DCGI in India to Review cGMP Compliance for Ranbaxy Facilities
August 7th, 2013 // 12:23 pm @ jmpickett
Latest FDA and cGMP Compliance News
The Drugs Controller General of India (DCGI) is going to review the cGMP compliance of all manufacturing plants for Ranbaxy Laboratories in India, after the recent serious cGMP problems for Ranbaxy. Ranbaxy was fined $500 million by FDA for manufacturing certain drugs that were not in adherence to cGMPs. The company also hid data and lied to FDA about the improperly manufactured drugs.
Meanwhile, Daiichi Sankyo, which acquired the company during the scandal, is trying to undo the damage done to Ranbay’s reputation. Since the end of 2011, Ranbaxy has not been able to export drugs from its Dewas plant in India. However, recent indications are that the new owners of Ranbaxy are hard at work trying to clean up the facility so that regular operations can begin.
According to a recent report, one of the first things that you notice in the plant is the adherence to hygiene and safety. There is now a very complex drill to enter the manufacturing facility. A turnstile that is access controlled regulates the entry into every room. Then you have to walk through a gush of moving air, which is known as an air bubble lock. This goes into an area that is sort of an anteroom, where you have to take off your shoes and clean your feet with water and soap. Then you dry them and put on slippers.
Now, you have to be covered from head to toe to stop contaminants from getting in. The unit has hand sanitizers everywhere as well as eye shower units to clean the eyes and hands. There also are cameras everywhere.
Much of this has been there for a few years, but the regulated entry and the cameras are all new.
Daiichi Sankyo claims that it has invested about $300 million in quality, equipment, training and infrastructure to correct the problems that included major cGMP violations and falsifying drug data.
The company also is reported to be using several third party consultants, some of whom are mandated by FDA. Some of the names include mercer, BCG, Quintiles and Lachman Consultants.
At the Dewas facility, the plant has physically separated the manufacturing blocks. Each has a separate point of entry, cameras, biometric ID cards and turnstile gates. This helps to regulate movement of staff and keep a constant eye on what is going on. The plant has a micro lab facility that is new and the QC lab has also been expanded.
In an attempt at transparency, every plant now has a bulletin board that shows key indices to keep an eye on quality, production, errors and deviations. Every three months, a QC review meeting takes place at the site, regional and global levels. If there are any serious signals, such as foreign material deviations, the issue gets to top management in one business day.
Ranbaxy also is obtaining new equipment and tools that will help to boost quality standards, and is putting in processes and automations that reduce manual intervention.
It installed automated external washers that help to clean out the containers for drugs to international global standards. It also has a new technology for package processing that does a 100% automatic inspection of every label and package.
The company also has started several new initiatives that process and archive data electronically, from R&D to manufacturing plants to clinical trials.
