Quality Control —
Training activity: 4

Details

Perform testing of the following types of pharmaceutical products to include HPLC or GC analysis:

• Sterile
• Non-sterile

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 relevant learning outcomes help you contextualise your preparation for performing chemical and microbiological analytical techniques on these products?
• How will this activity help you understand the relationship between analytical results and the writing of specifications for routine quality control?
• What do you need to know about data integrity requirements for quality control systems before you begin your laboratory work?
• How does the successful analysis of sterile and non-sterile products contribute to the wider aim of ensuring patient safety?

What do you anticipate you will learn from the experience?

• What specific insights do you hope to gain from engaging with HPLC or GC analysis, particularly regarding instrument operation and sample preparation?
• Based on what you already know about the task, which technical skills in analysing, interpreting, and reporting chromatograms are you looking to develop further?
• What do you expect to learn about the differentiation in testing requirements for sterile versus non-sterile dosage forms?
• How do you anticipate this experience will improve your ability to act on results when they do not meet the agreed specifications?

What actions will you take in preparation for the experience?

• What specific points will you discuss with your Training Officer to gain a clear understanding of the expectations for this activity?
• What possible challenges, such as instrument troubleshooting, achieving required sensitivity, or interpreting complex data, might you face, and how are you planning to handle them?
• How do you feel about embarking on this training activity, and are there specific practical aspects of chromatography that cause you apprehension?
• Which Standard Operating Procedures (SOPs), pharmacopeial monographs, or safety risk assessments must you review to ensure you are fully prepared?
• How will you ensure you are working within your scope of practice, and who are the senior analysts or supervisors you should approach if you encounter out-of-specification results?
• What steps will you take to ensure that your record-keeping aligns with data integrity principles like ALCOA+?

In action

What are you doing?

• As you perform the chemical analytical techniques (HPLC or GC), why are you choosing specific preparation steps for sterile versus non-sterile samples to ensure product quality?
• What decisions are you making regarding instrument parameters—such as flow rate or injection volume—to ensure the samples meet the agreed specifications?
• How are you approaching the interpretation of chromatograms in the moment, and why is this method the most effective for acting on the results?
• Which aspects of the laboratory setup feel intuitive, and which parts—such as ensuring sterile samples are not contaminated during preparation—require more conscious effort?

How are you progressing with the activity?

• How effective are your current actions in producing reliable evidence of product quality for the specifications you are testing against?
• What challenges are you facing while the analysis is unfolding, such as instrument baseline drift or unexpected peaks, and what are you learning from them?
• How does this specific testing activity connect to your existing knowledge of writing specifications for routine quality control or stability assessment?
• What are you learning about the practical application of data integrity principles as you record your observations and system suitability results in real-time?

How are you adapting to the situation?

• If you encounter an unexpected or out-of-specification result, what alternative analytical approaches are you considering to investigate the cause?
• What support or guidance might you need in this moment to ensure your analysis remains compliant with the required standards?
• How are you ensuring that you are working within your scope of practice, particularly when deciding whether to escalate a questionable result to a supervisor?
• Are you adapting your behaviours to ensure that data integrity requirements, such as the use of second checks or accurate time-stamping, are being met as the activity progresses?

On action

What did you notice?

• How would you summarise the key points of the experience, including the specific preparation and analysis steps you followed for the sterile and non-sterile pharmaceutical products?
• What were the key results obtained, and how did they compare to the agreed chemical or microbiological specifications you were testing against?
• Were there any specific events, actions, or interactions in the laboratory that felt significant, such as a discussion regarding the interpretation of a chromatogram with a senior analyst?
• How did you feel during the process of ensuring that the testing provided valid evidence of product quality?

What did you learn from the activity?

• What specific skills or knowledge did you develop regarding the operation of HPLC or GC instruments and the analysis of results for different dosage forms?
• Were there any unexpected challenges—such as instrument drift or sample contamination—and what did you learn from how you handled them?
• In what ways did your reflection-in-action (the decisions you made during the analysis) influence the final outcome or the reliability of the data?
• How does this experience help you understand the requirements for post-programme practice, specifically regarding the Clinical Scientist’s role in ensuring patient safety through Quality Control?
• How did this activity improve your ability to describe and apply data integrity requirements (such as ALCOA+) to your laboratory records?

What will you take from the experience moving forward?

• What areas for continued development have you identified, such as a need to refine your technique for writing specifications or interpreting complex microbiological data?
• How can you apply the learning from this activity—specifically regarding Quality Risk Management and the investigation of results—to your routine practice in the department?
• What ‘next steps’ will you take to support the assimilation of what you have learned about the differences in testing requirements for sterile versus non-sterile products?
• What support or resources (e.g., pharmacopeial monographs or further instrument training) do you need to further develop your competence in these analytical techniques?
• Based on this experience, what would you do differently next time you are required to act on results that do not meet the agreed specifications?

Beyond action

Have you revisited the experiences?

• How does your current understanding of performing HPLC or GC analysis compare to your initial attempts, and what observable behaviours have you assimilated into your practice since then?
• In what ways have you compared these laboratory experiences with what you observed during Observed Training Activities (OTAs) to refine your own analytical techniques?
• How has revisiting reflections from related tasks—such as writing specifications or auditing data integrity —deepened your understanding of the chemical and microbiological evidence needed for product quality?
• Have you engaged in professional storytelling with peers or senior analysts regarding the complexities of chromatography results for different dosage forms? Has this exchange transformed your view on how to effectively ‘act on results’?

How have these experiences impacted upon your current practice?

• How are you ensuring that you do not see this testing activity as an isolated incident, but rather as a building block for your overall competence in pharmaceutical quality control?
• How has the practical experience of testing against specifications influenced the way you now write or review specifications for routine quality control and stability assessment?
• How is the learning gained from these analytical tasks supporting your preparation for ‘in-person’ assessments, such as a Case-based Discussion (CBD) on data integrity or a Direct Observation of Practical Skills (DOPS) related to analytical measurements?
• How has your awareness of data integrity and the importance of accurate record-keeping evolved since you first began using automated chromatography systems?

How might these experiences contribute towards your future practice?

• What transferable skills, such as critical data interpretation, technical troubleshooting of specialist equipment, and adherence to GMP/GDP standards, are you developing through this activity?
• How will your practical proficiency in performing complex chemical and microbiological analysis contribute to your future role as a Clinical Scientist responsible for ensuring patient safety?
• Based on your revisited experiences, what clear actions have you identified for your continued professional development in the area of pharmaceutical analysis and Quality Risk Management?
• How will your understanding of the relationship between laboratory results and product release inform your future involvement in quality assurance and the investigation of questionable results?

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.