Training activity information
Details
Perform testing of packaging components to include two of the following:
- Ampoules
- Bottles
- Vials
- Stoppers
- Caps
- Labels
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
- Pharmacopoeial requirements
- ISO standards
- 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
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. |