Packaging of study products [Study Per­for­mance]

posted by janmacek – Czech Republic, 2010-08-27 15:29 (5774 d 18:36 ago) – Posting: # 5853
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Dear Dan,

dividing the blister with scissors is hopefully not a manufacturing process. And the requirement of a GMP certificate for this simple process would be an exaggeration. As a patient, I am always carrying two tablets of my medicine in my wallet, and I am perfectly able to cut the blister without the GMP certificate!
Of course, the packaging and administration must be performed according an SOP and should be documented, there is no discussion about it.

With best regards,

Jan

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