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


EDQM surveys industry on RO for WFI

This article was originally published in The Gold Sheet

Executive Summary

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

You may also be interested in...

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

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.

Sickle Cell Gene Therapy May Need New US-Backed Payment Program, Grogan Suggests

Former senior advisor to President Trump warns that failure to reform drug pricing practices has seriously handicapped prospects for reimbursing cell and gene therapy under existing US payer programs.

Ready, Set, Guidance: FDA Releases Final Details Ahead Of ASCA Pilot Launch

A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.




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