of-specification results for sterile/non-sterile products?
- Has discussing these experiences provided new insights or refined your approach to best practices in chemical analysis and ensuring data integrity?
- How have these cumulative HPLC/GC experiences impacted your current practice?
- How will the cumulative learning from repeated HPLC/GC analyses, and your reflections on them, support your preparation for observed ‘in-person’ assessments?
- How has your practice in performing chemical analytical techniques, specifically HPLC and GC, developed and evolved over time?
- Are you now more adept at identifying potential instrument malfunctions, interpreting complex chromatograms, or ensuring the integrity of your analytical data?
- When do you confidently recognise that an issue or result is beyond your current scope of practice and requires specialist intervention or escalation to a Training Officer?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Perform a range of chemical analytical techniques that provide evidence of product quality to ensure that samples meet the agreed specifications; analysing, interpreting, reporting and acting on the results. |
| # 2 |
Outcome
Perform a range of microbiological analytical techniques that provide evidence of product quality to ensure that samples meet the agreed specifications; analysing, interpreting, reporting and acting on the results. |
| # 4 |
Outcome
Write specifications for routine quality control and stability assessment based on relevant standards and guidance. |
| # 7 |
Outcome
Describe the requirements of data integrity related to quality control systems. |