This the second and last part of the Serialization and Beyond webinar wrap-up. You can find the first part here.
Systech has been conducting educational webinars on important market issues for many years now. Much of this has centered on getting our customers the information they need to meet major pharmaceutical serialization requirement mandates in the United States (DSCSA) and the European Union (FMD). Now, with these mandates “live”, customers are looking at value beyond compliance in their serialization environments and investments.
Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.
First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings...
In late August, the China National Drug Administration (CNDA) posted three new draft guidance documents detailing a proposed National Drug Regulatory Information Standard and Traceability System. Chinese versions of the drafts are available now but the agency is requesting feedback from stakeholders and the public to be submitted by September 20, 2018. Final versions are likely to appear soon after that.
In 2017, the largest market for pharmaceuticals—the United States—delayed enforcement of their key pharma serialization requirement. The revised deadline for serialization and verification here is November 27, 2018, one year later than originally specified by Congress in the Drug Supply Chain Security Act. A few months before that delay was announced, Brazil withdrew their entire regulation, changed their law, and published a more reasonable timeline that would result in full serialization...
A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:
One of the often-forgotten facets of a pharmaceutical serialization project is the requirement to revalidate the packaging line and process during implementation. If companies need to purchase and implement new equipment to accommodate serialization, revalidation is expected. But, like many companies, if retrofitting of existing equipment takes place, validation may not be thought of early enough in the project. In either case, you may end up in a rush to write and execute several...
From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.
Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019. If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.