ECA Good Practice Guide streamlines Equipment Qualification - Numerous Sample Documents

Equipment qualification has been conducted for 20 years already and is a "Must" in modern manufacturing practice. Nevertheless, almost every company has its own concept and terminology. As a result, equipment qualification is still a controversial topic and regularly leads to ambiguities in communication, even with suppliers. 

The Validation Group of the ECA Foundation therefore aims at drawing more attention to the topic of equipment qualification and rationalizing qualification with a Good Practice Guide. This goal is to be achieved through improved cooperation and mutual understanding between pharmaceutical customers and suppliers in projects involving manufacturing systems, equipment and utilities. The Group believes that more emphasis needs to be placed on qualification activities, which are time-consuming and expensive and can sometimes delay the market launch of new products or equipment expansions. A separate chapter also considers the integration of process validation as part of a qualification.

The now final document of the Good Practice Guide was developed over the last two years. In addition to the actual guideline, it comprises nine appendices with, among other things, sample documents and structures such as

• User Requirement Specification Template Example 
• Supplier Qualification
• DQ and Verification Planning Tools and Template examples
• Change Management Template Example
• Deviation Management Template Example
• Project Quality Plan Template Example
• Qualification Documentation Template Example
• Categorisation of Manufacturing Systems Template Example

A technical glossary is the ninth appendix to the sample documents.

The new ECA Guide entitled "Integrated Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership" in its final version will be presented and discussed in detail during the ECA Launch Conference on 27/28 October 2020. Participants of the conference, which will take place Live Online, will therefore have the opportunity to get to know the contents in detail and applications (case studies) - and will also receive a copy of the Guide as a PDF download.