Training activity: 2

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

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.