Cetacea Oct 16, 2014:

@ Steffen 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.

Jacek Konopka Oct 16, 2014:

Hallo Steffen,
Ist Ok. Danke

Einen schönen Tag noch.

Steffen Walter Oct 16, 2014:

@ Susan 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.

Steffen Walter Oct 16, 2014:

@JacekKonopka 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.

Susan Welsh (asker) Oct 15, 2014:

Here it popped up again... Protokoll mikrobiologische Prüfung Wfl Ch.: 20033

Jacek Konopka Oct 15, 2014:

Kein ABER mehr, nicht für heute.
Gute Nacht, Herr Steffen Walter.

Jacek Konopka Oct 15, 2014:

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.....

Susan Welsh (asker) Oct 15, 2014:

thanks 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.

Steffen Walter Oct 15, 2014:

Related systems 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.

Susan Welsh (asker) Oct 15, 2014:

bullet points 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!)

Steffen Walter Oct 15, 2014:

If still in doubt, ... ... I'm afraid you have to ask the client what 'Wfl' means.

Steffen Walter Oct 15, 2014:

Other bullet points Are there any other bullet points mentioned in this context?

Steffen Walter Oct 15, 2014:

Error or not, ... ... 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?).

Susan Welsh (asker) Oct 15, 2014:

Not an OCR error I have the PDF, and it's definitely written Wfl - not with capital letters.

Steffen Walter Oct 15, 2014:

Could this be ... ... a scanning/OCR error for "WFI"? Note the reference to the 'Herstellung von WFI (Wasser für Injektionszwecke)' at http://www.gmp-navigator.com/nav_news_2403_6720,6771,6767.ht...