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Archive for ‘April, 2011’

“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....
April 27, 2011 | Posted in International, Purity/Potency/Identity/Stability, Shipping & Storage, Supply Chain/GDPs, The News in Depth | Read More »

IPAC-RS is Advancing GMP Consciousness Among Inhalation Product Component Suppliers; New PS 9000 Will Allow Certification

The multi-faceted effort by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) to instill the quality management concepts detailed in its component GMP guidelines into the complex supply chain for orally inhaled and nasal drug products (OINDPs) is continuing to bear fruit....
April 25, 2011 | Posted in GMP Policy, Inhalation, International, Product Type Specific, The News in Depth | Read More »

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....
April 20, 2011 | Posted in International, Supply Chain/GDPs, The News in Depth, Track and Trace | Read More »

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....
April 19, 2011 | Posted in International, Supply Chain/GDPs, The News in Depth, Track and Trace | Read More »

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....
April 19, 2011 | Posted in General, International, Supply Chain/GDPs, The News in Depth | Read More »

Human Factors/Usability Gaining Prominence in Combination Product Review

Human factors/usability analysis is gaining prominence in the dialogue between combination product manufacturers and regulators. At issue is an effective pathway for companies to follow in conducting and submitting the analysis and for regulators to follow in reviewing it....
April 12, 2011 | Posted in CMC Review Policy, Combinations, Product Type Specific, The News in Depth, US/Canada | Read More »

More Guidance Forthcoming from FDA’s Office of Combination Products on CMC & GMP Expectations

FDA’s Office of Combination Products (OCP) will be sharing its growing knowledge base through new guidances and updates to its existing library that will help CP manufacturers better understand the regulatory expectations and navigate the shoals of marketing clearance....
April 1, 2011 | Posted in CMC Review Policy, Combinations, GMP Policy, Product Type Specific, Product Type Specific, The News in Depth, US/Canada | Read More »

Communication with Reviewing Authorities Key to Combination Product Success in Europe and Japan

Communication with reviewing authorities is critical in navigating the combination product regulatory shoals in Europe and Japan as it is in the US. However, the communication channels are not always well-marked, and they differ in each of the three ICH regions....
April 1, 2011 | Posted in Asia, CMC Review Policy, Combinations, Europe, Product Type Specific, The News in Depth | Read More »

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