EMA Deals with Manufacturing Deficiencies for Cancer Medicine - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Deals with Manufacturing Deficiencies for Cancer Medicine


ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals’ San Diego site. The deficiencies identified relate to adequate sterility assurance in the manufacturing process of DepoCyte. Production and batch release of the medicine are currently on hold, and new batches will only be manufactured once the deficiencies have been resolved and GMP compliancy confirmed by a reinspection.

According to a press release from EMA, there has been no evidence of any microbial contamination of DepoCyte on the market. The recall is being implemented as a precautionary measure in countries where suitable alternatives are available. For countries without therapeutic alternatives, DepoCyte will remain on the market, but with specific recommendations for monitoring patient safety and any signs of infection.

The inspection was conducted jointly by regulators from France and the UK at the DepoCyte manufacturing site in San Diego in July 2012. The EMA’s Committee for Medicinal Products for Human Use (CHMP) believes that the lack of sterility assurance poses a theoretical risk of sterility failure. Current data, however, have not suggested that there has been any Negative impact on the finished product.

DepoCyte is a prolonged release liposomal suspension for injection containing cytarabine for the intrathecal treatment of lymphomatous meningitis. The medicine was authorized in the EU in July 2001.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here