Quality Contract Packager & Distributor for North America
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