Process for Pharmaceutical Label Manufacturing
APR 19, 2017

Our Process for Ethical RX and Consumer Healthcare Applications

Gintzler International guarantees innovation, quality, flexibility and accuracy in all that we produce. Our New York production facility is certified to ISO 13485:2003 and 9001:2008 standard guidelines to meet the stringent quality and service requirements of the medical and pharmaceutical industries.  Following is our process for ethical RX and consumer healthcare applications:

  • Needs Analysis – Identify the project to determine the optimal packaging solution, customized to meet the needs of the client and consumer while adhering to regulatory requirements.
  • Concept Evaluation – Conduct feasibility study; initial testing; and review of materials that are compliant to ISO, FDA, REACH and other applicable regulations. Considerations are given to:
    • Security solutions
    • Functional and complex performance of product
    • Innovative applications
  • Pre-Production Planning– Establish timelines and ensure milestones are achieved.
    • Samples and prototypes are reviewed.
    • Initial production methodology is established.
    • QC lab testing is performed to validate recommended solution.
    • Critical client requirements are linked to the product record within the ERP system.
  • Proofing– Create proofs to ensure the accuracy of the label and packaging. Process may include:
    • Ink drawdowns
    • 3D modeling
    • Production press proofing
  • Pre-Production Approval – Validate the product and application. Production samples may be provided for client testing.
  • Customized Production– Manufacture product in accordance with ISO 13485 standards.  This includes:
    • Security controls best suited for the needs of the individual customer
    • 100% inline text verification when needed
    • Finished rolls with leaders and trailers as required
    • Full chain-of-custody within a secure production facility
  • Documentation– Document controls for complete product traceability in line with cGMPs:
    • Full raw material and shipment chain-of-custody
    • First piece sign-off by internal PCM
    • Certificate of Compliance supplied with each shipment
    • Final QC inspection and approval
    • Product record finalized within ERP system

 Email today to discuss how we may assist you in achieving your packaging goals in relation to brand protection and chain-of-custody initiatives.

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