Warning Letter: Ranbaxy Cited for CGMPs Deviations - Pharmaceutical Technology

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Warning Letter: Ranbaxy Cited for CGMPs Deviations
Jun 29, 2006
By: Kaylynn Chiarello-Ebner
ePT--the Electronic Newsletter of Pharmaceutical Technology

ranbaxy On June 15, 2006, the US Food and Drug Evaluation's Center for Drug Evaluation and Research (Rockville, MD, www.fda.gov) issued a 7-page warning letter to Ranbaxy Laboratories (Himachal Pradesh, India, www.ranbaxy.com) for violations to US current good manufacturing practices (CGMPs).

Investigators found "significant deviations" to CGMP regulations during a Feb. 20-25 inspection of the company's pharmaceutical manufacturing facility in Paonta Sahib, India. Ranbaxy issued three responses (March 20, April 20, May 25) to the observations noted in an Inspectional Observations (FDA 483) form at the end of the inspection, but FDA still has several concerns:

  • Laboratory records did not include complete records of operating conditions and settings used for analysis or raw stability data acquired during drug product and lot testing (21 CFR 211.194[a][4]).
  • Ranbaxy did not establish and follow a written stability testing program to assess drug product stability and to determine storage conditions and expiration dates. Stability sample test intervals were undocumented (21 CFR 211.166[a][1]) and storage conditions were not adequately documented (21 CFR 211.166[a][2]).
  • The quality control unit does not have the personnel and the equipment to conduct proper drug stability testing (21 CFR 211.22.[b]).

FDA said in its letter, "Until FDA has confirmed correction of the deficiencies observed during the most recent inspection and compliance with CGMPs, this office will recommend withholding approval of any new applications listing your Paonta Sahib facility as the manufacturer of finished pharmaceutical drug products."

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About the Author

Kaylynn Chiarello-Ebner

Kaylynn Chiarello-Ebner is a former managing editor of Pharmaceutical Technology.

Articles by Kaylynn Chiarello-Ebner
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Source: ePT--the Electronic Newsletter of Pharmaceutical Technology, 6/29/2006
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