What are the differences between US and EU Pharmacopeias?

G

Grace74

#1
#1
Good Day,

Can someone tell me if there are any significant differences between the US and the EU Pharmacopeias, and if so, what are they?

Thank you for any assitance.
 
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Ronen E

Ronen E

Problem Solver
Moderator
#2
#2
Grace74 said:
Good Day,

Can someone tell me if there are any significant differences between the US and the EU Pharmacopeias, and if so, what are they?

Thank you for any assitance.
Click to expand...
Hello and welcome to the cove :bigwave:

A sample answer can be found at:

http://www.eiga.org/index.php?id=29...&tx_abdownloads_pi1[cid]=810&cHash=067ed9376e

Cheers,
Ronen.

Edit: Sorry, hyperlink doesn't work, so copy the entire thing into the URL line of your browser. Hopefully one of the moderators can fix that (thanks).
 
Ajit Basrur

Ajit Basrur

Leader
Admin
#5
#5
Grace74 said:
Good Day,

Can someone tell me if there are any significant differences between the US and the EU Pharmacopeias, and if so, what are they?

Thank you for any assitance.
Click to expand...
Welcome to the Cove :bigwave:

Wikipedia reference-linkPharmacopeia

Pharmacopoeia (American English: pharmacopeia) (literally, 'drug-making'), in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.

In a broader sense it is a reference work for pharmaceutical drug specifications.

Therefore, the medicines to be sold in a particular country have to be published by that country's respective Regulatory body.

For United States, it is the Wikipedia reference-linkUnited_States_Pharmacopeia and for European Union, it is the Wikipedia reference-linkEuropean_Pharmacopoeia.

Hope that helps !
 
G

Grace74

#6
#6
Thank you for the warm welcome and the information. I work for a biologic medical device company. We had our full 13485 audit last week. One of the auditors commented we really needed to reference the EU Pharmacopeia. We don't even reference the US Pharmacopeia. He couldn't really give me a reason except for "just because". I think it's silly to spend ~$1000 for something to sit on a shelf. I think as long as I can show there aren't any significant differences I'm going to push back on this.
 
Ajit Basrur

Ajit Basrur

Leader
Admin
#7
#7
Grace74 said:
Thank you for the warm welcome and the information. I work for a biologic medical device company. We had our full 13485 audit last week. One of the auditors commented we really needed to reference the EU Pharmacopeia. We don't even reference the US Pharmacopeia. He couldn't really give me a reason except for "just because". I think it's silly to spend ~$1000 for something to sit on a shelf. I think as long as I can show there aren't any significant differences I'm going to push back on this.
Click to expand...
There are some combination products that are Drug + Device and in those cases, the Pharmacopeia has to be referred for analysis of the drug substance.
 
G

Grace74

#8
#8
We currently are not doing drug/device combos, but I've heard through the grapevine that it has come up in R&D meetings. I just fail to see how this relates to our product.
 
P

pkost

Trusted Information Resource
#9
#9
If your device incorporates a drug then I can see the reasoning, but an auditors response of "just because" is rather sloppy
 
V

v9991

Trusted Information Resource
#10
#10
Grace74 said:
Thank you for the warm welcome and the information. I work for a biologic medical device company. We had our full 13485 audit last week. One of the auditors commented we really needed to reference the EU Pharmacopeia. We don't even reference the US Pharmacopeia. He couldn't really give me a reason except for "just because". I think it's silly to spend ~$1000 for something to sit on a shelf. I think as long as I can show there aren't any significant differences I'm going to push back on this.
Click to expand...
My guess is that... You might following ISO standards/guidance for establishing various activities in your process. Look if there are any equivalent monographs in USP/BP/EP .
btw, Relevance of pharmacopoeia in your context could be even certain general monographs/chapters pertaining to "compatibility of materials" and "extractables and leachables"; Pharmacopoeia also has certain monographs on metrology (measurements, weights, calbirations, validations) etc.,

Since you say it is pertaining to expectation set by auditor, if you can indicate specific category/type of device OR context of discussion, we would try to possibly suggest few points.

But generally speaking...differences exist in most of the places relevant to dossiers; (viz., no. of batches, stability, ) and data presentation&evaluation (viz., listing of impurities) ... and special areas of TSE/BSE certifications, etc.,and to the extent of emphasis on review comments,.

In the meanwhile, try to look into following references...
Pharmacopoeial Standards for Medicines in the Australia New Zealand Therapeutic Products Agency ​

http://www.anztpa.org/consult/pharmacopoeia.pdf


Pharmacopoeial Reference Standards
http://www.ipapharma.org/events/IPA%20-%20EDQM%20pdf/Antony%20Gomes%20-%20reference%20standards.pdf

Hope that it helps.
 
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