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Quality⁄Regulatory Affairs

The PDA Quality and Regulatory Affairs Department monitors the international and US regulatory landscape for new regulatory initiatives that would affect PDA members. The Regulatory Affairs Department notifies members of these guidances initiatives via the PDA Web site, PDA e-mails, and the PDA Letter. Relevant Guidelines areas of coverage include quality systems, risk management, PAT, dispute resolution, manufacturing, Chemistry and Manufacturing Controls (CMCs) and related Marketing Authorization submissions, and current Good Manufacturing Practices (cGMPs). The PDA Quality and Regulatory Affairs Department also publishes news to help PDA members understand and comply with the complex regulatory expectations of our global environment.

The department interacts with the U.S. FDA, The European Medicines Agency (EMEA), WHO, ICH, USP and numerous other regulatory bodies around the world. Through the PDA Regulatory Affairs and Quality Committee (RAQC), comments to guidances and original proposals other regulatory initiatives are made to regulatory bodies to promote science-based regulation(s) and harmonization.

For more information about the PDA Quality and Regulatory Affairs Department, contact Robert Dana, Vice President Quality and Regulatory Affairs at dana@pda.org.

Latest News

  • PDF2009 PDA Regulatory Affairs and Quality Control Committee Members
  • Health Authority Special Report: MHRA’s Risk-Based Inspections Seminar
    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
    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
    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
    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
    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
    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
    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
 
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