Gap Analysis Critical for Combination Product cGMPs

To comply with FDA’s combination product good manufacturing practices, both devicemakers and drugmakers should first look at their systems and conduct a gap analysis using both the quality system regulation and drug cGMPs. Read More

Two Companies Fined in Defective Syringe Case

The UK’s Medicines and Healthcare products Regulatory Agency has successfully prosecuted two companies it says supplied defective prefilled syringes whose use resulted in a diabetic patient’s death in 2010. Read More

Expert Advice on Getting CAPA Right

Inadequate investigations and corrective and preventive actions have been one of the top reasons for 483 observations since 1997, says James Vesper, president of LearningPlus. A 30-year veteran in the lifesciences business, Vesper talked with FDAnews about how to develop a successful CAPA program to uncover root causes of quality failures. Read More