Regulatory Roundup: PQRI and FDA present Process Drift Workshop, and More. - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup: PQRI and FDA present Process Drift Workshop, and More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The Product Quality Research Institute (PQRI) and the US Food and Drug Administration are hosting a joint workshop called Process Drift: Detection, Measurement, and Control in the Manufacture of Pharmaceuticals, in December in Bethesda, Maryland. The workshop will address: a life-cycle approach to monitoring manufacturing performance that assures prompt detection and correction of meaningful variation; technological and management system approaches to better control process variation and mitigate product variability; and the impact of process drift on product performance, safety, and efficacy. Several industry and regulatory leaders are on the roster.

 

The Medicines Quality Monitoring surveillance program, a colloboration of the US Pharmacopeia (USP), Ghana Food and Drugs Board (FDB), and US Agency for International Development (USAID), uncovered substandard and counterfeit versions of 13 antimalarial medicines in multiple locations across Ghana. The program was established in 2008 and is implemented by USP’s Promoting the Quality of Medicines (PQM) initiative. According to a USP press release, the program uncovered a counterfeit version of Novartis’ Coartem, a widely used antimalarial, in 2009. The discovery of the counterfeits resulted in a nationwide recall of all 13 drugs, including publicizing the names of the outlets where they were found.  

 

This week, the steering committee and expert working groups of the International Conference on Harmonization have been meeting in Japan to discuss current harmonization efforts, including the implementation of the quality guidelines and the draft of the Q11 guideline on the Development and Manufacture of Drug Substance. Post-meeting summaries are expected soon.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here