Post-Heparin: Baxter Responds
Baxter International (Deerfield, IL) recalled thousands of vials of heparin in early 2008 after physicians in Baxter's pharmacovigilance
group detected an increase in reported adverse reactions associated with the blood thinner in the United States (1, 2). Baxter
and FDA later traced contamination (oversulfated chondroitin sulfate) to the product's active pharmaceutical ingredient (API),
which was supplied by Scientific Protein Laboratories' (Waunakee, WI) Changzhou, China, facility (3, 4). FDA performed an
inspection in February 2008, which resulted in an April 2008 warning letter to Changzhou SPL that noted significant deviations
from current good manufacturing practices of APIs (5). Pharmaceutical Technology talked to Baxter International's director of corporate communications, Erin M. Gardiner, about the event.
PharmTech:
What is Baxter's current take on the heparin incident?
Baxter:
The heparin contamination was an unusual, extraordinary event that exposed vulnerabilities in a very small portion of Baxter's
supply chain (as well as the other companies across the globe that experienced the same tampering) that we are aggressively
addressing.
PharmTech:
How much does Baxter source from China for its US products?
Baxter:
Less than 1% of all Baxter products sold in the US include components sourced from China. The manufacturing facilities Baxter
has in China produce products to be used in China and the Asia– Pacific market.
PharmTech:
What changes has Baxter made to its supply chain?
Baxter:
Broadly speaking, the heparin contamination crisis has reinforced the importance of staying focused long-term on supplier
quality improvements and confirmed the prudence of the Baxter initiative, which we launched well before the heparin issue.
The initiative includes enhancing our audit programs' frequency and duration, degree of scrutiny of new suppliers, and applying
the best technology we can to enhance our supplier quality controls. These efforts, aimed at our operations globally, include:
- A risk-based review of suppliers
- Additional tamper-proof measures
- Enhanced screening and testing technologies
- Mapping our supply chain to reduce the 'number of links in the chain'
- Increasing scrutiny of new suppliers
- A revamping our audit program, including improved training, duration, and frequency.
PharmTech:
What more can be done to ensure supply chains are safe?
Baxter:
Resting on old standards, even ones that have worked for decades, is no longer enough.... Improvements have been made in
the way we oversee our suppliers, the way we test, and how we anticipate the unimaginable. Baxter's name was on the product
[heparin] and regardless of how, why or where this [contamination] happened, it's our responsibility to learn from the experience
and take the appropriate actions to ensure this won't happen again.
References
1. Baxter Release, "Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ML 10 and 30mL Multi-Dose Vials,"
Jan. 25, 2008.
2. Baxter Release, "Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products," Feb. 28, 2008.
3. FDA, "Questions and Answers on Heparin Sodium Injection," updated July 16, 2008, available at
http://www.fda.gov/cder/drug/infopage/heparin/heparinQA.htm.
4. J. Woodcock, FDA CDER, "Statement before the House Subcommittee on Oversight and Investigations," Apr. 29, 2008.
5. HHS, "Warning Letter to Changzhou SPL Company, Ltd. from Richard L. Friedman, CDER," Apr. 21, 2008.
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