By Helena Champion, Drug Quality Assurance, LLC

Hope Is Not a Supplier Qualification Strategy!

People may hope that publicity and FDA warning letters about contaminated materials have caused suppliers to improve their supply chains to ensure quality, but events show this has not yet happened. People hope that suppliers based in the U.S. are reliable, but some U.S. brokers and distributors do not audit or adequately qualify their suppliers.

In 2008, more than 80 people in the U.S. and worldwide died from heparin contaminated with oversulfated chondroitin sulfate (OSCS), which costs a fraction of the ingredient usually used in heparin. Scientific Protein Laboratories in Changzhou, China, which is partially owned by Wisconsin-based Scientific Protein Laboratories, supplied some of the contaminated heparin.

Fast Forward to 2011

One would expect that Waunakee, WI-based Scientific Protein Laboratories (SPL) would have taken immediate corrective action. However, in a January 20, 2011 Warning Letter after a long 2010 inspection of SPL’s active pharmaceutical ingredient (API) manufacturing facility, the FDA stated that SPL did not conduct a formal investigation of potential OSCS in their heparin until 11 months after a 2008 complaint, did not extend the investigation to other lots of Heparin made using the same crude lot contaminated with OSCS until another eight months later, and only recalled three Heparin lots in October 2010, two years after receiving the complaint and only after the FDA inspection! SPL’s lack of quality oversight extended to other products — the FDA said SPL did not properly evaluate or audit the contract laboratory that reported passing results for pancreatin product after tests failed.

I recently audited a U.S.-based chemical supplier that advertises that it manufactures and distributes GMP-compliant pharmaceutical ingredients. The site I audited repackages chemicals and APIs sourced from brokers and suppliers whom they do not audit. This company “qualifies” brokers and suppliers by Self-Audit questionnaires and verification of Certificate of Analysis testing of some materials, but not all. The company does not have Quality Agreements or change control agreements with these suppliers, which may buy materials from different sources, depending on price and market conditions. This company puts its name and U.S. address on materials it supplies, but the materials could come from anywhere. A material could be from Synbiotics in Vadodara, India — the API manufacturer that refused admittance to FDA Inspectors in August 2010 (see FDA Warning Letter December 16, 2010). Or material could come from Glochem Industries Ltd in Visakhapatnam, India, which the European Medicines Agency declared had failed in GMP; Glochem threw more than 70 discarded batch records into the dump and replaced the records with new ones.

The point is, you would not know. The U.S. company I audited did not test a recently distributed batch of Glycerine (labeled USP) for the poisonous contaminant Diethylene Glycol, even though that test is required. The supplier did not perform the test either, yet they reported on the C of A that the material had passed the test.

FDA and European expectations for Supplier Qualification and Supply Chain verification are being emphasized more and more, for good reason.

Helena Champion, MS, MBA, is Principal Consultant at Drug Quality Assurance, LLC. She can be reached at drugqualityassurance@gmail.com.