The new version of the GMPs Annex 1 published by the European Commission on 22 08 2022 has major updates, in both its structure and its content. This session focuses on probably the most important of them: Your Contamination Control Strategy. This new document required by European the Health Authorities becomes the main entry door of all audit and inspection for sterile and also non sterile Pharmaceutical Companies. How to establish this document? How to design it? How to manage its own life cycle? How it participates to Sterility Assurance and Continuous improvement of Quality? Gap Analysis and Gap Assessment of the new annex 1 are the basis to start…
Course description
This training will start by reviewing the main requirements inside the new European GMPs Annex 1 and their link with the CCS documented concept. So, This training course will start by focusing on the chapter 2, explaining the key points to find necessarily in your CCS.
In a second time, we will give you different approaches to build your CCS and more, to establish a synthetized document. Whatever your context whatever your activities, theses different approaches are useable and useful for all of you.
This training course will explain also how to use this living document in term of Quality Assurance Improvement in order to improve year by year, day by day your level of Sterility Assurance.
Course outline
The process of revision of the Annex 1 and the link with the CCS Concept
What is it? Why is it needed?
- The CCS and the Official version of the Annex 1:
Study of the different paragraphs concerned.
- Development and documentation of a CCS:
An approach model to build your CCS and the different possibilities of its summarize
One CCS or more than one on a same site?
- Continuous improvement of the CCS:
Definition of the KPI or QPP impacting CCS performance
Trending of the data
Periodic review
- Interactive session:
- Questions and Answers
The course will be illustrated from specific situations met by the speaker in Pharmaceutical companies.
Learning objectives
The main objective of this session is to bring to the attendees a good understanding of what is a CCS and its function inside a pharmaceutical site and to bring some practical tools to establish your first version and also to do a continuous improvement of this document.
Who should attend
This training is intended for Managers and Assistants of Department involved such as Quality Assurance, Sterility Assurance, Production, Facilities, Engineering, Auditors, Qualified Persons and all support functions involved in Contamination Control Strategy
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