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Pharmaceuticals/Vetrinary paranterals


QUESTION: Dear Dr Anisfeld

We have a manufacturing line for production of Human parenteral solution ( ampoules and vials ) , we have a customer who need to produce some paranterals for veterinary use e.g. analgin , doxacycline  
according to my Knowledge it is prohibited by FDA and European guidelines but during negotiation , I could not find any guideline that mention any thing like this
can you help me please

Best Regards

ANSWER: I'd like to answer you, but I do not understand your question.
What exactly do you believe is prohibited by FDA and EMA?

---------- FOLLOW-UP ----------

QUESTION: Dear Dr Anisfeld

is it allowed to produce Veterinary parenteral products in the same line that produce Human products?
Did any Guideline refer to this issue

Best Regards

Absolutely this is permitted (except for the manufacture of pesticides).
US GMPs 21CFR211 atarts:

</i>Sec. 211.1 Scope.  
(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals.</I>

The title of the EU GMPs states that it is for Human and Veterinary Medicines.

I hope this helps.  


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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