Quality⁄Regulatory Affairs

2009 Quality/Regulatory News - Europe

Tue, 12 Jan 2010 09:37:48 GMT

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2009 PDA Regulatory Affairs and Quality Control Committee Members

Tue, 10 Nov 2009 08:58:47 GMT

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Health Authority Special Report: MHRA's Risk-Based Inspections Seminar

Tue, 07 Jul 2009 10:44:09 GMT

July/August
round 260, mostly UK delegates attended this public seminar on May 22 in London. The Medicines and Healthcare products Regulatory Agency (MHRA) gave a first-hand insight into its current approach to risk-base inspections. The seminar covered the inspection practices for Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) and Good Pharmacovigilance Practice (GPvP). In the field of risk-based inspections, the MHRA provides thought leadership among other European agencies. The high turnout reflected the interest in and the importance of the event.

International Pharmaceutical Quality: The Dialogue Turns to Regulatory Inspections . The March/April issue is available at: www.ipq.com

Tue, 16 Jun 2009 14:22:49 GMT

June2009
The increasing diversity of inspectors and regulatory agencies with which drug manufacturers must deal and the shift to a more quality systems-oriented compliance paradigm are forces prompting firms to clarify and refine their practices for inspection handling.

IG Briefing: Inspection Trends/Regulatory Affairs Interest Group Reviews FDA Inspection Findings

Tue, 16 Jun 2009 14:15:33 GMT

June2009
The Inspection Trends/Regulatory Affairs Interest Group met on April 22 during the 2009 PDA Annual Meeting.

A Look at the Past, Future of Regulatory Affairs

Tue, 16 Jun 2009 14:05:42 GMT

June2009
It's the end of May as I write this update, and I realized it's been some time since I had an entry for the Quality and Regulatory Snapshot. (In the next issue of the PDA Letter, you'll be able to read some of my thoughts and reflections of the first half of the year in my alter ego-that of being responsible for PDA's training and education programs.) I pondered a bit about what this column should address, and I thought I'd try to follow a similar theme as I will do in next months in the TRI Update section-what's gone on in the past few months, and what may lie ahead.

Health Authority Special Report: Agency Focuses On Strategies To Better Predict, Prevent Economically Motivated Adulteration

Thu, 21 May 2009 10:48:31 GMT

May 2009
The U.S. FDA is developing strategies and standards to better prevent adulteration and counterfeiting within the drug, medical device, cosmetic and food industries.

International Pharmaceutical Quality: The Dialogue turns to Annex 1: Visit www.ipqpubs.com for the full issue

Mon, 13 Apr 2009 10:41:39 GMT

April 2009
The challenges of interpreting and implementing the European Union's revised GMP Annex 1 on the Manufacture of Sterile Medicinal Products are prompting closer scrutiny of the foundation on which the annex and other aseptic processing regulatory standards are based.

Health Authority Special Report: EMEA Creates International Liaison Officer

Thu, 26 Feb 2009 10:40:52 GMT

March 2009
In recognition of the increasingly global nature of the pharmaceutical industry and its regulation, the EMEA has appointed an International Liaison Officer whose chief responsibility will be to create a clear strategy for developing the Agency's relationship with international stakeholders. Effective January 1, 2009, the new position was filled by Emer Cooke, previously Head of the EMEA Inspections Sector.

Quality Regulatory News - Europe 2008

Wed, 14 Jan 2009 13:40:14 GMT

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PDA Interest Group Survey

Mon, 08 Sep 2008 15:59:17 GMT

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Regulatory Affairs and Quality Committee (RAQC)

Mon, 11 Aug 2008 15:17:18 GMT

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PDA Regulatory Affairs and Quality Control Committee Members

Tue, 23 Feb 2010 15:05:26 GMT

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PDA Regulatory Affairs and Quality Control Committee Members

Tue, 03 Feb 2009 10:52:33 GMT

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Regulatory Comments

Sun, 07 Sep 2008 14:26:05 GMT

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Paradigm Change in Manufacturing Operations-(PCMO)

Wed, 02 Sep 2009 13:42:01 GMT

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Regulatory Comments

Mon, 11 Aug 2008 15:17:25 GMT

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2010: PDA Comments on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

Fri, 05 Mar 2010 10:07:51 GMT

PDA is pleased to offer comments on the draft Guidance for Industry, "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products."

2010: PDA Comments on Current Good Manufacturing Practice Requirements for Combination Products

Thu, 18 Feb 2010 09:36:14 GMT

PDA is pleased to offer comments on the prposed rule under 21 CFR Part 4, Docket No. FDA-2009-N-0435-0004 in the matter of "Current Good Manufacturing Requirements for Combination Products, f/k/a Docket No. FDA-2008-D-0409.

PDA Comments on Postmarketing Safety Reporting for Combination Products / FDA-2008-N-0424

Thu, 04 Feb 2010 13:36:41 GMT

PDA is pleased to offer comments on the proposed rule under 21 CFR Part 4, "Postmarketing Safety Reporting for Combination Products."

PDA Comments on Recommendations for the Evaluation of Animal Cell Cultures as Substrates for the Manufacture of Biological Medicinal Products and for the Characterization of Cell Banks

Tue, 29 Sep 2009 10:23:44 GMT

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FDA Comments on Federal Docket Management System Docket FDA-2009-D-0179

Wed, 29 Jul 2009 09:34:49 GMT

PDA comments on the Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products.

2009: PDA Comments on the Revised TSE Note for Guidance

Tue, 30 Jun 2009 14:39:16 GMT

PDA comments on the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (Doc. Ref. EMEA/410/10/01 -- Rev. 4, 21 February 2008

2009: PDA Comments on Securing the Drug Supply Chain

Wed, 15 Apr 2009 15:10:37 GMT

PDA comments on the Draft Guidance for Industry on Standards for Securing the Drug Supply chain -- Standardized Numerical Indentification for Prescription Drug Packages

2009: PDA Comments to EDQM Pharmaeuropa Chapter XXXX:2031

Mon, 06 Apr 2009 09:24:55 GMT

PDA comments to EDQM on Pharmaeuropa Volume 21, No. 1, January 2009, proposed revisions to Chapter XXXX:2031, "Monoclonal Antibodies for Human Use."

2009: PDA Comments to EDQM on Pharmaeuropa Chapters 2.6.16 and 5.2.3

Mon, 06 Apr 2009 09:21:10 GMT

PDA comments on Pharmaeuropa Volume 21, No. 1, January 2009 on Proposed Revisions to Chapter 2.6.16, "Test for Extraneous Agents in Biological Products," and Chapter 5.2.3, "Cell Substrates for the Production of Biological Products."

2009: PDA Comments on the Process Validation Guidance

Fri, 20 Mar 2009 12:38:49 GMT

PDA's official comments along with verbatim comments made by PDA members on the Draft Guidance for Industry on Process Validation: General Principles and Practices. Verbatim comments submitted by PDA Members have not been approved by the PDA Regulatory Affairs and Quality Committee or the PDA Board of Directors. They do not reflect official PDA comments. They are provided for educational proposes only.

2009: PDA Comments on EU Guidelines to GMP, Draft Annex 13

Thu, 29 Jan 2009 10:37:48 GMT

PDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use, Draft Annex 13, Manufacture of Investigational Medicinal Products

2009: PDA Comments on Draft Guidance on Potency Testing of Cellular and Gene Therapy Products

Mon, 12 Jan 2009 14:28:45 GMT

PDA comments on Draft Guidance for Industry on Potency Testing of Cellular and Gene Therapy Products

2008: PDA Comments on Draft Guidance for Parametric Release

Fri, 06 Mar 2009 16:10:46 GMT

PDA comments on the Draft Guidance for Industry on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes

2008

Fri, 11 Jul 2008 09:36:02 GMT

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2008: PDA Comments on EU Guidelines to GMP, Draft Annex 11 (Computerised Systems)

Thu, 15 Jan 2009 10:22:00 GMT

PDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use, Draft Annex 11, Computerized Systems

2008: PDA Comments on EU Guidelines to GMP Chapter 4

Wed, 14 Jan 2009 09:31:07 GMT

PDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use

2008: PDA Comments on ICH Q8

Mon, 15 Sep 2008 12:34:58 GMT

PDA comments on the Draft Guidance ICH Q8 Annex, Pharmaceutical Development

2008: PDA Comments on GMP Draft Annex 2

Fri, 11 Jul 2008 09:36:12 GMT

PDA Comments on GMP Draft Annex 2: Manufacture of Biological Medicinal Product for Human Use

Regulatory Affairs and Quality Committee

Sun, 07 Sep 2008 14:38:27 GMT

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2008: PDA Comments on Proposed Changes to Drug Product GMPs for Finished Pharmaceuticals

Fri, 11 Jul 2008 09:36:35 GMT

PDA Comments on Proposed Changes to Drug Product GMPs for Finished Pharmaceuticals

2008: PDA Comments on ICH Draft Guidance on Q4B

Fri, 11 Jul 2008 09:36:16 GMT

PDA Comments on Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3 on Test Particulate Contamination: Subvisible Particles General Chapter

RAQC Info2

Fri, 11 Jul 2008 09:23:43 GMT

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comments

Fri, 11 Jul 2008 09:36:07 GMT

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2007 Regulatory Comments Archive

Fri, 11 Jul 2008 09:34:35 GMT

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2006 Regulatory Comments Archives

Fri, 11 Jul 2008 09:33:09 GMT

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2005 Regulatory Comments Archive

Fri, 11 Jul 2008 09:29:06 GMT

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2004

Fri, 11 Jul 2008 09:26:24 GMT

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2003

Fri, 11 Jul 2008 09:26:17 GMT

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Quality & Regulatory Snapshot

Mon, 15 Sep 2008 14:23:54 GMT

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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

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2008 Archives

Fri, 09 Jan 2009 14:47:54 GMT

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Quality and Regulatory News - America

Fri, 01 May 2009 16:31:33 GMT

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2009 Quality and Regulatory News

Wed, 06 Jan 2010 10:45:41 GMT

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Guidance for Industry: Q8 (R2) Pharmaceutical Development

Tue, 08 Dec 2009 11:38:07 GMT

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2008 Quality and Regulatory News

Tue, 05 May 2009 13:56:41 GMT

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2007 Quality and Regulatory News

Fri, 01 May 2009 16:40:14 GMT

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2006 Quality and Regulatory News

Fri, 01 May 2009 16:37:29 GMT

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Quality/Regulatory News - Europe

Mon, 11 Aug 2008 15:22:23 GMT

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2009 Quality/Regulatory News - Europe

Tue, 12 Jan 2010 16:08:29 GMT

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2008 Quality/Regulatory News - Europe

Thu, 30 Jul 2009 09:12:18 GMT

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2007 Quality/Regulatory News - Europe

Thu, 30 Jul 2009 09:00:04 GMT

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2006 Quality/Regulatory News - Europe

Mon, 11 Aug 2008 16:51:42 GMT

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Quality/Regulatory News - Asia

Mon, 11 Aug 2008 15:22:29 GMT

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2007 Quality/Regulatory News - Asia-Pacific

Mon, 11 Aug 2008 17:19:49 GMT

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Interest Groups

Sun, 21 Sep 2008 17:18:20 GMT

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Task Forces

Tue, 16 Sep 2008 07:54:22 GMT

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Surveys

Mon, 11 Aug 2008 15:17:55 GMT

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Cleaning Validation Sampling Recovery Practices Survey

Mon, 24 Nov 2008 14:00:05 GMT

For those who missed the first announcement of the new survey on Cleaning Validation Sampling Recovery Practices, we are offering you an opportunity to participate in this important survey.

PDA Interest Group Survey

Mon, 08 Sep 2008 15:59:17 GMT

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Links to Global Health Authorities and Organizations

Mon, 11 Aug 2008 15:49:55 GMT

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