Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline

Starting on Nov. 27, 2017, pharmaceutical manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code (product identifier), as stipulated by the Drug Supply Chain Security Act. (Editor’s note: On June 30, FDA issued new draft guidance pushing back the enforcement deadline for product identifiers to Nov. 27, 2018, though the compliance deadline remains Nov. 27, 2017.) Many drug makers have been preparing for this so-called “serialization” deadline for years by implementing new processes and systems in their internal operations, or by ensuring efficient transfer of serialization data from their contract manufacturing/packaging partners. However, some manufacturers — in particular, smaller or virtual firms — are now engaged in a mad scramble to meet all the requirements of the deadline.

Happy Independence Day!!!

Aseptic Enclosures team would like to wish our valued customers a happy 4th of July.

 

 

NECC and Future of Compounding Pharmacy

Compounding pharmacist’s case hinged on whether he was “willfully indifferent.

 

In 2012, a fungal meningitis outbreak killed more than 60 and left 732 people sickened. Many of those who survived face constant pain related to the illness. The cause of infection was large contaminated batches of injectable methylprednisolone acetate.

Achieving a Higher Standard of Practice for Sterile Compounding: What is your strategic direction?

 

Pharmacy co-founder blamed for meningitis outbreak that killed 76 gets 9 years in prison

 

The co-owner of a pharmacy responsible for the deaths of 76 people was sentenced Monday to nine years in prison after he tearfully apologized to victims who described watching their loved ones die or enduring excruciating physical pain from a 2012 nationwide fungal meningitis outbreak caused by contaminated steroids.

Alvogen Issues Voluntary Nationwide Recall

Alvogen Issues Voluntary Nationwide Recall of Clindamycin Injection Due to a Potential for a Lack of Sterility Assurance

Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.

Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects. Part 1 of this article provides an introduction to cleanroom microbiology, discussion of guidance documents and FDA observations, and a summary of common sources of microbial contamination in cleanrooms. Subsequent parts will address some cleanroom design basics, discussion of proper material transfer, aspects of cleanroom gowning, concepts of environmental monitoring, and the importance of disinfectant efficacy and proper cleaning.

Brown’s Compounding owner charged with selling unapproved drug

The owner and founder of a large compounding pharmacy that sold pain creams around the country and once employed more than 100 workers has been charged with introducing an unapproved drug into interstate commerce.

An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilit

Part of the Cleaning Validation for the 21st Century series

By Andrew Walsh; Ester Lovsin Barle, Ph.D.; Michel Crevoisier, Ph.D.; David G. Dolan, Ph.D.; Andreas Flueckiger, MD; Mohammad Ovais; Osamu Shirokizawa; and Kelly Waldron

Immediate Benefits Of Real-Time Microbial Monitoring

Companies producing medicines and biotech products are concerned with airborne microbial contamination. They need to ensure that products and people are kept safe. The traditional, accepted method to test for microorganisms at critical locations in a process is the use of Active Air Samplers or Settling Plates. Typically, 1-meter-cubed samples are taken onto agar plates and sent to a lab for culturing. The Colony Forming Units (CFUs) results come back from the lab after 4-10 days. Only after this waiting period will end users know whether the manufacturing environment was in control. Recently, the commercialization of a technology based on Laser Induced Fluorescence (LIF) has made it possible to look at airborne viable microbial counts in real time. The potential to instantly respond to an airborne microbiological event when it happens is exciting – and beneficial.