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

FDA and EU Extend QbD Pilot Program and Continue to Clarify Expectations for QbD

This article was originally published in The Gold Sheet

Executive Summary

FDA and EU regulators have announced a two-year extension of the QbD joint review pilot program and are continuing to harmonize their approaches to QbD in a series of recent guides. In one change regulators said that they will no longer accept the use of the term “key process parameter” in assessing criticality because of the misuse of the term.

You may also be interested in...



US FDA Allows Outsourcers To Compound Hydroxychloroquine As COVID-19 Drives Demand

The US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.

In Pandemic Response, Quality Experts Advise Drug Manufacturers Move Products To Local Sites

AstraZeneca emptied its warehouses in January. “We said, OK let us pack everything and get it out in the door,” said Tony Mire-Sluis, head of global quality. The firm is allowing only crucial personnel in plants, or those responsible for running a plant or moving products; all others are working from home.

Quality Experts Advise Industry To Move Products To Local Sites In Responding To COVID-19

Quality experts with AstraZeneca and Thermo Fisher describe how their companies are responding to the COVID-19 pandemic – but urge industry not to lose focus on monitoring unrelated drug products.

UsernamePublicRestriction

Register

PS000840

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