08.09.2016

New Q&A Document on the Visual Inspection of Parenterals available

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The Visual Inspection Group, an Interest Group of the ECA Foundation, has developed a new document with frequently asked questions. The new Q&A document, which was compiled by the Group's Board, is now available for a free of charge download on the website.

For compiling the document the members of the Group were asked to provide their questions in February. These questions were then evaluated and answered by the Board Members.

The new document is structured as follows:

Manual Inspection
Automated Inspection
Qualification / Validation
Test sets
Re-Qualification
AQL-Tests
Defect Categorisation
Specific Products
Regulatory Affairs
Process Control / SPC

Some examples for the questions and the respective answers:

The grey portion of fully automatic control is often checked manually, to return not clearly or fully tested products back to the inspection process. Is it allowed to carry out this testing with the automated inspection machine?

From a GMP view, there are no restrictions. It is also important here that at the end a yield calculation and evaluation in the batch record appears. And there are also automated inspection systems that have already integrated the double inspection with multiple cameras.

In highly automated manufacturing lines for LVP flexible containers, the visual inspection process may/cannot comply to the standard visual inspection criteria e.g.: 5 sec inspection time, agitation of the container etc. Is this a compliance problem?

The requirements like 5 sec inspection time required by pharmacopoeias are addressing manually performed visual inspection. If the visual inspection is performed automatically, it is the company’s responsibility to ensure that the inspection via camera systems is as effective as a manual visual inspection via a validation (e.g. Knapp Test).

Should the AQL be inspected by QC or production

AQL manual inspection may be carried out by production staff (to avoid setting up a separate visual inspection team in QC) under a quality oversight or the quality unit. If performed by production operators, the AQL test should not be done by members of the team that was performing the 100 % visual inspection of the batch.

The new Q&A document is available for members in the members' area on the Visual Inspection Group website free of charge. Membership in the Group is also free of charge and merely requires a registration.

The Good Practice Guide "Visual Inspection of medicinal products for parenteral use", was also revised. The new Version 3.0 will be introduced at the ECA Conference Particles in Parenterals in Barcelona, Spain, from 28-29 September 2016. All delegates of the conference will receive a free copy.