Every
pharmaceutical company – whether it produces innovative brand-name,
generic or biologic drugs – must adhere to the same manufacturing
practices and strict quality control procedures necessary to manage a
complex, global network of suppliers and distributors. In addition to
complying with all government regulations, Teva has taken additional steps
to further strengthen our supply chain and promote safety, including voluntary
supplier audits. Teva’s manufacturing process specifically includes:
• FDA Approval
– Similar to the drug approval process, the FDA sets the highest
standards for the production and distribution of medications. These regulations
govern the sourcing, chemistry and manufacturing controls for each product,
and all Teva plants meet or exceed current Good Manufacturing Practices
(cGMP).
• Proven Partners
– In addition to relying on FDA inspection reports and cGMP certifications,
Teva also works with trusted suppliers and conducts onsite facility audits
to verify these vendors meet our exacting standards. We validate that
each manufacturing site has established proper controls for providing
consistently high-quality products.
• Rigorous Testing
– We physically inspect each shipment and perform analytic tests
using FDA methods to verify compliance with pre-established acceptance
specifications. We also retain a sample for future investigation, if necessary.
• Ongoing Monitoring & Reporting
– Once our drugs are on pharmacy shelves, Teva tracks patient reports
and monitors for trends. Our quality reporting system is designed to identify
any potential problems and evaluate if further action is warranted. We
also submit annual product reports to FDA.
|