Quality & Regulatory Snapshot

Regulatory News: Ongoing Collaboration Between European Medicines Agency/U.S. FDA Regarding Orphan Drugs

Fri, 30 Apr 2010 11:19:20 GMT

May 2010The definitions of rare diseases and conditions differ regionally and are laid down in the respective regional legislations. According to the European legislative framework on Orphan Drugs, a severe disease or disorder is defined as "rare," when it affects less than 5 in 10,000 (respectively 1 in 2000) citizens of the European Union.

Advisory Board Watch: Steve Mendivil Discusses His Involvement With RAQC

Fri, 30 Apr 2010 11:13:11 GMT

May 2010
The PDA Letter spoke with Steve Mendivil, about his Regulatory Affairs and Quality Committee (RAQC) membership. Steve is an Executive Director of Corporate Quality EHS External Affairs at Amgen.

Hailey's Comments: The Structure of KFDA

Fri, 30 Apr 2010 08:49:55 GMT

May 2010
Have you worked with the Korea Food and Drug Administration (KFDA) before? I think that in most cases, you may have interacted indirectly with KFDA via your Korean partner. However, it is a fact that regulatory inspections are growing in numbers, and more KFDA inspectors will visit pharmaceutical manufacturing sites outside of Korea as the Korean drug regulations are becoming strict

Harmonization Report: Official ICH Training for Q8, Q9 & Q10 in Europe

Tue, 23 Feb 2010 09:12:01 GMT

March 2010 Training endorsed by the International Conference on Harmonisation (ICH) endorsed training on integrated implementation of the ICH Q8, Q9 and Q10 guidelines will kick off on June 2-4 in Tallinn, Estonia.

Meet Hee-Young "Hailey" Park-Our New Intern

Tue, 23 Feb 2010 08:37:56 GMT

March 2010 I am pleased to meet all of you through the PDA Letter. My name is Hee-Young Park from Korea Food & Drug Administration (KFDA). And some of you might remember me with the English name, Hailey. I became a new family member of PDA at its Bethesda location in December of 2009. I would like to tell you my story.

Health Authority Special Report: Interested Parties Briefing Meeting

Tue, 26 Jan 2010 12:37:53 GMT

February 2010An overview was presented by the European Medicine Agency Inspectors' Working Group on developments in GMP and related guidance.

A Look Back and a Look Forward

Mon, 04 Jan 2010 14:04:55 GMT

January 2010 It's mid-December as we write this article for the January 2010 issue of the PDA Letter, and believe it or not, the "ought's" of the 21st Century are behind us. Fast forward to December 2009, and like the Roman god Janus, we'll take a look back at some of 2009's significant regulatory happenings and see if we can do a little prediction of what might happen in 2010 as well.

Advisory Board Watch: RAQC Activities for 2009

Mon, 04 Jan 2010 12:18:01 GMT

PDA's Regulatory Affairs and Quality Control Committee (RAQC) is comprised of 23 voting PDA members, with global representative delegations from the Asia Pacific, European and North American regions.

2009 Archives

Mon, 04 Jan 2010 12:10:27 GMT

N/A

Health Authority Special Report: Israel Joins PIC/S

Mon, 02 Feb 2009 13:48:53 GMT

On November 12, 2008, Israel's Pharmaceutical Inspectorate was unanimously voted to join the pharmaceutical Inspection Cooperation Scheme (PIC/S).

Interest Group Briefing: A Discussion With Two IG Leaders

Thu, 29 Jan 2009 09:56:53 GMT

February 2009
Mike Long is the leader of PDA's Quality Risk Management (QRM) Interest Group, which was formed in late 2008. Anders Vinther, PhD, became the new leader of PDA's Quality Systems (QS) IG in 2008. Both answered a few questions about their respective IG's for the PDA Letter.

Supply Chain Guidance: CBER Import FAQs

Mon, 12 Jan 2009 08:38:19 GMT

January 2009On November 19, 2008, the U.S. FDA Center for Biologics Evaluation and Research updated their guidelines for importing regulated products in the United States.

Guidance News: U.S. FDA Posts New Level 2 Guidance on the cGMP Q&A Website

Fri, 09 Jan 2009 16:22:47 GMT
January 2009
he U.S. FDA launched the drug cGMP Q&A section of its website as part of the 21st century initiative. The goal is to provided timely answers to questions about the meaning and application of cGMPs to drug products. PDA will publish updates to the website as they become available.

A Look Back at 2008, and Forward to 2009

Fri, 09 Jan 2009 16:11:45 GMT
January 2009
2008 was a busy year on the regulatory front. The year began with PDA submitting comments on two U.S. FDA proposals relative to annexes to ICH Q4B and the proposed changes to the U. S. GMPs. In addition, we also commented later in the year on FDA's Draft Guidance for Industry entitled, Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. We currently have a Task Force of PDA volunteers drafting comments for the newly released FDA Draft Guidance on potency testing for cellular and gene therapy products.

International Pharmaceutical Quality: Analysis of U.S. FDA, EU Authority Inspection Findings

Mon, 17 Aug 2009 13:25:08 GMT
September 2009
The May/June issue of International Pharmaceutical Quality provides an incisive, up-to-date analysis of recent U.S. FDA and EU authority inspection findings and enforcement actions.

2008 Archives

Fri, 09 Jan 2009 14:47:54 GMT
N/A

PDA Commenting on U.S. FDA Validation Draft, Workshops to Follow

Mon, 01 Dec 2008 14:21:37 GMT
November/December 2008
On November 18, the Federal Register contained a notice of the availability of the long-awaited draft guidance entitled, Process Validation: Principles and Practices. Jointly published by the Centers for biologics, drugs and veterinary medicine, the draft guidance outlines the general principles and approaches that the U.S. FDA considers to be appropriate elements of process validation for the manufacture of medicinal products, including active pharmaceutical ingredients (APIs).

An Interview with the Co-chairs of the RAQC

Mon, 13 Oct 2008 16:15:27 GMT
October 2008
PDA Regulatory Affairs and Quality Committee (RAQC) co-chairs Steven Mendivil and Stephan Roenninger gave an interview to the PDA Letter about being the new leaders of RAQC. Steven is the Executive Director of Global Quality, Environment, Health, Safety Compliance at Amgen and is a member of PDA's Board of Directors. Stephan is Global Quality Manager at F. Hoffmann - La Roche. They recently became co-chairs of the PDA RAQC when former chairZena Kaufman's term ended. Zena is the Divisional Vice President of Abbott Quality and Regulatory at Abbott.

In Print: The Cost of Quality

Mon, 08 Sep 2008 16:13:58 GMT
September 2008
Not unexpectedly, benchmark data on the cost of quality (CoQ) is not readily available, mainly due to the fact that few companies have implemented systems that would permit reasonably accurate estimation of the CoQ. In a recent article it was estimated that up to Euro 140bn of annual global pharmaceutical sales are subject to some form of economic evaluation, which in itself is a key driver for industry to drive cost efficiency in its operations.

Regulatory Trends

Mon, 08 Sep 2008 15:59:59 GMT
July/August 2008
Recalls pertaining to sterility concerns can be caused by a number of factors. Recently the U.S. FDA compiled the specific reasons for Class II recalls related to drug product sterility concerns in 2006 and 2007. Overall, 17 products were involved in this preliminary analysis. Of these, 7 recalls were the result of "non-sterility" and 10 the result of "lack of sterility assurance."

Regulatory Trends: Root Cause: Sterility Related Drug Recalls

Thu, 13 Nov 2008 09:24:58 GMT
July/August 2008
Recalls pertaining to sterility concerns can be caused by a number of factors. Recently the U.S. FDA compiled the specific reasons for Class II recalls related to drug product sterility concerns in 2006 and 2007.

Proposed Legislation Provides FDA with Additional Resources

Tue, 11 Nov 2008 14:36:03 GMT
June 2008
Over the course of 2008, the U.S. FDA's ability to protect the American public from unsafe and ineffective products because of inadequate resources has come under increased scrutiny. Already, the U.S. Congress has held several hearings on the situation prompted by adverse events from products entering the United States from overseas suppliers and the Agency's own report regarding internal scientific and manpower shortfalls [Editor's Note: See thePDA Letter, February 2008, p. 25.]

Interest Group Report: Inspection Trends/Regulatory Affairs Interest Group

Tue, 11 Nov 2008 14:09:07 GMT
June 2008
The following is a report from two interest group meetings at the 2008 PDA Annual Meeting.

PQRI Update: Establishing the Science for Regulations

Mon, 01 Dec 2008 09:28:02 GMT
April 2008
PQRI Update Establishing the Science for Regulations Since 1999, the Product Quality Research Institute (PQRI) has established itself as the premier organization for providing a neutral environment where industry, academia and the FDA collaborate on pharmaceutical product quality research and development in support of policy relating to the regulation of drug products.

PDA Comments Analysis: Annex 1 Comments

Tue, 11 Nov 2008 15:18:47 GMT
April 2008
In April 2006, PDA submitted comments to EMEA regarding proposed changes to the May 2003 version of Annex 1, "Manufacture of Sterile Medicinal Products." The purpose of this article is to compare the original key comment points submitted by the PDA versus the final EMEA document published on Feb. 14, 2008 and effective March 1, 2009.

Six Regulatory Documents and a Trip Make For an Unusually Busy Week

Tue, 11 Nov 2008 15:05:45 GMT
April 2008
Welcome to another edition of the Quality and Regulatory Snapshot. As I write this, I'm at 35,000 feet somewhere over the Atlantic Ocean on my way home after a very successful PDA/EMEA Conference in Budapest, Hungary. This Conference was attended by over 400 people, and over 50 regulators from all across Europe were present, either as attendees or presenters. Congratulations to the Program Committee, chaired by Steve Bellis, David Cockburn and Lothar Hartman for assembling such an outstanding program. Thanks also to all the speakers who took time out from their day jobs to prepare their presentations and share their knowledge and perspectives with the attendees. In next month's issue of the PDA Letter you will be able to read more details on the Conference. We hope to be able to bring you the third PDA/EMEA Conference sometime in the future-stay tuned for news on this.

A Glimpse Into the PDA Regulatory Process

Thu, 13 Nov 2008 16:32:23 GMT
March 2008
To be or not to be: that is the question. Famous lines penned by William Shakespeare. How do they apply to PDA and this months Quality and Regulatory Snapshot? Good question.

Health Authority Special Report: RABS Risks and Rewards - A Discussion with FDA's Rick Friedman and Brenda Uratani

Tue, 18 Nov 2008 11:07:42 GMT
July/August 2008
In recent years, Restricted Access Barrier System(RABS) designed and operated under very strict criteria have emerged as the next best separative technology behind isolators.

PQRI Update: PQRI Working Group for Post Approval Changes for Sterile Products

Mon, 17 Nov 2008 08:52:26 GMT
February 2008
The task of the Product Quality Research Institute (PQRI) Working Group for Post Approval Changes for Sterile Products was to assess the risk of change.

China in the News and The Place for PDA QS Training

Wed, 12 Nov 2008 10:01:35 GMT
February 2008
This article details some significant historical GMP issues which could impact the quality of drug substances and products manufactured in and exported from China.

Health Authority Special Report: Year-Long Study Finds U.S. FDA Science and Mission at Risk

Mon, 17 Nov 2008 09:01:14 GMT
February 2008
A subcommittee of the U.S. FDA's Science Board, an advisory panel for the Office of the Commissioner, cast doubt on the Agency's scientific and technological capacities to fully support FDA's core regulatory functions and decision making throughout product life cycles, today and during the next decade.

Interest Group Briefing: Jentges to be Europe Co-chair of Inspection Trends/Regulatory Affairs IG

Wed, 12 Nov 2008 14:34:47 GMT
January 2008
Barbara Jentges, PhD, has agreed to be the Europe co-chair of the Inspection Trends/ Regulatory Affairs Interest Group. The U.S. co-chair is Bob Dana, who has been leading this Interest Group for many years.

Regulatory Trends: Top 10 Sterile Product Surveillance Inspection Findings

Wed, 12 Nov 2008 14:50:16 GMT
January 2008
The following data are the top U.S. FDA inspector findings from routine GMP inspections specific to the manufacture of sterile drug products during the Agency's fiscal years 2005-2007. Tara Gooen, Chemical Engineer, Offi ce of Compliance, CDER, pulled the data and submitted it to PDA.

In Print: Disinfection Programs - A Primer

Thu, 13 Nov 2008 12:00:34 GMT
January 2008
A reliable cleaning and disinfection program is an essential component of microbiological contamination control in pharmaceutical manufacture.

Health Authority Report: Chinese Pharmaceutical Industry Evolution

Mon, 01 Dec 2008 14:31:41 GMT
November/December 2008
[Author's Note: This article captures the presentation I delivered on behalf of Tang Minhao, Deputy Director of the Shanghai Municipal Food and Drug Administration at the 2008 PDA/FDA Pharmaceutical Ingredient Supply Chain Conference in Washington, September 10-12. The presentation was originally given by Mr. Minhao for the State Food and Drug Agency (SFDA) at the PDA/FDA Quality Systems workshop in Shanghai, April 24-25, 2008. There it was agreed that I would present Mr. Minhao's talk on his behalf. These short notes represent my interpretation of the key messages given in the presentation, which is available at the "members only" section of www.pda.org.]