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Meeting the Rigorous Regulatory Standards in Pharmaceutical Marketing and Labeling

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Abiding by the stringent quality control regulatory requirements for prescription drug and medical device labeling and promotional materials is paramount. Attention to detail is a must to keep your marketing materials aligned with approved content and quality standards.

Read “Beyond Print and Production: Streamlining Marketing Fulfillment for Your Pharmaceutical Sales Team” to find out how to meet rigorous government standards. You’ll gain an in-depth guide to creating and distributing prescribing information (PI), labels, and packaging that truthfully promotes your safety-critical medicines and devices.

Quality Control Measures You Can’t Ignore

Quality control measures help medical device and prescription drug manufacturers prepare marketing and labeling materials that are truthful and not misleading. These quality control requirements include:

  • Pharma and med device manufacturers and distributors are subject to federal and state regulations that govern how they advertise, promote and label products.
  • Marketing material production should follow print and production best practices, as outlined by Good Manufacturing Practices (GMP) and they should have G7 master printer certifications.
  • Proper documented marketing material inventory, warehousing and distribution processes should be followed to maintain compliance to ISO quality standards.
  • The Drug Supply Chain Security Act (DSCSA) has requirements that will need to be met no later than November 27, 2024, including that pharma products be validated at all points in the supply chain where custody changes. Compliance can be achieved with unique unit identification such as bar codes, QR codes or RFID.

The goal is clear: safe and effective use of medical devices and prescription drugs backed by accurate marketing and labeling materials. You need to partner with a printing and fulfillment service that can meet and exceed these criteria.

Download the Pharmaceutical Materials Fulfillment Whitepaper

Regulatory requirements work to promote quality products and clear and truthful marketing and labeling materials through the integration of review, inspection, surveillance, policy and research. Read “Beyond Print and Production: Streamlining Marketing Fulfillment for Your Pharmaceutical Sales Team” to explore how Resource Label Group can help you ensure you fulfill the necessary quality control requirements.

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