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SFDA Releases Revised “Good Supply Practices” Guideline

China’s State Food and Drug Administration (SFDA) has released a revision of its good distribution practices guideline – which SFDA terms “good supply practices” (GSPs) – that will take effect at the beginning of June. Firms will have three years to come into full compliance.  After that time, non-compliant firms will no longer be able […]

Glass Integrity Threats for Injectables Probed at Wholesale and Specialty Pharmacy Levels

Pharmaceutical manufacturers are beginning to probe deeper into the glass integrity threats to injectable products occurring downstream at the wholesale and specialty pharmacy levels, beyond their traditional reach....

USP Releases New Draft General Chapter on Good Distribution Practices and Supply Chain Integrity

USP has released for comment a new draft general chapter <1083> titled “Good Distribution Practices – Supply Chain Integrity” that will be expand its series of information chapters addressing various aspects of the pharmaceutical supply chain. The formal proposal will be published in March/April issue of Pharmacopeial Forum.  Comments are due by May 31. An advance […]

Ireland’s IMB Publishes Drug Transport and Storage Guide

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WHO, USP and PDA Make Substantial Contributions to GDP Guidance Canon

The international pharmaceutical community is continuing to expand and refine its guidance for good distribution practices (GDPs) to give industry the tools it needs to protect and assess product quality in the face of the many hazards of a complex global supply chain....

Congressional Bills Address FDA Supply Chain Oversight

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Drug Industry Survey Reveals Wide Disparity in Approaches to Controlling Glass Quality

A PDA-sponsored survey of drug and biologic manufacturers reveals a wide disparity among the practices and approaches being taken to ensure the quality of glass vials and syringes and the products they contain....

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....

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....
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