Packaging of study products [Study Per­for­mance]

posted by Ohlbe – France, 2010-08-27 16:27 (5765 d 05:27 ago) – Posting: # 5858
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Dear Dan,

❝ In practice you need GMP certificate (because it is a manufacturing process) and you can perform this only in GMP-certified rooms


Except if you can benefit from the exception in Commission Directive 2005/28/EC, Article 9 (2). It depends of course how these provisions were transcribed in the German legislation (well, actually I wouldn't be that surprised if AMG were a bit rigid...)

❝ by qualified staff teached to respective SOPs etc.


Agreed (whether the product is left in the blister or not).

❝ In summary it is not as easy as you told.


I never said it's easy ;-)

Regards
Ohlbe
—
Regards
Ohlbe

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