Regulatory Affairs

Sandoz Chided for Poor Pest Control, Packaging

Unresolved investigations into bottling and packaging operations and insect problems have landed one of Sandoz’s U.S. facilities a Form 483. During an October inspection of Sandoz’s Broomfield, Colo., facility, investigators found spiders, centipedes and moths. Read More

MHRA Offers Roadmap for Reporting Drug Defects

The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More

Canada Finalizes GMP Rules for API Manufacturers

Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More