Editorial: Implications of Serialization for the U.S. Pharma Industry

As published in Pharma's Almanac Q2 2017.

New requirements under the U.S. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. Some of these requirements began in 2014; additional requirements will be phased in until 2023. The next deadline — November 2017 — applies to manufacturers. Compliance is challenging, but noncompliance carries the risk of significant consequences. In addition, challenges won’t end with implementation: there will be vast quantities of data to manage to support serialized production moving forward.

Topics: Regulatory Compliance Serialization Supply Chain Editorials

Alcami Awarded for 2016 Manufacturing and Laboratories Operations Performance

Alcami was awarded by the North Carolina Department of Labor for our 2016 manufacturing and laboratories operations performance. Cherie Berry, North Carolina Department of Labor Commissioner, delivered the awards to members of the safety team. The following awards were presented:

Topics: News & Events


Name: Rebecca Forster
Alcami Site: Charleston, SC

How long have you been with Alcami?
I have been with Alcami for 2 ½ years.

What is your role?
I am the team lead for the Microbiology Department at the Alcami Charleston, SC facility.

Our team is responsible for microbiological monitoring of the environment that is involved in the manufacturing of parenteral drugs. The team also tests the product, performs utility testing, personnel monitoring and aseptic gowning training, sterilization cycle validation support, media fill support, and method suitability testing (just to name a few!) for added assurance that the product is sterile. 

What is the most rewarding part of your job?
Microbiology testing lies at the very heart of parenteral manufacturing. Knowing that what I do helps patients have a safe and effective product that has potential to save and/or change the quality of their lives is incredibly rewarding. There are not a lot of careers that offer the ability to have that type of impact.  Solving challenges such as leading investigations, as well as working on continuous improvement, is always a welcomed part of my day.

Topics: Blogs

Alcami Partners with Wisconsin Department of Natural Resources to Rebuild Kettle Moraine State Forest Trail

Germantown, WI (USA) – June 13, 2017 – Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announced a partnership with the Wisconsin Department of Natural Resources (DNR) to rebuild a half-mile section of the Pike Lake Hiking Trail in the nearby Kettle Moraine State Forest.

Topics: News & Events

In-Use Stability Testing: Providing the Right Instructions

In the WHO Technical Report Series, No. 953, 2009 Annex 2 Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products section 2.2.10, In-use Stability Testing is defined as:

“The purpose of in-use stability testing is to provide information for the labelling on the preparation, storage conditions and utilization period of multi-dose products after opening, reconstitution or dilution of a solution, e.g. an antibiotic injection supplied as a powder for reconstitution.” 

Like many guidance statements, it appears simple enough to understand, but then reality sets in.  How can a laboratory study be designed to execute potential real world uses of a product for a hospital or clinic?  How many lots of product are needed to meet expectations of the regulatory authorities?  Which batch(es) should be used in the in-use stability testing studies?  What analytical testing should be performed and at what time points should the testing be performed? 

Topics: Stability Blogs