Pharmaceutical Contract Packaging: Quality And Technologies

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