Pharmaceuticals and Life Sciences are verticals in which Grantek specializes in providing Automation Integration Solutions.
Our Subject Matter Experts and their teams focus on:
- Water Purification
- CIP/SIP Systems
- Batching Systems
- Turnkey Packaging Lines
- BAS/BMS/BAS Lite
- Clean Room Grade Hardware (Systec & Solutions)
In addition to the many challenges posed by maintaining GAMP-5 compliance, the Drug Quality and Security Act (passed by Congress on November 21, 2013) addresses 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 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.
Since the DQSA passage, Grantek has been helping clients prepare and comply with the Act, enabling Pharma manufacturers to meet the next phase, scheduled to begin Nov 21, 2017. This new phase 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 industries for over three decades, resulting in a deep understanding of its operations and regulatory requirements. We have experience automating Pharma manufacturing operations, including integration with business systems for a seamless solution to help meet the stringent requirements. We recognize the need in Pharma to move away from reliance on records gathered from discrete systems, which are difficult to maintain and may not provide the capabilities or information demanded to be compliant with today’s regulations.
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. We also provide thought leadership and consultative solutions to help our customers understand Smart Manufacturing, meet supply chain management issues and comply with strict regulatory requirements.