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Janssen has moved to a continuous manufacturing process at one of its facilities after getting the green light April 8 from the FDA to switch from batch production, making it the first drugmaker allowed to change its production method mid-cycle. Read More
An FDA inspection uncovered a host of GMP deficiencies at a Wockhardt production plant in India, despite earlier attempts by the company to downplay the findings. Read More
Two domestic manufacturers and one in the territory of Puerto Rico have been called out by the FDA over inspection findings covering a diverse array of GMP concerns. Read More
The FDA has a slate of new recommendations companies should follow when submitting a comparability protocol assessing changes to the chemistry, manufacturing or controls of a drug or biologic after the agency has approved its production process. Read More
In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections. Read More
British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP certificate. Read More
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization. Read More
The fragmented nature of the modern manufacturing sector necessitates focusing less on technology and more on integration, according to an industry expert. Read More
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after apparently finding numerous GMP deficiencies. Read More