The advisory board of ECA’s Interest Group for Visual Inspection is working on a revision of a document with frequently asked questions with regard to visual inspection of parenterals.
see
http://www.gmp-compliance.org/enews_05379_ECA-Visual-Inspection-Groups-works-on-new-FAQ-Document_15266,15265,15221,15160,Z-PEM_n.htmlregard to visual inspection of parenterals.
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.
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