Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

EMA Proposal Would Give Popular Alternative For Pharmaceutical Water A Foothold in Europe

Executive Summary

The European Medicines Agency is inviting stakeholder feedback on a proposal to allow reverse osmosis as an alternative to steam distillation for making water for injections (WFI) for pharmaceutical manufacturing. EMA also would expand its water quality guideline to cover vaccines and advanced therapy medicinal products such as cell and gene therapies.

You may also be interested in...



Industry Guide Could Ease EU Adoption Of Reverse Osmosis For Pharmaceutical Water

Recent guidance from a pharmaceutical industry group should help manufacturers in the EU make the transition from using highly purified water and steam distillation to other methods for preventing microbiological contamination of pharmaceuticals such as reverse osmosis. The guideline also addresses the cost of using membrane technology versus distillation technology.

Quality Regulatory Updates In Brief: EMA, FDA, EDQM And WHO

EMA proposes updating methods for water for injection; FDA clarifies policies on first responders under new drug tracing law; EDQM lists top 10 API deficiencies; and WHO invites API manufacturers to participate in prequalification program.

EDQM surveys industry on RO for WFI

Should the European Pharmacopoeia let drug makers use reverse osmosis to produce water for injection? The European Directorate for the Quality of Medicines and Healthcare said April 1 that it is surveying industry on this question. EP requires distillation, while the U.S. Pharmacopeia allows reverse osmosis, although FDA imposes strict controls on it. The European Medicines Agency summarized the objections in a March 5, 2008, reflection paper: reverse osmosis cannot screen out contaminants smaller than water molecules, such as chlorine or volatile organic chemicals; and the reverse osmosis membrane can become, in effect, a bacterial fermenter by allowing a biofilm to form on its upstream side and possibly spread to the permeate side or secrete metabolic byproducts that could pass through the membrane. Reverse osmosis would be cheaper and more practical, and some say new technologies would make it safe. Responses are due May 30

Topics

UsernamePublicRestriction

Register

PS124342

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel