Tracking Quality in Drug Manufacturing video

October 28, 2013

Quality is crucial to ensure drug safety. A review of recent FDA enforcement reports and actions highlights issues relating to vial-filling, adequacy of quality assurance and quality control procedures, particulate matter in inhalation powders, and drug labeling.


Quality is crucial to ensure drug safety. A review of recent FDA enforcement reports and actions highlights issues relating to vial-filling, adequacy of quality assurance and quality control procedures, particulate matter in inhalation powders, and drug labeling.
AstraZeneca and Bristol-Myers Squibb have voluntarily recalled approximately 92,000 vials of their jointly marketed Type 2 diabetes treatment, Bydureon, in several European countries because some vials were not fully filled. The recall was issued after a review of manufacturing records indicated at least one of the batches may have had a very small number of under-filled vials, according to a September 16 alert distributed by the UK Medicines and Healthcare products Regulatory Agency.
No batches distributed in other markets were affected, and the companies don’t expect any supply issues. There is little evidence that patient safety would be compromised as a result of injecting an under-filled vial, and any health consequences would likely be minimum, according to Bristol-Myers Squibb.
FDA issued an import alert under which US officials may detain at the border drug products manufactured at Ranbaxy Laboratories’ facility in Mohali, India. The firm will remain on the import alert until the company complies with US cGMPs, according to a September 16 FDA statement.
FDA also ordered that the facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012. The decree contains provisions to ensure cGMP compliance and data-integrity issues at certain Ranbaxy facilities.
Boehringer Ingelheim, initiated a voluntary nationwide recall of certain lots of its Spiriva HandiHaler capsules due to the potential for extrinsic foreign particles in the API used to manufacture the product, according to FDA’s weekly enforcement report of September 25. The Class III recall, initiated on August 30, refers to products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.
In September, a federal judge approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs. Shamrock Medical repackaged and distributed solid and liquid oral nonsterile drug products for human use to hospitals throughout the United States. FDA reported that inspections found several violations at the facility, including failure by the quality control unit to fully follow its own QC procedures and to examine packaged and labeled products to ensure correct labeling.