Training activity: 4

Details

Trend and critically evaluate physical and microbiological environmental monitoring results and develop action plans to correct any failures and prevent a recurrence

Type

Entrustable training activity (ETA)

Evidence requirements

Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion. ​

Reflection at multiple timepoints on the trainee learning journey for this activity.

Considerations

• Relevant regulatory requirements and National standards
• Local SOPs
• Action and warning test limits
• Pharmaceutical microbiology:
  • Microorganisms, microbial growth (form and actions of microbes)
  • Sources of microbiological contamination
  • Potential risks from microbial contamination (pathogens and infection risks)
  • Physical monitoring including particle counts and pressures
• RCA and CAPA
• Contamination control strategies
• Roles of staff involved in the production process
• Appropriate corrective actions
• Change control
• Risk assessment
• Prioritisation of actions

Relevant learning outcomes

#	Outcome
# 2	Outcome Perform a range of tests to ensure the quality of aseptic products.
# 3	Outcome Interpret monitoring results and trends and take appropriate action to correct out of specification results.
# 4	Outcome Critically evaluate the design, installation and PPM of an aseptic unit and LAFCs/Isolators.
# 6	Outcome Apply risk management techniques in the context of aseptic medicines.