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Current Events

Cleaning Validation

Cleaning Validation

3/4 September 2020
Hamburg, Germany

Process Validation in the light of the revised Annex 15 and FDA Requirement

Process Validation in the light of the revised Annex 15 and FDA Requirement

6/7 October 2020
Berlin, Germany

ECA Validation Group


ECA´s Validation Group is providing a European wide networking platform for facilitating active discussions of the latest regulatory requirements and to identify and address technical issues and challenges regarding Process Validation and Equipment Qualification. Discussion/position papers and generic procedures are further supposed to provide an active support for a harmonised approach to common problems and issues.

In addition, it actively supports a harmonised approach by;

  • Providing guidance documents on topics of specific interest to Process Validation and Equipment Qualification
  • Developing discussion/position papers and generic procedures via expert working groups
  • Facilitating an effective and efficient communication between the pharmaceutical industry, suppliers, engineering companies and competent authorities regarding process validation and equipment qualification issues.

Achievements

The Validation Group has already developed the following guides which are available to members free of charge

Guidance: Good Practice Guide on Validation Guidance: Good Practice Guide on Validation Guidance: Good Practice Guide (Public Draft 2) : Integrated Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership Guidance: Good Practice Guide (Public Draft 2):
Integrated Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership

Current Projects

The Validation Group is currently working on the Final Version of the Good Practice Guide on Integrated Qualification & Validation.

Guidance: Good Practice Guide (Final Version) : Integrated Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership Guidance: Good Practice Guide (Final Version):
Integrated Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership