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.