What the Pharmaceutical Industry Can Learn From Toyota's Recalls - Twelve lessons of what to do and what not to do to avoid quality problems. - BioPharm International

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What the Pharmaceutical Industry Can Learn From Toyota's Recalls
Twelve lessons of what to do and what not to do to avoid quality problems.


BioPharm International
Volume 23, Issue 7

REFERENCES

1. LaPonsie M. 2010 global Toyota recall. Autotechrepair.suite101.com. 2010 Feb 3 [cited 2010 April 3]. Available from: http://autotechrepair.suite101.com/article.cfm/2010-global-toyota-recall.

2. Maynard M. An apology from Toyota's leader. The New York Times. 2010 Feb 24 [cited 2010 April 3]. Available from: http://www.nytimes.com/2010/02/25/business/global/25toyota.html.

3. Woodyard C. Toyota CEO Akio Toyoda to House committee: Rapid growth to blame for safety lapses. USA Today. 2020 Feb 24 [cited 2010 April 3]. Available from: http://content.usatoday.com/communities/driveon/post/2010/02/my-name-is-on-every-car-ceo-akio-toyoda-will-say-toyota-grew-too-fast/1

4. Kubo N, Crawley J. Toyoda faces critical lawmakers over safety flaws. Reuters. 2010 Feb 24 [cited 2010 April 3]. Available from: http://www.reuters.com/assets/print?aid=USTRE61D2TS20100224

5. Deaths from runaway Toyotas put at 39 by investigators. ABC News /The Blotter from Brian Ross. 2010 Feb 24 [cited 3 April 2010]. Available from: http://abcnews.go.com/Blotter/RunawayToyotas/deaths-runaway-toyotas-put-39-investigators/story?id=9929661

6. Postmarketing reporting of adverse drug experiences, 21 CFR 314.80, and Postmarketing reporting of adverse experiences, 21 CFR 600.80.

7. Complaints continue after Toyotas are fixed. Associated Press (AP). 2010 March 4 [cited 3 April 2010]. Available from: http://abclocal.go.com/wabc/story?section=news/consumer/recalls&id=7309147

8. LaHood: Recalled Toyotas Not Safe. CBS News.com. 2010 Feb 24. [cited 3 April 2010]. Available from: http://www.cbsnews.com/stories/2010/02/24/business/main6238448.shtml

9. Enforcement policy-Firm-initiated recall, 21 CFR 7.46

10. US Food and Drug Administration. Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. Rockville, MD; 2004 Sept. [cited 3 April 2010]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf

11. Applications for FDA approval to market a new drug-Supplements and other changes to an approved application, 21 CFR 314.70.

12. Mitchell J, Searcey D. Toyota Accused of Withholding Records. The Wall Street Journal. 2010 Feb 27 [cited 3 April 2010]. Available from: http://online.wsj.com/article/SB10001424052748704625004575089803880464096.html

13. Postmarketing reporting of adverse drug experiences—Recordkeeping, 21 CFR 314.80(i).


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