Training activity: 2

Details

Critically appraise a plan for product validation activities for a new product or process change

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

• Mixing trials and statistical analysis
• Cleaning validation including toxicology and risk to patients
• Process validation
• Documentation
• Scale up
• Sampling and sampling strategies
• Local standard operating procedures (SOPs)
• Equipment validation

Relevant learning outcomes

#	Outcome
# 1	Outcome Describe the working practices of pharmaceutical production.
# 2	Outcome Apply the principles of good manufacturing practice (GMP) to the development of new products.
# 3	Outcome Perform a range of manufacturing activities, using specialist equipment, in accordance with requirements for GMP and pharmaceutical quality management systems.
# 4	Outcome Apply the principles of supplier approval and quality assessment to evaluate a range of starting materials and packaging components.
# 5	Outcome Perform activities to support safe storage and distribution of medicinal products applying the principles of Good Distribution Practice (GDP).
# 6	Outcome Apply the principles of quality risk management to the manufacturing process.