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Explanation: Just an educated guess (see discussion).
See, for example,
http://www.fda.gov/ICECI/Inspections/InspectionGuides/Inspec... "THE 8 TYPES OF WATER ARE: 1. Non-potable 2. Potable (drinkable) water 3. USP purified water 4. USP water for injection (WFI) 5. USP sterile water for injection 6. USP sterile water for inhalation 7. USP bacteriostatic water for injection 8. USP sterile water for irrigation"
I don't find that strange at all. On the contrary, I'd say this new occurrence confirms your educated guess. Water for injection is produced in batches, and each batch must be tested to make sure there is no microbial growth.
Strange - this new occurrence raises doubts again as to whether 'water for injection' is really meant here. The 'Ch.' bit should stand for 'Charge' (batch), though.
Ich verstehe Ihre Anmerkung nicht. Meine Kommentare mögen "negativ" erscheinen, beruhen aber auf dem Kontext dieser Frage, und daraus ergibt sich nun mal, dass Ihre im Referenzeintrag genannten Quellen für den vorliegenden Fall irrelevant sind.
Steffen im UNTERSCHIED zu uyuni, dessen Amnerkungen IMMER oder fast immer objektiv sind, kann ich nicht verstehen, was Sie dazu bewegt, Kommentare, die NUR KOMMENTARE SIND, negativ zu formulieren. UYUNI ist ein Kollege, der nun mal seine Ansicht zum Ausdruck bringt. Das kann ich verstehen. Dieser Kollege war mehrmals recht freundlich, jetzt ist er mit mir / meinem Kommentar nicht einverstanden. Ok, ich verstehe dies ABER.....
You may very well be right. I am not very knowledgeable in this subject, unfortunately, and the agency I'm working for is clueless. So I'll put it as a suggestion, and say they should query their client.
Obviously, CIP (cleaning in place?) and WCBs (working cell banks?) are just other, related systems you would expect to find at a pharmaceutical manufacturing site. That said, water for injection would fit nicely into the picture.
Not under "planned changes," but the part before that was "substantial changes," and included such things as "Inbetriebnahme CIP-Anlage" and "Nutzung der Ressourcen des XXX für die Herstellung und Bereitstellung von WCBs, die in der Fermentation eingesezt werden können." (Thanks, Steffen, for fixing my subject categories. I looked for "Pharmaceuticals" under P in the list... and didn't find it!)
... this could still be "Water for injection", with the F written in lower case (für/for) and the l (lower-case L) resembling a capital I (perhaps a typo?).
Explanation: Just an educated guess (see discussion).
See, for example,
http://www.fda.gov/ICECI/Inspections/InspectionGuides/Inspec... "THE 8 TYPES OF WATER ARE: 1. Non-potable 2. Potable (drinkable) water 3. USP purified water 4. USP water for injection (WFI) 5. USP sterile water for injection 6. USP sterile water for inhalation 7. USP bacteriostatic water for injection 8. USP sterile water for irrigation"