Regulation: Standards, policy, compliance, and enforcement for good manufacturing practices and good laboratory practices - Pharmaceutical Technology

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Inside Standards
Insider Solutions: A New Direction for USP?
November 2, 2009
With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.
Square Root of (N) + 1 Sampling Plan
October 2, 2009
Is the square root of (N) + 1 a statistically valid scheme?
Inside USP: Characterization of Heparin Products
October 2, 2009
USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.
Inside ICH–MHLW: Working Groups Ramp up Quality-based Implementation
September 2, 2009
Representatives of Japan's MHLW report on recent ICH activities and what the ministry expects from Q11.
Inside IPEC–Americas: Evaluating Excipient Stability
September 2, 2009
IPEC's new stability testing guide takes into account the full supply chain's storage conditions.
Searchable Databases
FDA Takes Action Against Maryland Veal Calf Dealer
FDA Issues 22 Warning Letters to Web site Operators
FDA Takes Action Against Dairy Farm and Owner
FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC
FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks

Last updated on Thu Nov 19 15:50:00 EST 2009

Standards & Regulations
Insider Solutions: A New Direction for USP?
With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.
Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure
The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
Safety versus Speed in Drug Development
The heightened focus on risk raises concerns about delays in approving new drugs.
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