GMPs

APIC Advises API Distributors on Good Distribution Practices

Distributors of active pharmaceutical ingredients in Europe should build quality management systems that include the same features as drugmakers’ QMS in areas such as contamination control and documentation, according to a new reference guide on good distribution practices. Read More

FDA Warns Sun Pharma Over Deleting Trial Data

Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More

Health Canada Suspends Biolyse’s Establishment License

Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems. Read More