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In nearly all regions and industries, markets for products reflect the impact of globalization. The tactic of competing on price is increasingly giving way to a wider range of factors—including ...

Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls. Although no new statistics or sampling plans are explicitly required by Q10, it goes without saying ...