Bioequivalence and Bioavailability Forum

Packaging of study products [Study Per­for­mance]

posted by Ohlbe – France, 2010-08-27 16:27 (5774 d 03:55 ago) – Posting: # 5858
Views: 6,942

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

Complete thread:

• Packaging of study products janmacek 2010-08-27 09:35 
  • Packaging of study products Ohlbe 2010-08-27 10:22
    • Packaging of study products Dr_Dan 2010-08-27 11:58
      • Packaging of study products janmacek 2010-08-27 13:29
      • Packaging of study productsOhlbe 2010-08-27 14:27
  • Packaging of study products Pavidus 2010-08-27 13:17
    • Packaging of study products Ohlbe 2010-08-27 14:18