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Drugmakers facing a European GMP inspection should be prepared to provide complete documentation of active ingredients throughout the supply chain, going back to the starting materials that were used in the synthesis of the APIs. Read More
FDA’s Office of Manufacturing Quality will now be involved in evaluating all BLAs and supplements to ensure product quality throughout a product’s lifecycle. Read More
Observations cited in a Form 483 need to be carefully reviewed, because they represent — at least in the mind of that investigator — conditions that could make a drug adulterated. Read More
The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More