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New EU Draft Guideline Clarifies, Broadens and Deepens Expectations for GDPs

The EU’s new draft guideline on Good Distribution Practices (GDPs) makes a substantial contribution to the product manufacturer-to-patient component of the global regulatory community’s effort to clarify, broaden and deepen GDP regulatory expectations....

Regulatory Focus on Good Distribution Practices Intensifying Across the Globe

The focus on good distribution practices (GDPs) during regulatory inspections has increased dramatically recently, and the global regulatory community is working on a variety of fronts to refine GDP guidance, standards, regulations and the legislative framework to support them....

Membership & US Entry, GDPs, QRM Guidance and Traditional/Herbal Medicine Inspections Draw PIC/S Attention

FDA’s entry into the Pharmaceutical Inspection Cooperation Scheme (PIC/S) at the beginning of 2011 will be marked by the participation of Commissioner Margaret Hamburg at PIC/S’ upcoming 40th anniversary symposium on “Challenges and Future Perspectives” in Geneva, Switzerland in late May....

Australia’s TGA Publishes Updated Draft Guidance on Clearance of Products Manufactured Overseas

TGA has released for comment a draft guideline that clarifies its requirements for GMP compliance by overseas manufacturers and further harmonizes those requirements with other international regulatory bodies....

China’s SFDA Moving Toward Expanding Supply Chain Auditing and Filing Requirements

China’s State Food and Drug Administration (SFDA) has released a draft of a new regulation that would significantly expand the supply chain auditing and filing requirements for manufacturers of active pharmaceutical ingredients (APIs) and packaging as well as drug products....

Temperature and Storage Conditions Top the List of Major/Critical Deficiencies in MHRA GDP Inspections

Temperature and storage conditions were the most common Good Distribution Practice (GDP) deficiencies ranked “major” and “critical” by the UK Medicines and Healthcare products Regulatory Agency (MHRA) during inspections conducted from January to June of 2010....

US House Proposing to Equip and Fund FDA for Increased Global Oversight

Key players in the US House of Representatives have put on the table a draft of comprehensive legislation aimed at strengthening FDA’s recall and overseas inspection authorities and requiring new supply chain accountability for drug companies. The bill is intended to help FDA respond to the increasing challenges it faces in regulating a global pharmaceutical marketplace....

Willing Parties, Quality Agreements and Information From Suppliers All Needed For Supply Chain Risk Management, CDER’s Friedman Stresses

Willing parties, quality agreements and information from suppliers are all needed along with auditing programs in managing pharmaceutical supply chain risks, CDER Office of Compliance Division of Manufacturing and Product Quality (DMPQ) Director Richard Friedman stressed in addressing industry/regulator initiatives to strengthen supply chain integrity....

Cooperative Supply Chain Integrity Efforts Important to Support Advancing Track-and-Trace/Authentication Technologies and QC Analytical Methods

Broad-based cooperation vertically across the supply chain and horizontally across organizations and regions is important to help support the advancements in track-and-trace/product authentication technologies and QC analytical methods, CDER compliance official Richard Friedman emphasizes....

Update From FDA on its Secure Supply Chain Pilot Coming Soon; Regulation, Legislation and Guidance Efforts Advance in US and EU

A status update and further announcements from FDA on its “Secure Supply Chain” (SSC) pilot program, intended to help promote the safety of active ingredients and drug products imported into the US, is expected soon....
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