Almost all drug manufacturers make use of one or more contract manufacturers (CMO) and/or contract packagers (CPO) to package at least some of their products. One of the things drug manufacturers rely upon their contract organizations to provide them is the ability to comply with the labeling regulations of the markets they sell into. That means CMO/CPOs must keep their packaging capabilities current with the regulations in those target markets, or they may see a loss in business when regulations become more complex.
Serialization regulatory deadlines have either passed, or are approaching in four of the top five pharmaceutical markets in the world and more are established each year. Companies that offer packaging services to major drug manufacturers must develop and follow a program of adding multiple serialization-related capabilities to all of their pharma and biologic packaging lines within the next 18 months, or risk losing a significant percent of their business to competitors who already have. Drug manufacturers will have no choice but to move their business to vendors who are able to keep them in compliance.
Role of pharma contract manufacturers and packagers
CMOs and CPOs fill a vital role in the supply and quality of drugs in most markets around the world. That is because most NDA- and some ANDA-holders contract out the manufacture and packaging steps of an increasing percentage of their product portfolio. There are many reasons a company might do this:
- to meet peak demand;
- to balance uneven demand;
- to offload the production of older products so the primary manufacturer can concentrate internal resources on their latest blockbuster,
- to deal with complex manufacturing or packaging processes, and
- to supply smaller or remote markets.
And, by their very nature, virtual drug manufacturers use contract organizations to fill all of the manufacturing, packaging and distribution needs of their products.
By issuing a contract to a CMO or CPO, drug manufacturers offload many of the regulatory hurdles in the manufacturing and product labeling processes—particularly those related to current Good Manufacturing Practices (cGMP). Successful CMOs and GPOs market their services in a way that emphasizes their expertise at meeting cGMP regulatory requirements so that NDA- and ANDA- holders will have confidence that their products will not experience delays, cost overruns and brand tarnishment due to challenges from regulatory agencies.
That confidence is what brings in business. Lose the client’s confidence; lose the business to someone else who can uphold it.
CMOs and CPOs contribute to the safety and security of global pharmaceutical supply chains by adopting the technical capabilities to meet increasingly sophisticated regulations on behalf of their clients. Drug manufacturers rely on CMOs and CPOs to keep their packaging lines up-to-date with the regulations in the markets they serve.
CMO/CPOs and global pharma serialization and tracing regulations
In just the last few years, governments in most of the largest pharmaceutical markets in the world have enacted new regulations requiring drug makers to place unique serial numbers on their product packages and homogeneous cases, and communicate those numbers to either the government, a third-party, or to the buyer in the supply chain.
These regulations vary in a number of ways, but because these serial numbers must be placed on the product packaging, drug manufacturers who make use of contract manufacturers or packagers must rely on those companies to do most of this new work. Fortunately most of the new laws accommodate a similar approach to applying serial number on drug packages. Most allow the application of a GS1 Datamatrix barcode encoding the GS1 GTIN, serial number, expiration date and lot number. Some countries require an additional drug registration number.
In the past, drug packaging lines could use pre-printed labels that included the identifying barcode. Within a given batch, all data elements were static. Each package had the same data printed on it. Automatic quality inspection systems only had to confirm that the static barcode, lot number and expiration date printed on each package were readable.
But after the effective date of one of these new drug serialization laws, the drug packages targeted for that market must contain dynamic information. That is, information will be different on each package produced.
For example, after November 2017, all drugs packaged for the US market must contain a unique serial number in human readable and machine readable forms. That means the automatic quality inspection systems on these packaging lines must be capable of confirming not just the readability, but the validity and uniqueness of the serial number printed on each package in both human readable and barcode form. This is much more complex than the older systems needed to handle, thus necessitating a system upgrade to stay competitive.
Other markets will require capabilities that go beyond those in the United States. These include:
- Serial number randomization
- Request of serial numbers from an online government service
- Capture of the packaging hierarchy based on serial numbers (known as “aggregation”)
- Optional use of Radio Frequency Identification (RFID) tags in place of GS1 Datamatrix barcodes
- Transmission of serial number-based transaction data and aggregation data to a government repository, or to the next owner of the product in the supply chain
Considering the rankings of these markets, choosing not to upgrade these systems is not an option. NDA- and ANDA-holders will be forced to seek out and move their packaging business to contract packagers that have these capabilities and know how to use them as these deadlines approach. That is because the regulations make the NDA-/ANDA-holder liable for compliance, not the contract packager. To remain compliant, NDA- and ANDA-holders will have no choice but to move to contract packagers who project confidence that their client’s products will meet these new requirements.
Conclusion
As new drug serialization and tracing regulation deadlines approach in multiple major markets, companies who offer contract packaging services to global pharma manufacturers must begin upgrading all of their drug packaging lines to retain their existing customers. Companies who are ahead of others in the contract packaging industry may use this situation as an opportunity to significantly expand their client-base as slower competitors fail to upgrade in time or who fail to demonstrate expertise in meeting these new regulations.
(The author is Regulatory Strategist at Systech International)