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CMC/GMP Procedures and Interpretations Can Pose Challenges For Foreign Firms in ICH Member Japan

While ICH has had a strong harmonizing influence on Japan’s CMC review process, outside pharmaceutical firms continue to wrestle with understanding and implementing the interpretations and expectations around timeframes, formatting, level of detail and procedural requirements for licensing products in Japan....

ASEAN Effort Progressing on CMC/GMP Harmonization, But Differences Remain

An analysis of the CMC/GMP regulatory framework among the Association of South East Asian Nations (ASEAN) shows significant progress in moving toward a more cohesive and harmonized approach, although differences remain in individual country requirements and procedures....

Mold Contamination in Claris IV Bags Results in Class I Recalls, Warning Letter and Import Alert

The findings of fungal contamination in IV bags contract-manufactured at Claris Lifesciences’ Ahmedabad, India facility has resulted in a three-product Class I recall, an FDA warning letter and a U.S. import alert on Claris products....

China’s Quality Regulatory Process Evolving Toward the Western Model

China’s quality regulatory process is evolving toward the Western model as it draws on and incorporates guidance from the EMA, WHO, FDA and ICH....

Japan’s Foreign Inspections Reveal Communication Chain Gaps

Foreign inspections by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are revealing gaps in the communication chain between marketing authorization holders in Japan, their overseas suppliers and the Japanese caretakers of the supplier’s master files, PMDA’s Liaison Officer with EMA Yoshikazu Hayashi reported at the annual meeting of the Active Pharmaceutical Ingredient Council (APIC) in Barcelona, Spain in late October....

Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe....

China’s SFDA Moving Toward Expanding Supply Chain Auditing and Filing Requirements

China’s State Food and Drug Administration (SFDA) has released a draft of a new regulation that would significantly expand the supply chain auditing and filing requirements for manufacturers of active pharmaceutical ingredients (APIs) and packaging as well as drug products....

Warning Letters to Two Overseas Sterile Ophthalmic Manufacturers Cite Similar Microbial Control Practices

FDA has issued warning letters to two foreign-based aseptic ophthalmic firms citing a strikingly similar litany of problems with procedures and practices designed to prevent microbial contamination....

India Strengthening its Central Regulatory Authority to Keep Pace with Industry Expansion

India is working to strengthen its central drug regulatory authority and related laws and regulations in response to its rapidly expanding domestic industry and the need for more interaction with foreign regulatory counterparts....

Potential GMP Trouble Spots at India’s API Firms Include Equipment Handling, CAPA, Documentation, and Training, India Auditing Expert Finds

Potential GMP concerns among India’s expanding number of API suppliers include equipment handling, CAPA, documentation and training, Semler Research Center COO/Director Gurudatta Gayatri reported at the DIA Annual Meeting in June....
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