Archive for the ‘Imports’ Category
Monday, December 19th, 2011
The United States Pharmacopeia is placing supply chain security at the forefront with a new general chapter on best practices for ensuring supply chain integrity and protecting consumers from poor quality and counterfeit medicines.
USP General Chapter <1083>, Good Distribution Practices-Supply Chain Integrity, with the recently published USP General Chapter <1079>, ...
Posted in Bar Coding, Cold Chain, Counterfeiting, Diversion, Electronic Pedigrees, FDA, Handling, Hospital, Imports, Inspection, Internet, Outsourcing, Reimportation, RFID, Safety, security, serialization, standards, supply chain, Tampering, Theft, Transporation | No Comments »
Tuesday, July 12th, 2011
During a policy forum held today in Washington, DC, the Pew Health Group introduced its report, "After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs." Referring to the heparin-contamination case as a "wake-up call" to supply-chain risks, Allan Coukell, Pew's director of medical programs, said that while ...
Posted in Compliance Packaging, Counterfeiting, Diversion, FDA, Hospital, Imports, Inspection, Medical Devices, Medical Errors, Safety, security, serialization, standards, supply chain, Tampering, Theft | 1 Comment »
Friday, January 7th, 2011
I was asked for a legislative update on pharmaceutical quality and security efforts a while ago, so I searched thomas.gov and found the below. I thought I would share it because 2011 may bring some changes--although it is still early!
Of all the pharmaceutical related bills last year, these seem to ...
Posted in FDA, Imports, Quality, Safety | No Comments »
Tuesday, November 16th, 2010
Axendia has released the findings of its study on the global supply chain, and I wasn't at all surprised to see that what life science executives say they need is guidance from industry consortia (59%) and regulatory mandates (51%). "Our research shows that industry executives are relying less on internal ...
Posted in Counterfeiting, Diversion, Imports, Inspection, Outsourcing, Safety, supply chain | 1 Comment »
Tuesday, August 17th, 2010
We recently surveyed our readers in our annual salary survey, and many of them referred to the supply chain as a global one, like it or not. (Many, of course, are worried about losing jobs to other countries, but there may be some good news for them on that front.)
Fears ...
Posted in Electronic Pedigrees, Imports, Safety, security, supply chain | No Comments »
Thursday, March 11th, 2010
If you are wondering what FDA is thinking these days when it comes to drug safety, you should read yesterday's statement from Joshua M. Sharfstein, M.D., FDA's principal deputy commissioner, before the Committee on Energy and Commerce, Subcommittee on Health, U.S. House of Representatives. You may not have all your ...
Posted in Compliance Packaging, Counterfeiting, Diversion, FDA, Hospital, Imports, security, serialization, Third Parties | No Comments »
Monday, February 22nd, 2010
FDA is working to tighten U.S. borders when it comes to product safety. In February alone, import alerts for "Detention Without Physical Examination (DWPE)" have been issued for several medical device or drug-like items: unapproved new drugs, active pharmaceutical ingredients that appear to be misbranded, potentially defective medical gloves, devices ...
Posted in Imports | No Comments »
