Die ECA Visual Inspection Group hat die neue Version 5.0 finalisiert. Enthalten sind umfangreiche redaktionelle und inhaltliche Veränderungen, sowie ein neues Kapitel über die Inspektion von 'difficult-to-inspect" Einheiten und ausführliche Hinweise zum Vorgehen bei Partikelfund im AQL Test. Vorgestellt aus ausgegeben wird das neue Dokument auf der jährlichen Konferenz der ECA Visual Inspection Group, 22.-23. Oktober in Wien. Lesen Sie weiter.
If the visual inspection is carried out with an automatic inspection system (AVI), function tests should be carried out regularly. Does the AVI system still need to be requalified regularly?
During the validation and operation of fully automated inspection machines, there are always problems with high false reject rates, i.e. the incorrect rejection of good objects. Are there GMP requirements in this regard?
Der ICH E2D(R1)-Leitlinienentwurf zu "Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)" erreichte im Februar 2024 Schritt 2b des ICH-Prozesses und ging in die Konsultationsphase.
The ECA Visual Inspection Group has published the new version 4.0 of its guide on the group's website. In addition to some clarifications, version 4.0 also contains a completely new chapter.
What are the FDA requirements for equipment qualifications? This is a question that requires a more detailed look into the regulations. However, a current Warning Letter offers a more simple way for information.
As a participant of the GMP Training "Product Transfer", from 10-12 October in Munich, Germany, you will receive electronic example documents, templates and guidelines for site change projects.
In the 100% visual inspection of parenterals required by the pharmacopoeias, so-called test sets with different tasks and properties are used. Find out what these are and what needs to be taken into account.
