ECA Visual Inspection Groups works on new FAQ Document

Recommendation
16-18 September 2025
Barcelona, Spain
Organisation of a GMP-compliant Site Change
The webpage of ECA's Interest Group for Visual Inspection contains several sources for giving advice in the field of visual inspection of parenterals. Besides the practical guidance paper, it contains an online discussion forum and a document with frequently asked questions. It has become clear though, that many of the questions in the forum recur and that these questions have already been answered in the FAQ document. It was therefore decided to restructure the FAQ document: the questions will now be sorted by topic to make the document easier to read. Also, in a group survey in February 2016 everybody was asked to send additional questions. The advisory board is now working on selected new questions which will be added to the restructured questions & answers document. The revised document will contain the following elements:
- Manual inspection
- Automated inspection
- Qualification/Validation
- Test sets
- Requalification
- AQL Testing
- Defect categorisation
- Special products
- Regulatory affairs
It is planned to finish the document in summer 2016, but at the latest during a face-to-face meeting at the next group event in September 2016 in Barcelona. It will be made available to all group members afterwards.
Related GMP News
03.07.2025The USP has revised the General Chapter <1231> on Pharmaceutical Water
25.06.2025Deficiencies in the Water System: Warning Letter to US Manufacturers of OTC Products
11.06.2025Warning Letter to Chinese Manufacturer due to serious Sterility and Hygiene Deficiencies
04.06.2025FAQs regarding Cross Contamination
04.06.2025GMP Deficiencies at French Sterile Manufacturer
14.05.2025Process Validation and Pharmaceutical Water Deficiencies at a US Manufacturer