Training activity: 1

Details

Write a test specification for:

• A starting material
  • On receipt
  • Retest
• A finished product

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

• Customer requirements
• Regulatory requirements
• Supplier status
• Testing requirements
  • Dosage form
  • Route of administration
  • Appropriate limits
  • Skip-lot testing
• Chemical testing
• Microbiological testing
• Sample handling and COSHH

Relevant learning outcomes

#	Outcome
# 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.