7 replies to this topic

[Simon]

I wasn't sure where to post this, I'll move it later if needs be.

Does anyone know what European Pharmacopoeia is? Baby language explanation very much appreciated.

Thanks,
Simon

[Franco]

I wasn't sure where to post this, I'll move it later if needs be.
Does anyone know what European Pharmacopoeia is?

Hi Simon,
EU Ph is a compendium of analytical standards and analysis methods for raw materials and packaging materials to be used in the pharma industry
EU Pharmacopoeia
Sometimes food manufacturers specifications refer to EU Ph, or US Ph just to make sure that purity of the ingredient fits the purpose or packaging materials complies with higher purity standards than usual.

[Simon]

Many thanks to SDF's European correspondent.

Cheers,
Simon

[Simon]

I've found out a little bit more about EU Phr. The norms is basically about approval of material in contact with pharmaceutical products. I had assumed that if a material was suitable for direct contact with food then it would automatically be suitable for pharmaceutical products. In this case the product is actually a vetrinary product. Apparently not, an element of EU Phr. also includes testing the material with blood.

What's that saying?

ASSUME - Makes an ASS out of U and ME.

Regards,
Simon

[Franco]

I had assumed that if a material was suitable for direct contact with food then it would automatically be suitable for pharmaceutical products.

Pay attention, the reverse is true ! Pharma requirements are usually more stringent that food & feed.

Edited by Franco, 26 November 2004 - 06:57 AM.

[Simon]

Pay attention, the reverse is true ! Pharma requirements are usually more stringent that food & feed.

I think so mate.

Regards,
Simon

[Charles Chew]

EU Pharmacopoeia - are guidelines and references on anything that has got to do with Pharmaceutical Materials and Products.

It would probably concern some products that we intend to make in future. With regards to Packaging, Franco is correct to say that EU Pharma guidelines are VERY stringent since it has directly got to do with ppl's HEALTH.

Those familiar with Pharma-GMP would know that Label Control and Sterility of Processing / Packing including Direct-Contact Packaging Materials are all essential elements.

EU Pharma is essential to control quality of Pharma Products going into and out of EU.

CHarles CHew

[WayToJoe]

Good afternoon,

 

I was going to post a new topic regarding "Pharmacopoeia" but why not bring back this post from 2004.  I have been doing some research on this topic but I am not able to find any detail.  I see edition 9 can cost some money which may be the route I take but would like to search around before I make the commitment.

 

We are a SQF level 2 certified facility that manufactures flexible packaging for variety of markets.  I have been working with a lab to ensure compliance for EU migration (10/2011) and was curious about pharmacopoeia. 

 

Does any one have any reading material to help understand what this standard means and what procedures are required?

 

Thank you

Joe