Product/Service

Pharmaceutical Contract Packaging: Quality And Technologies

Ropack

Our cutting-edge technology and impeccable standards ensure that our customers receive products that meet their exact needs.

Quality
Our cutting-edge technology and impeccable standards ensure that our customers receive products that meet their exact needs.

Quality Systems

  • All procedures adhere to cGMPs
  • Training programs are in place and help enhance operators’ skills
  • QA-controlled documentation (SOP/Specification/MBR)
  • Change control system
  • Non-conformity, complaints and deviations are reported in system and trended
  • Quality documentation stored for six years in controlled archives

Quality Controls During Production

  • Checkweighers and other control/inspection devices are utilized throughout the packaging process
  • On-line inspection for all production performed by qualified personnel
  • Dedicated quality assurance/quality control personnel ensure strict cGMP compliance to SOPs and FDA regulations
  • Detailed batch record documentation accompanies every project
  • Non-compliant products and components stored in controlled access quarantine area
  • All instruments are calibrated

Accreditations

  • Food and Drug Administration (FDA)
  • Health Products and Food Branch (HPFB)
  • Establishment License for pharmaceutical products:
    • Manufacturing, packaging/labeling, importing and wholesaling
    • ISO 9001:2008
    • cGMP and HACCP compliant
    • Client audits: more than 100 pharmaceutical customers in U.S., Canada and the E.U.
    • Controlled substance license with level 9 vault security
    • Licensed for Class A precursor products
    • Licensed for natural health products
    • Organic certification
    • Approved facility for U.S. Military/NATICK and Canada DND

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