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U.S. generics firms looking to lower drug-development costs by contracting with Chinese drugmakers for active pharmaceutical ingredients (APIs) need to do so carefully, according to an industry expert, who warned that such partnerships are not always cost-effective.
GlaxoSmithKline (GSK) has halted distribution of its antidepressant Paxil CR and diabetes drug Avandamet because of ongoing concerns about the manufacturing quality of the products.
The key to adhering to a predicate rules-based system for GMP and using a risk-based approach for computer system compliance successfully is to understand how systems are being used as part of the entire process, understanding if and how your company is relying on the system and understanding the impact of the system, according to an industry expert.
The FDA and the Justice Department have halted the distribution of GlaxoSmithKline’s (GSK) antidepressant Paxil CR and diabetes drug Avandamet because of ongoing concerns about the manufacturing quality of the products.
Embattled vaccine-maker Chiron has received the go-ahead from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to operate its Liverpool plant for the first time since the manufacturing facility’s license was pulled five months ago.
The FDA has cited Florida-based Lex Pharmaceutical following an FDA inspection that revealed multiple manufacturing violations at the company’s Medley, Fla., plant.
The Good Automated Manufacturing Practice (GAMP) Forum announced it will release a GAMP good practice guide Feb. 18 that will provide comprehensive direction on meeting current 21 CFR Part 11 expectations for compliant erecords and esignatures, including requirements for record integrity, security and availability throughout the required retention period.
The fate of Chiron’s Liverpool, England, manufacturing facility will hinge on a series of upcoming inspections to be performed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), said Chiron President and CEO Howard Pien.
Drugmaker Lex Pharmaceutical has been issued a warning letter following an FDA inspection that revealed a slew of manufacturing violations at the company’s Medley, Fla., plant.
The FDA sent a warning letter to an Alabama dental device manufacturer after an agency investigator uncovered several significant quality system (QS) regulation violations.