Pharma/life sciences is one of the verticals where Grantek specializes in providing automation integration solutions. One of the challenges in this area, in addition to the many challenges posed by maintaining GAMP-5 compliance, is the Drug Quality and Security Act which was passed by Congress on November 21, 2013 to address weaknesses in the U.S. drug supply chain. Companies that fail to comply with the Act cannot sell product in the U.S.
The Act is actually comprised of Title I – Drug Compounding (Compounding Quality Act); and Title II – Drug Supply Chain Security (Drug Supply Chain Security Act). Initially, the Prescription Drug Marketing Act remained in force until January 1, 2015 at which time Phase I of the Act took effect, beginning a new era of traceability.
Grantek has been helping clients prepare and comply since it’s passage and is ready to help Pharma manufacturers meet the next phase, scheduled to begin Nov 21, 2017, which requires manufacturers to:
- Provide transaction information, history and transaction statements in electronic format
- Affix or imprint a product identifier to each package and case of product
- Verify at the package level, whether a suspect product is legitimate or not
- Respond within 24 hours to a request for verification
- Verify as legitimate returned products that are intended for resale
- Within two business days provide the transaction information, statement and history to a request by the Secretary or other federal or state official.
Grantek has worked in the pharmaceutical and life sciences industry for over three decades and has a deep understanding of its operations and regulatory requirements, through our experience with different manufacturers, and the regulatory environment in which pharmaceutical manufacturers operate. Globalization has increased the risk to patients and manufacturers from potentially dangerous, ineffective counterfeit medication. The Act provides a framework to verify medication and thus improves the security of the drug supply chain, reduces the potential for harm from illegitimate medication and helps track down the illegitimate sources.
Grantek has a long history of helping pharmaceutical/life sciences manufacturers automate their operations and that includes integration with business systems for a seamless solution that helps meet the requirements of the Act. Grantek works with customers to create systems that produce the serialized output for product tracking, and maintains the required historical records. We recognize the need for pharma manufacturers to move away from reliance on records gathered from discrete systems that are difficult to maintain and may not provide the capabilities or information demanded to be compliant with the Act. Grantek can develop a solution that allows required records to be created and compiled automatically, and integrated with corporate business systems.
Grantek uses smart manufacturing principles to design systems that can provide the backbone of serialization on pharmaceutical safety systems: traceability, absence of adulteration, label verification, and material management, according to the World Health Organization, 10% of all medicine sold worldwide is counterfeit. The requirements for serializing ingredients and even individual doses of medication dispensed at the pharmacy are tightening as governments seek to regulate the portions of the supply chain that are outside of the manufacturing facility.
In the pharmaceutical manufacturing industry, many integrators can deliver solutions that meet requirements, but Grantek also provides thought leadership to help our customers understand and meet smart manufacturing and supply chain management issues. We offer consultative solutions that allow creation of a business case for upgrading systems to meet stricter regulatory requirements.
Grantek contributes to standards development and we are the subject matter experts, not just the executors of a solution.