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Quality assurance for aseptic services videos

Published
Topics: Aseptic services

A series of short videos about quality assurance in aseptic services

Contents
  1. Using our best practice videos
  2. Best practice aseptic processing
  3. Supervising cleanrooms
  4. Developing effective standard operating procedures
  5. How a well designed worksheet directs and controls the aseptic process
  6. Change management
  7. Deviation management (data capture & trending)
  8. Investigating deviations and establishing root causes
  9. Dealing with OOS microbiology results
    1. Part 1
    2. Part 2
  10. Corrective and Preventive Action (CAPA)
  11. Management Review and KPIs
  12. Self inspection (internal audit)

Using our best practice videos

Our video topics are based on emerging themes and problem areas identified at aseptic preparation audits and from queries from Trusts. We provide them here so they can be viewed at any time.

These were originally created by the North West SPS QA team and have been periodically used during our lunchtime webinar sessions.

Best practice aseptic processing

This presentation explores the fundamentals of aseptic processing, describes best practices and includes examples where practices may fall short.

Supervising cleanrooms

This presentation explores the fundamentals of cleanroom supervision including process design and critical controls, barriers to success, and how to be an effective cleanroom supervisor.

Developing effective standard operating procedures

This presentation discusses and demonstrates the importance of robust standard operating procedures within pharmacy aseptic services and how they are developed and written.

How a well designed worksheet directs and controls the aseptic process

This presentation explores the importance of well designed worksheets in pharmacy aseptic services and how they can effectively direct and control aseptic processes.

Change management

This presentation explores the fundamentals of change management in pharmacy aseptic services, including the importance of change management within the quality system.

This presentation defines the term “deviation” and explains the importance of effective data capture. It includes a case study that demonstrates an example deviation management system.

Investigating deviations and establishing root causes

This presentation explores the process of investigating deviations, establishing root causes and writing an investigation report.

Dealing with OOS microbiology results

This pair of presentations explore the fundamentals of a specific type of deviation: manging out of specification microbiology environmental monitoring results within pharmacy aseptic units.

Part 1

Part 2

Corrective and Preventive Action (CAPA)

This presentation explores the fundamentals of Corrective and Preventive Action (CAPA) in pharmacy technical services. We define CAPA, demonstrate its importance, describe effective use and identify common deficiencies.

Management Review and KPIs

This session explores the fundamentals of Management Review and development and evaluation of KPIs. We explain the benefits of conducting management reviews and using KPIs to drive improvement and control risks, discuss the escalation of adverse indicators to key decision makers, and identify regulatory and governance expectations.

Self inspection (internal audit)

This presentation explores the importance of self inspection, the main aims and how to appropriately respond to findings.

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