Ranbaxy’s Designs on Quality

What role will automation play in QA in the future? Its role is vital. We’ve already installed Documentum (EMC Corp., Pleasanton, Calif.) automated document management systems as well as instrument networking systems to enhance productivity and reliability, and plan to move to paperless laboratories, using e-notebooks, in the future. Our laboratories are already equipped with state-of-the-artinstruments for accuracy and precision measurements. Given the growing drug counterfeiting threat, how is Ranbaxy ensuring the safety of its products and its raw materials? There is no single “magic bullet” against the growing number of sophisticated pharmaceutical counterfeiters. Anti-counterfeiting is a global battle that industries and regulators simply must win. Track and trace technologies such as radiofrequency identification (RFID) are important, as is the development of e-pedigrees, but so are security technologies such as color-shifting inks, holograms and chemical markers. We use RFID technology in the U.S., but we also use bar codes, and we are using Alu-Alu packaging, the machinery for which is costly, and beyond the means of counterfeiters. However, these security measures areexpensive and might increase the price of some medicines. It will be interesting to see how various regions respond. As far as APIs and raw materials are concerned, we test and identify each and every container before it is released for production, to ensure that it meets our quality standards. Dealing with differences between global regulations must be difficult today. What are the biggest differences between the way that the U.S., Japan and Europe handle drug regulation today, and how does that affect quality operations? By and large, the regulations are the same for cGMPs in all three regions, but some differences that have an impact on QA strategy and operations are: Do you see the harmonization of international pharmaceutical regulations becoming a reality during our lifetimes? Or is it