Training activity information
Details
Perform testing of starting materials to a pharmacopoeial or in-house specification to include:
- API
- Excipient
- Water
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.
Considerations
- Test specification
- 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 are the specific test procedures outlined in the relevant pharmacopoeial or in-house specification for the chosen starting materials (API, excipient, water)?
- What are the safety precautions and risk assessments associated with the chemicals and equipment involved in the testing?
- What principles underpin the analytical techniques used (e.g., titration, spectroscopy)?
- How should results be recorded, interpreted, and compared against the acceptance criteria in the specification?
- What are the data integrity requirements for laboratory testing and record-keeping?
- Discuss the specific starting materials and tests you will be performing with your training officer.
- Review the relevant pharmacopoeial monographs or in-house specifications and any associated SOPs.
- Ensure you understand the principles and procedures for each test method.
- Familiarise yourself with the safe operation of all equipment you will be using.
- Consider potential sources of error in the testing process and how to mitigate them.
In action
- As you perform each test on the API, excipient, and water, what specific steps are you taking?
- Why are you performing them in this order or using these particular techniques?
- What decisions are you making as you conduct the tests (e.g., adjustments to equipment, interpretation of observations)?
- What aspects of the testing process for each material feel intuitive, and where do you need to consciously follow the specification?
- How effective are your techniques in carrying out the required tests for each starting material?
- What challenges are you facing during the testing, such as equipment issues or unexpected observations?
- What are you learning about the practical application of pharmacopoeial or in-house specifications as the testing unfolds?
- How do the results you are obtaining relate to the expected quality of the starting materials?
- If you encounter unexpected results or difficulties, what alternative approaches are you considering (e.g., re-testing, troubleshooting equipment)?
- What support or guidance might you need if you are unsure about a step or an observation?
- Are you ensuring that your testing practices adhere to data integrity principles (e.g., accurate recording of observations)?
On action
- What specific analytical techniques did you use to test the API (Active Pharmaceutical Ingredient), excipient, and water?
- What were the key steps involved in each of the testing procedures you performed?
- How did you ensure that you were following the pharmacopoeial or in-house specification accurately?
- Did you encounter any challenges or unexpected results during the testing process?
- What practical skills in analytical testing did you develop or reinforce through this activity?
- How do the testing requirements differ for different types of starting materials (API, excipient, water) based on their properties and role in the final product?
- What is the importance of adhering to established specifications when testing pharmaceutical materials?
- How will you apply the knowledge and skills gained in performing these tests to future quality control activities?
- What aspects of starting material testing would you like to explore in more detail?
- How does this practical experience contribute to your understanding of ensuring the quality of pharmaceutical products from their initial components?
Beyond action
- Have you reflected on the specific tests you performed on the API, excipient, and water?
- How do your initial experiences of performing these tests compare with your understanding and practical skills in similar analytical techniques gained in later training activities or routine practice?
- Have you discussed the challenges or successes you encountered during these initial tests with colleagues? Has this provided new insights?
- How did this hands-on experience solidify your understanding of pharmacopoeial or in-house specifications and their practical application in the laboratory?
- Have the foundational analytical skills you developed in this training activity been built upon in subsequent activities, such as performing HPLC or GC analysis?
- How has this experience influenced your awareness of potential sources of error in laboratory testing and the importance of adherence to standard operating procedures?
- What fundamental analytical skills and techniques did you practice in this training activity that will be transferable to a wider range of quality control testing in your future practice?
- How will your understanding of the practicalities of testing starting materials inform your future role in quality assurance and ensuring product quality?
- What actions will you take to further develop your proficiency in these fundamental analytical techniques based on this revisited experience?
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. |