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FDA Warning Letter to Chinese API Firm Cites Cross-Contamination Concerns

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FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation

FDA’s growing experience with the field offices it has established in India, China and eight other countries is substantiating their benefit in boosting the agency’s efficiency and effectiveness in regulating a global supply chain....

International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making

The deepening channels of international information sharing are having an increasing impact on inspection decision-making and activities at FDA....

Industry/Regulator Forums Point to Role of Glass Suppliers in Injectable QbD

The complex issues around glass quality and drug product interactions bring into high relief the need for container suppliers to be directly involved in the implementation of quality by design (QbD) for injectables....

Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics

Breakage and particle problems associated with glass containers and biologic product sensitivities are prompting pharma firms to take a harder look at polymers for their vials and syringes....

FDA Micro Lab Data Concerns Continue with Warning Letter to Second Indian Firm

A warning letter to Ahmedabad, India-based Cadila Healthcare, issued by FDA’s drug compliance office in late June, is the second in as many months to cite an Indian sterile product manufacturer for recording air sampling plate counts that did not match what agency investigators observed during the inspection....

Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India

Evidence of unreliable laboratory data has prompted the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER) to issue warning letters over the past few months to drug manufacturers in China and India....

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....

Korea is Pressing Forward on CMC/GMP Harmonization Quest

Korea’s quest to more closely harmonize its CMC and GMP quality regulatory processes with ICH/global norms is creating openings for outside companies and regulators to work with the Korean FDA (KFDA) to resolve remaining differences.

FDA’s Focus On Lab Practices Abroad Continues in Four Recent API Warning Letters

Laboratory practices – a recurrent area of concern in FDA inspections abroad – again took center stage in a series of warning letters issued by the Center for Drug Evaluation and Research (CDER) compliance office to four foreign active pharmaceutical ingredient (API) manufacturers in December....
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