Quality & Safety

Our Quality – A Quick Summary

Quality

  • Numerous, redundant quality checks throughout the packaging process
  • 100% pharmacist check of all orders prior to shipment
  • All components QC tested and tracked
  • “Recall Advisement Service” for all manufacturer recalls of drug and component materials
  • Quality reporting, including a quarterly quality audit which may be utilized by customers for The Joint Commission inquiries.
  • Maintenance of a “Do Not Repackage” list to ensure compliance with all manufacturer labeling and FDA requirements
  • FDA and DEA registered
  • VAWD accredited by the National Association of Boards of Pharmacy

Safecor Health is registered with the FDA and DEA and achieves the highest standards of quality in the industry. All packaging processes follow proven policies, procedures and quality principles that ensure our products are correctly and accurately packaged and labeled. Substantial and redundant quality checks are documented throughout the packaging process and each production lot is monitored by a team of pharmacists who check 100% of all orders. Safecor Health invests in education for every employee and ensures, through competency assessments, that our staff perform processes according to prescribed operating procedures.

Safecor Health follows cGMP processes and controls, including written operating procedures, cleaning validations, storage and handling guidelines, maintenance of our facilities and equipment, expiration dating, and maintaining complete records for each production lot. Safecor Health uses only FDA-approved materials in packaging and processes those materials through quality controls upon receipt to ensure compliance with standards for each vendor. Our quality discipline is the primary reason why hundreds of pharmacies across the United States utilize Safecor Health as the Trusted Source for Repackaging.

Expiration Dating. Safecor Health strictly follows any FDA and manufacturer stability data and drug dating guidelines. Safecor Health also performs stability testing on packaging formats as necessary to ensure quality, safety and regulatory compliance.

Recall Notification Service. Safecor Health tracks each NDC and lot number for every medication that we repackage and will notify each applicable customer should a product be recalled by the manufacturer. In addition, customers can log on to Safecor Health’s online customer portal, “the Customer Center,” within our website to perform their own recall search.

Label and Bar Code Expertise. Safecor Health can help with the standardization of labels, bar codes and their content, and, in some cases, we also help with product standardization. We can print any commercially available bar code and embed lot number, expiration dates, and any other relevant data in each bar coded product. We work with you during the initial setup to establish the required label and bar code template for each type of packaging format. Our standard labels automatically include Tall Man lettering, and notations for hazardous and light-sensitive medications.

Standard label and bar code includes:

  • ISMP Tall Man lettering (and Custom Tall Man)
  • All commercially available bar codes
  • Facilitation of hospital system standardization
  • Label template approvals and pharmacist control