Articles by John T. English - BioPharm International

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Articles by John T. English

Final Word: Should You Need FDA Approval to Make Manufacturing Changes?

If the agency modifies the rules, companies will have new opportunities to make process improvements
Feb 1, 2007

The pharmaceutical industry is well aware that FDA is trying to take a risk-based approach to enforcing the current good manufacturing practices (cGMP) regulations. This approach is driven by an economic reality: FDA simply does not have the resources to inspect every facility every other year. The organization doesn't even have the resources to inspect facilities every three years. Likewise, it is not cost-effective for our companies to carry out a complete, documentation-oriented revalidation for every process change, regardless of its significance or risk.

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