Concerns Mount Over Data Integrity and Compliance Issues Abroad

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world. Over the past three years, as the FDA has increased inspections of offshore facilities, the agency has penalized a number of API manufacturers in India and China for cGMP violations, many of them involving data integrity. In some of the FDA inspection reports, quality control staffers said that they were ordered by superiors to back date lab data, or to delete information and perform tests until samples passed.  Some of the companies whose plants were penalized were also put on an import ban list, preventing them from shipping products to the United States. 
As more of these plant issues became public, rumors spread in India in February 2016 that the US was banning all imports of API from India and China (1). In fact, the ban only affects supplies that are covered by US government contract.  

The panic might be understandable, given the growing number of regulatory citations directed at offshore API facilities. Because India and China supply 80% of the APIs used in US pharmaceutical production, mostly commodity-type products, the US government has been questioning FDA’s ability to monitor quality in Chinese and Indian plants, according to a February 2016 report in the Regulatory Affairs Professionals Society (RAPS) journal, Regulatory Focus. API manufacturing company executives believe that data integrity issues and perceptions that offshore suppliers are not sufficiently trained in current good manufacuring practices (cGMPs) are driving a move back to outsourcing more APIs manufactured in the U.S. and Europe. 

According to the RAPS report (2), 41 manufacturing sites in China are now on import alert, five are on alert in Hong Kong, and 42 sites in India (some of which have only been cited for problems with specific products, not all of their manufacturing output). In December 2015, RAPS reported, US representatives wrote to the US Government Accountability Office asking that it look into whether FDA could handle the load of inspections now required in India and China. RAPS also pointed out logistical issues that FDA has faced in getting visas that would allow more of its new inspectors to work in China. The agency closed two Chinese offices in 2014 to consolidate activities in Beijing, according to RAPS.  In India, FDA plans to increase the number of inspectors from nine to 19, RAPS reports. Below are just a few of the offshore API manufacturing facilities involved and the penalties they received:

• A Dr. Reddy’s facility in India received a warning letter for documentation problems

• Zhejiang Hisung’s plant in China was cited for data manipulation 

• Ipca Labs’ three API plants in India were cited for data integrity problems.

References
1. D. Shenoy, “Misleading Reporting:  Indian Pharma Company APIs are NOT Banned in the U.S., “ CapitalMind.in, online.
2. Z. Brennan, “US FDA Inspections in China: An Analysis of Form 483s from 2015,” Regulatory Affairs Focus, Regulatory Affairs Professionals (RAPS) Society, www.raps.org.

Article DetailsPharmaceutical Technology
Vol. 40, No. 3
Pages: 26–29

Citation:
When referring to this article, please cite it as A. Shanley, “Concerns Mount Over Data Integrity and Compliance Issues Abroad," Pharmaceutical Technology 40 (3) 2016.

Editor’s Note:

Corrigendum: Reference to Biocon Limited

On March 02, 2016 in our Volume 40, issue 3 we had published a story titled “Concerns Mount Over Data Integrity and Compliance Issues Abroad” authored by Agnes Shanley.  In the said story we have erroneously reported that "Indian-based Biocon Ltd. was placed on an import ban list"

The averments in the said article that Biocon was placed on an import ban list are wrong and incorrect and have been published due to a proof reading error committed by the author of the said article. We hereby specifically state and clarify that we have no knowledge that product of Biocon Ltd. has been placed on an import ban list.  We sincerely regret the mistake made in the said article.