What role will automation play in QA in the future? Its role is vital. Weve 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
Products & Services
Quality Assurance and Compliance Software
Quality assurance and compliance software is used to test and inspect products and processes. These software packages are designed for activities such as compliance monitoring, project management, and product or system certification.
Biotechnology and Pharmaceutical Manufacturing Services
Biotechnology and pharmaceutical manufacturing services active pharmaceutical ingredients, sterilize biomedical components or materials, validate processes or packaging, and formulate drug or medicinal preparations on a contract basis.
Government Agencies and Laboratories
Government agencies and government laboratories provide standards, regulations, business statistics, research, funding and technical information. Examples include the FDA, FCC, OSHA, FTC, NSF, NTIS, NASA and USDA.
RFID Chips, or radio frequency identification chips use radio signals to transmit data over short distances. They are typically used for security, tracking and identification applications. RFID Chips can be paired with other circuitry to create a RFID tag or reader.
Product and Component Testing Services
Product and component testing services is the evaluation of a finished product or component through performance in electrical, life, environmental exposure, dynamic, ergonomic or other specialized tests. Also testing to standards such as UL 489, CE or MIL-STD 810.
Topics of Interest
In a remarkably short time, Ranbaxy Laboratories has become a force to reckon with in the pharmaceutical industry. Established in 1961, the company operated only in India until the early 1990s, when...
West spends a good deal of time educating contract manufacturers, through on-site seminars, on packaging science and technology. "The more they learn, the more they realize how little they know...
By Laura Osburnsen Director, Enterprise Security, Unisys Global Commercial Industries Counterfeiting continues to be a problem of crisis proportions for the healthcare and life sciences (HLS)...
Noting a dramatic increase in counterfeiting within the U.S., and more-sophisticated packaging and distribution channels, FDA has rolled out a new initiative designed to protect the public from...
By Paul Thomas, Managing Editor India is changing the global business and industrial landscape more than we can imagine, says Jim Pinto, renowned industrial analyst and self-proclaimed futurist. What...