We strive to be at the cutting edge of serialization standardization, which is why I am honored to have my article published in one of the industry’s leading publications, Pharmaceutical Online.
Cookeville, TN (PRWEB) May 29, 2013
David A. Loy, the Senior Directory of Quality and Regulatory Affairs for Aphena Pharma Solutions, a pharmaceutical packaging industry leader, wrote an article that was recently featured on Pharmaceutical Online, discussing the strategy of standardizing drug serialization. Loy’s article discusses the need and process of a universal standard for pharmaceutical track and trace solutions as well as the importance of a secure and safe regulatory process.
The drug serialization topic continues to be largely discussed with the ever growing recurrence of drug counterfeits in the pharmaceutical supply chain.
Loy states, “This is a very important topic for our industry, something we have been following closely for years. At Aphena, our personnel, equipment and facilities are guided by exacting processes and procedures. Aphena’s facilities are FDA registered and DEA and State Board of Pharmacy licensed.” He continues, “We strive to be at the cutting edge of serialization standardization, which is why I am honored to have my article published in one of the industry’s leading publications, Pharmaceutical Online.”
The expectations from legislators, regulators and standards regarding track and trace of pharmaceutical products are being communicated to the industry; however, it is becoming evident that there are resource limitations in order to address these new expectations. In the article, Loy discusses focusing on the project piloting, implementation and time requirements to get these serialization systems up and running in a timely fashion.
Compliance is one of the most important factors. Any systems that are added or maintained to help resolve this serialization issue must follow all legal regulations that are in place.
In order to form the strategy, the right questions need to be addressed. A structure analysis must be applied to assure a comprehensive understanding of the processes and scope of the effort. An item list and timeline should be mapped out to ensure clear expectations of who will deliver what and when it will be delivered.
Loy reiterates the important of testing a process again and again. This type of standardization would be complex and involved; there is a lot of room for error that should be address before formal implementation. Errors in the process could cause significant compliance issues or largely raise unnecessary costs.
The need for internal corporate regulations for this process would be a necessity. In addition to all of the requirements needed for the regulatory purposes, the corporations will need additional internal requirements in place to clearly describe internal users’ expectations for the delivered system.
This article written by David A. Loy, Serialization Strategy 101, recently featured in Pharmaceutical Online, just scrapes the surface of the regulatory requirements and processes needed in place to implement such a standardized drug serialization process. The issue of counterfeit drugs in today’s pharmaceutical supply chain is a serious and timely matter which Aphena Pharma is not ignoring.
David A. has been involved in track-and-trace, pedigree and unit-level serialization since 2006. Loy developed, approved and implemented a fully traceable, unit-level serialization program that has produced over 25 million uniquely identified units. Loy maintains current Designated Representative status in both California and Florida and is well versed in the regulatory requirements and implications of existing and pending state and national legislation associated with track and trace, including serialization. Loy holds a MA and BA in English from Tennessee Technological University located in Cookeville, TN.
Published Article: http://www.pharmaceuticalonline.com/Doc/serialization-strategy-0001
About Aphena Pharma Solutions:
Aphena Pharma Solutions, Inc., specializes in providing quality, compliant pharmaceutical packaging and manufacturing services by exceeding customer expectations through strong teamwork, empowered employees and continuous improvement. Aphena was formed by a family of well-established, seasoned companies (PrePak Systems, TestPak, Celeste and Integrated Pharmaceutical Packaging). Several of these organizations have been in this industry for over 25 years. Aphena has five FDA-registered facilities in the U.S. and offers customers several capabilities. The products Aphena is actively handling include solid dose, liquids, gels, creams, ointments, foams, suspensions and lotions. http://www.AphenaPharma.com