The advisory board of the ECA Visual Inspection Group has worked on an update of its visual inspection guide. All participants of the ECA Conference Particles in Parenterals 2016 will receive a copy for free. Read more.
see
http://www.gmp-compliance.org/eca_mitt_05360_15266,15265,Z-PEM_n.html
The advisory board of the ECA Visual Inspection Group has worked on an update of its visual inspection guide. All participants of the ECA Conference Particles in Parenterals 2016, 28-29 September 2016 in Barcelona will receive a copy for free.
The paper, which is much rather supposed to be a reference than a strict requirement, covers Manual and Automated Inspection issues including qualification, validation and revalidation in the following chapters:
- Manual inspection
- Automated inspection
- Inspection of lyophilized product
- Defect Classes
- Evaluation of defect classes and trending
- Batch release
- Concerns regarding distributed product
The chapter on manual inspection has been extended to also address semi-automated inspection. The chapter on batch release now contains more information and explanation on AQL testing.
More information can also be found on the group’s webpage.
//////////ECA Guide, Visual Inspection, updated version, Particles event
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