Publications

PDA Technical Reports

Thu, 28 May 2009 14:53:09 GMT

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PDA Electronic Products Terms of Use

Thu, 28 May 2009 13:46:36 GMT

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July/August PDA Letter

Mon, 11 Aug 2008 15:19:43 GMT

ray shaw pdf

Fri, 23 Jul 2010 16:51:43 GMT

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June 2010

Fri, 23 Jul 2010 09:56:35 GMT

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Industry Faces Challenges in Sterile Drug Manufacturing, Aseptic Processing

Fri, 23 Jul 2010 10:21:40 GMT

PDA Pharmaceutical companies continue to have issues with GMP requirements for aseptic processing, and the U.S. FDA, under its policy of swift, aggressive and effective enforcement, is employing its full range of enforcement tools to improve compliance in this area.

Top Ten Myths of Container Closure Integrity Testing

Fri, 23 Jul 2010 11:42:24 GMT

Three decades ago, testing a container closure system for integrity meant performing a product sterility test. As recently as ten years ago, container closure integrity testing (CCIT) meant microbial challenge tests, or in more progressive circles, dye ingress tests. Advances in package leak testing technology and shared research studies present a new opportunity to redefine CCIT.

European article - Figure 2

Wed, 02 Jun 2010 09:00:52 GMT

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European article - Figure 1

Wed, 02 Jun 2010 08:59:43 GMT

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Maintain Quality in Midst of a Merger at PDA/FDA Session

Fri, 23 Jul 2010 10:13:48 GMT

The date for the 2010 PDA/FDA Joint Regulatory Conference is drawing near. Scheduled for September 13-15 in Washington D.C., this year's conference theme focuses on how companies can maintain quality standards while dealing with mergers, acquisitions and new merging regulations.

May 2010

Tue, 01 Jun 2010 10:49:11 GMT

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Read the Full July/August Issue (Members Only)

Fri, 23 Jul 2010 15:47:49 GMT

PDA remembers Raymond Shaw in the July/August issue of the PDA Letter. An article about industry's recent challenges with aseptic processing and sterile drug manufacturing is featured. In "Hailey's Comments" resident Korean Regulator Hailey Park discusses the drug registration process in Korea. Articles about the upcoming 2010 PDA/FDA Joint Regulatory Meeting appear throughout the issue-look for the PDA/FDA logo. Be sure to check out photos from the cold chain and vaccines conferences in the "Faces and Places."

April 2010

Thu, 29 Apr 2010 15:30:25 GMT

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June Cover

Tue, 16 Jun 2009 10:13:26 GMT

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Podcasts

Wed, 04 Feb 2009 15:41:00 GMT

Web-exclusive content for the PDA Letter.

About PDA Letter

Tue, 09 Sep 2008 10:57:20 GMT

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2009 PDA Letter Insertion Order Form

Thu, 25 Sep 2008 13:07:22 GMT

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Authors Wanted

Mon, 11 Aug 2008 16:02:06 GMT

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Members Only Archives

Tue, 28 Oct 2008 13:29:41 GMT

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PDA Interest Groups & Leaders

Thu, 25 Sep 2008 11:21:00 GMT

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Recent Sci-Tech Discussions

Thu, 25 Sep 2008 05:46:34 GMT

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Regulatory Briefs

Thu, 25 Sep 2008 11:25:10 GMT

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Quality and Regulatory Snapshot

Thu, 25 Sep 2008 05:44:40 GMT

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Science and Technology Snapshot

Thu, 25 Sep 2008 05:43:26 GMT

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May 2008

Wed, 10 Sep 2008 07:48:24 GMT

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2009 PDA Annual Meeting Preview

Wed, 11 Mar 2009 08:45:17 GMT

Special PDA Letter preview of the 2009 PDA Annual Meeting.

PDA Journal of Science & Technology

Wed, 26 Aug 2009 13:19:24 GMT

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International Pharmaceutical Quality

Fri, 09 Jan 2009 08:10:49 GMT

International Pharmaceutical Quality and related IPQ publications will target the issues and challenges surrounding the international harmonization of pharmaceutical and biopharmaceutical regulation and help further the discussion about the regulatory approaches appropriate for advancing products and processes.

July/August 2009

Thu, 24 Sep 2009 13:00:28 GMT

THE PROCESS VALIDATION PARADIGM IS CHANGING and the implications for the way manufacturers control their processes and regulators inspect them are being assessed.

May/June Issue - FREE

Tue, 18 Aug 2009 13:27:03 GMT

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May-June 2009

Mon, 20 Jul 2009 14:15:38 GMT

ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic.

March-April 2009

Fri, 15 May 2009 11:06:19 GMT

DRUG MANUFACTURERS ARE REASSESSING HOW THEY MANAGE REGULATORY INSPECTIONS as they shift focus onto the challenge of conveying the strength of their quality systems to find and address problems and risks.

January-February 2009

Fri, 06 Mar 2009 09:13:18 GMT

THE REGULATORY STANDARDS FOR ASEPTIC PROCESSING ARE UNDER SCRUTINY as industry moves to interpret and implement the 2008 revisions to Annex 1 of the EU GMPs.

November-December 2008

Fri, 09 Jan 2009 09:38:29 GMT

A GLOBALLY COORDINATED RESPONSE TO THE DRUG SUPPLY CHAIN PROBLEMS is being called for, as the realization takes hold among the various stakeholders that the only effective and affordable option is a unified effort.

September-October 2008

Fri, 09 Jan 2009 09:53:30 GMT

THE IMPACT OF QUALITY BY DESIGN ON BIOTECH REGULATION is growing. An FDA biotech QbD pilot and industry mock initiatives are getting underway that will build on the experience gained in the small molecule area.

July-August 2008

Mon, 27 Oct 2008 10:44:24 GMT

THE IMPACT OF QUALITY SYSTEM PRINCIPLES ON INSPECTION PRACTICE is expanding in depth and breadth as EU and U.S. regulators seek to evolve their GMP guidance and compliance programs in line with the new ICH Q8-10 paradigm.

May-June 2008

Mon, 27 Oct 2008 10:38:16 GMT

EXPANDED FDA RESOURCES AND ENFORCEMENT TOOLS ARE NEEDED to allow the agency to handle the challenges of overseeing a global marketplace, FDA and its stakeholders are telling a newly receptive U.S. Congress.

March-April 2008

Mon, 15 Sep 2008 20:47:31 GMT

THE CHALLENGES IN CONTROLLING EXTRACTABLES AND LEACHABLES are driving drug and biologic manufacturers and their vendors to explore new ways of comparing experience and sharing information.

January-February 2008

Mon, 15 Sep 2008 20:49:51 GMT

THE REACH OF QUALITY SYSTEMS INTO THE SUPPLY CHAIN is drawing FDA attention as it looks for industry support in assuring ingredient quality in a complex global marketplace.

IPQ Banner

Fri, 09 Jan 2009 09:15:16 GMT

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November-December 2007

Mon, 15 Sep 2008 20:52:04 GMT

THE EU IS ASSESSING ITS API QUALITY INITIATIVES to see how they are working in practice.

September-October 2007

Mon, 15 Sep 2008 20:52:54 GMT

First Issue: APPLYING QUALITY BY DESIGN TO BIOPHARMACEUTICALS is testing the viability of the definitions that have been jelling in the small molecule context.

Bookstore

Fri, 22 Aug 2008 09:35:13 GMT

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