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Multifaceted Falsified Medicines Directive Cleared in Europe; Implementation Will Pose Challenges for Industry and Regulators

Legislation adopted by the EU Council on May 27 will significantly strengthen the EU’s ability to detect falsified medicines and prevent their entry into the legitimate supply chain by adding new requirements in four main areas: ● safety features ● supply chain and good distribution practices (GDPs) ● active substances, and ● Internet sales....

Differences in National Shipping Requirements Challenge International Pharma

Pharmaceutical companies are wrestling with how to address the differences in country-specific regulatory requirements for shipping of their products, particularly regarding the allowance for minor excursions from the labeled storage conditions....

“Stability Budget” to Assure Quality During Drug Distribution Proposed by PDA Task Force with ICH Adoption in Mind

A “stability budget” is being proposed by a PDA task force as a viable approach for industry in its efforts to fill an important gap in assuring the quality of pharmaceutical products through the full-length of their distribution process....

Complying With Serialization Mandates Requires Long Lead Times, Experts Warn

Serialization experts are warning pharma companies that compliance with looming serialization requirement deadlines will require long lead times....

GS1 Global Standards Gaining Traction as Drug Serialization Deadlines Loom

GS1’s globally harmonized serial number approach continues to gain traction as pharmaceutical manufacturers seek to navigate the complicated maze of international regulatory requirements and comply with their looming deadlines....

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....

California’s Findings of Gaps in Heparin Recalls Highlighted at FDA Track and Trace Workshop

Evidence of the gaps in the 2008 heparin recall process uncovered by the State of California underscores the need for a track and trace system for prescription drug products, CA State Board of Pharmacy Executive Officer Virginia Herold maintained at an FDA-sponsored public workshop on February 15-16 at its White Oak, MD campus....

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....

More Guidance on Transport Storage Conditions Targeted by EMA

The European Medicines Agency (EMA) is proposing to expand its guidance on transport storage conditions to better address the challenges of an increasingly complex ingredient supply and product distribution chain....

Active Ingredient and Starting Material Supply Chains in Focus in Draft Revision to EU GMP Guide Chapter 5

The European Commission (EC) has released for comment a revision to EU GMP Guide Chapter 5 on production that provides new requirements for control of active ingredient and starting material supply chains, including reports documenting periodic supplier audits for inspector review....
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