Quality assurance for aseptic services videos

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A series of short videos about quality assurance in aseptic services

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 the SPSQA lunchtime webinar sessions.

Best practice aseptic processing

This 1-hour video explains how best practice aseptic processing provides assurance that aseptically prepared medicines are safe, effective, and are of the required quality. It also helps you reflect on your own practice and learn from examples where processes can fall short.

Supervising cleanrooms

This 21-minute video explores how to supervise cleanrooms to ensure compliance with aseptic best practice and with your local procedures. It explains the principles of supervision, identifies common barriers to good supervision and offers insight into how to be a good supervisor.

Developing effective standard operating procedures

This 33-minute video highlights the importance of robust standard operating procedures (SOPs) for the aseptic preparation of injectable medicines. It explains how SOPs are developed, written, and validated to ensure safe and consistent practices.

How a well-designed worksheet directs and controls the aseptic process

Well-designed worksheets are essential documents in pharmacy aseptic services. This 21-minute video will help you understand how worksheets can effectively direct and control aseptic processes, and how you might make improvements to the worksheets in your own unit.

Change management

Change management is a pillar of the quality management system in pharmacy aseptic services. This 31-minute video will help you understand the importance of controlling change within a change management process, and provides tips on how to approach change control in practice.

 

Capturing and trending data related to deviations in pharmacy aseptic services is vital for driving continuous quality improvement. This 15-minute video defines the term “deviation” and presents a case study example of a deviation management system. This can help you reflect on and challenge your current practices.

Investigating deviations and establishing root causes

Deviations in pharmacy aseptic services must be investigated to identify the root causes so that future deviations can be prevented.

This 19-minute video guides you through the deviation investigation process, including how to determine root causes. It also offers practical advice on writing a clear and effective investigation report.

Dealing with OOS microbiology results

This pair of videos explores the fundamentals of a specific type of deviation: managing out of specification microbiology environmental monitoring results in pharmacy aseptic units.

Part 1 is a 35-minute video discussing the effective triaging and trending of out of specification results and assessing the need for further investigation. Part 2 is a 42-minute video taking a deeper dive into the process of investigating and responding to out-of-specification microbiology monitoring results within your service.

Part 1

Part 2

Corrective and Preventive Action (CAPA)

This 21-minute video 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 difficulties.

Management review and KPIs

Periodic senior management review of the pharmacy aseptic services quality system is essential for assurance of quality, identifying areas for improvement, and meeting regulatory and governance expectations.

This 39-minute video covers the core principles of management review and guides you through the development and evaluation of Key Performance Indicators (KPIs) within your service. You’ll also learn how to escalate adverse indicators to key decision-makers effectively.

Self-inspection (internal audit)

Self-inspection, also known as internal audit, plays a vital role in monitoring effectiveness and driving improvement in aseptic services.

This 31-minute video covers the fundamentals of self-inspection and provides guidance on how to use audit findings to drive improvement.

Chemical and physical stability evaluation in aseptics

A good understanding of factors affecting chemical and physical stability is a key factor when assigning shelf life to products prepared in pharmacy aseptic services.

This 31-minute video guides you through the evaluation of chemical and physical stability data to support shelf-life decisions for medicines prepared within your service.

 

Update history

  1. updated introductory wording to the videos
  1. YouTube videos changed to Vimeo
  1. Addition of chemical and physical stability in aseptics video
  1. Published

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