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ABOUT QUALITY & REGULATORY

Brenntag South Africa aims to drive excellence and compliance by ensuring the best quality ingredients and related services are available to the South African market.

Guided by our six core values, we embrace the requirements of quality management (ISO9001), pharmaceutical GxP (cGMP/GDP) and food safety (FSSC22000) standards. We are committed to continually improving our management systems, with a primary focus on meeting and exceeding the ever-evolving quality and regulatory expectations of our customers.

QUALITY ASSURANCE – WHAT WE DO

  • Continually improving, evolving and maintaining our ISO 9001:2015 and FSSC 22000 Management systems.
  • COA's are reviewed and approved by our Quality Assurance Officer prior to the order leaving the supplier to prevent delays with deliveries and ensuring our customer's expectations are met.
  • Supplier change notifications are shared with the customer timeously and effectively through our change notification system.
  • Customer complaints are resolved promptly and efficiently.

REGULATORY AFFAIRS – WHAT WE DO

  • Current and new supplier approvals are done in accordance with ISO 9001:2015 requirements to ensure high quality suppliers and materials to our customers.
  • Comprehensive regulatory support with Drug Master Files (DMFs), CEPs, Technical Agreements and Confidentiality Disclosure Agreements (CDA), for active pharmaceutical ingredients (API) and excipients for registration purposes.
  • Brenntag SA has the expertise to help customers to be compliant to South African Health Products Regulatory Authority (SAHPRA) regulations for both allopathic and complementary medicines.

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