Dr. Ingrid Walther
Pharma Consulting Walther
Referent:innen
Dr. Franz Schönfeld
Regierung von Oberfranken
Katharina Stoib
Roche Diagnostics
All times mentioned are CEST.
Zielsetzung
In addition to the regulatory expectations and the general structure and application of the ECA Contamination Control Guide, this workshop explains how to use the included template for a CCS document and examples for the practical creation of a CCS document. Practical experience will be shared how to use the template to integrate your existing system of contamination control measures and how to evaluate possible gaps.
Hintergrund
The final revision of EU GMP Annex 1 contains, among many other innovations and additions, a clear requirement for a contamination control strategy. This refers to a series of measures to control microbial load, pyrogens and particles, derived from the current product and process understanding, implemented to ensure process performance and product quality. The Contamination Control Strategy should include parameters and attributes related to APIs, excipient and drug product materials and components, facility and equipment operating conditions, in-process controls, final product specifications and associated methods and frequency of monitoring and control. A total of 16 elements to be considered is listed in Annex 1.
The requirement in the current Annex 1 for a CCS is the first time that an overarching concept has to be in place and been demanded of manufacturers that integrates the various contamination control measures into a coordinated concept. This concept considers these measures, which are often the responsibility of different areas of the company such as production, quality assurance or quality control, in their entirety. This takes account of the fact that these measures and individual concepts interact with each other and that changes often have an impact on other areas. Like a butterfly effect.
Therefore, the ECA has prepared a guiding document to support you in drawing up such a contamination control strategy. It can be used for both, the coordination of measures for an existing plant and for the creation of a CCS for a new plant.
The requirement in the current Annex 1 for a CCS is the first time that an overarching concept has to be in place and been demanded of manufacturers that integrates the various contamination control measures into a coordinated concept. This concept considers these measures, which are often the responsibility of different areas of the company such as production, quality assurance or quality control, in their entirety. This takes account of the fact that these measures and individual concepts interact with each other and that changes often have an impact on other areas. Like a butterfly effect.
Therefore, the ECA has prepared a guiding document to support you in drawing up such a contamination control strategy. It can be used for both, the coordination of measures for an existing plant and for the creation of a CCS for a new plant.
Zielgruppe
The workshop is aimed at all employees of the pharmaceutical industry who are involved in the preparation of a CCS and also at representatives of the regulatory authorities, involved in the inspection of the fulfilment of such requirements.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Inspector’s View on a CCS
- Requirements of Annex 1
- Inspector´s expectations
- Implementation: CCS integration in existing environment
The CCS Template – Practical Use Part 1
- The aim of the Guideline
- Structure of content structure in connection with Annex 1
- Structure of the Template/Attachment3
The CCS Template – Practical Use Part 2
- Practical Use - Filling in the Template
- Gap-assessment based on the Template
- Ready to present your CCS
Case Study: Use of the Guide and Template with Integration of Existing Risk Assessments and SOPs
- Practical use of the CCS Guide
- Evaluation of existing relevant documents
- Building an hybrid CCS by integrating existing Risk Assessments and SOPs
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