The ECA Contamination Control Strategy Guide - How to use? - Live Online Training A requirement of the revised Annex 1

The ECA Contamination Control Strategy Guide - How to use? - Live Online Training

Seminar Nr. 20128

All times mentioned are CEST.


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Walid el Azab, Lead of the ECA CCS Task Force, Steris Corporation, Belgium
Dr Rainer Gnibl, GMP Inspector, Government of Upper Bavaria, Germany
Isabelle Hoenen, Lilly, France
Robert Schwarz, FH Campus Vienna, Member of the ECA CCS Task Force, Austria
Dr Ingrid Walther,  Pharma Consulting Walther, Head of the ECA Annex 1 Task Force, Germany


In addition to the regulatory expectations and the general structure and application of the ECA's Contamination Control Guideline, this workshop explains how to use the parts and examples for the practical creation of a CCS and how to use it to integrate your existing system of measures and evaluate possible gaps.


The latest draft of the revision of EU GMP Annex 1, among many other innovations and additions, contains the following statement:
“Contamination Control Strategy (CCS) - A planned set of controls for microorganisms, pyrogens and particulates, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to active substance, excipient and drug product materials and components, facility and equipment operating conditions, in- process controls, finished product specifications, and the associated methods and frequency of monitoring and control.”

With the requirement of the revised Annex 1 for a “Contamination Control Strategy”, for the first time an overarching concept is demanded from the manufacturers that the various measures of contamination control are integrated into a coordinated concept that 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 into account the fact that these measures and individual concepts interact with each other and that changes often have an impact on other areas.

The ECA has therefore produced a guide to help you draw up such a Contamination Control Strategy. It is usable to coordinate measures of an existing plant as well as to create a CCS for a new plant.


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 who are involved in the inspection of such requirements.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Inspectors View on a CCS
Dr Rainer Gnibl, Government of Upper Bavaria
  •  Requirements from Annex 1
  •  Inspector’s expectations
  •  Implementation: CCS integration in existing environment
Beyond Annex 1 - Helpful Regulatory Documents for CCS
Robert Schwarz, FH Campus Vienna
  •  The EU-GMP Guideline itself
  •  FDA regulations
  •  Best practice papers
The ECA Guide – Structure and Use
Walid El Azab, Steris, Chair ECA CCS Task Force
  •  Multidisciplinary team work approach
  •  Guide scope & purpose
  •  Structure & use
Approach for a Gap Analysis
Isabelle Hoenen, Lilly
  •  Content structure
  •  Analysis
  •  Points to consider
The CCS Template – Practical Use
Dr Ingrid Walther, Chair ECA Annex 1 Task Force, Pharma Consulting Walther
  •  Content structure in connection with Annex 1
  •  Practical Use - Filling in the Template
  •  Ready to present your CCS


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