17/18 November 2021
Parenterals must be 100% visually inspected. This is a clear requirement of the pharmacopoeias, just as it is clear that containers with particles must be sorted out. But do the particles found always have to be identified?
Such an examination is not mandatory. The decisive factor here is how the particles have been classified. A classification as "major" is possible according to the European Pharmacopoeia 5.17.2 RECOMMENDATIONS ON TESTING OF PARTICULATE CONTAMINATION: VISIBLE PARTICLES. In this case, testing is not mandatory. Initially, it is primarily a matter of sorting out such objects. Thus, a categorisation of defects is expected. This can also be found in the Annex I Draft: "Defect classification and criticality should be determined during qualification and based on risk and historical knowledge."
Critical defects require investigation or clarification. This will also be found in the new Annex I: "Any critical defect identified should trigger an investigation as it indicates a possible failure of the original inspection process". If particles are classified as critical, they should be identified even if no action limit is exceeded. If particles are not classified as critical, identification is not seen as necessary. However, some companies see it differently and identify found particles in any case.
However, it also plays a role if one suddenly finds an unusually large number or conspicuous particles. Then something like that should be investigated in any case - what kind of particles they are and where they come from? Trending is necessary for this. Trending is a basic requirement of the GMP guidelines.
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Fundamentals of Visual Inspection
17 February 2022
Further guidance on the visual inspection of parenterals can also be found in the Good Practice Guide of the ECA Visual Inspection Group. The guidance is free of charge and just requires registration on the website.