Excipient Control Strategies in China - Pharmaceutical Technology

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Excipient Control Strategies in China
As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.


Pharmaceutical Technology



Officials visit drug-manufacturing facilities
The seven-person SFDA delegation and its hosts from the US Department of Commerce toured three US ingredient-production facilities at the invitation of IPEC-Americas members. On April 9, the group toured Colorcon's "Opadry" manufacturing facility in West Point, Pennsylvania, and saw FMC's "Avicel" manufacturing facility in Newark, Delaware. On the next day, the group visited Johnson & Johnson's Wilmington, Delaware, plant, which produces APIs for the company's finished drugs (see sidebar, "Officials visit drug-manufacturing facilities").

These productive visits helped establish a good working dialogue between SFDA, the Department of Commerce, and the US pharmaceutical and excipients industry. The SFDA representatives were impressed with the level of GMP controls in place at the abovementioned companies. They planned to use the information they gained to modify the excipient and API control strategies they will implement in China.

Recent events affect SFDA's improvement plans

Since the April meetings, several international events have highlighted concerns about the quality and safety of excipients and other food ingredients and products sourced from China. More than 100 people died in Panama after taking drugs that were contaminated with Chinese-produced glycerin that was adulterated with diethylene glycol, a poisonous chemical used primarily to manufacture antifreeze. Chinese-produced toothpaste that contained diethylene glycol was found in various US locations. Many pets in the US died from Chinese-sourced pet food ingredients that had been contaminated with melamine. Various other quality problems involving Chinese products have surfaced and received much media coverage. In addition, several high-profile corruption charges have been made against former SFDA officials. Some charges resulted in the imposition of the death penalty.

These events have put tremendous pressure on the Chinese government and SFDA to immediately eliminate corruption and strengthen regulatory controls of the manufacture of food and drug products, including excipients and food additives. SFDA has taken several measures to exercise oversight, but the magnitude of the problems will require much of the agency's resources in the coming months. It is uncertain how these problems will affect the timing of SFDA's planned revisions to its excipient regulations and SFDA's desire for flexibility in harmonizing regulations with international agencies.

IPEC's future

IPEC will continue to work closely with SFDA to help the agency improve its excipient-control systems and establish a sound approach to maintaining excipient safety and quality for products produced in China for the domestic and international markets.

SFDA has invited IPEC to participate in an upcoming SFDA internal training program in October 2007. IPEC will provide training to SFDA inspectors and reviewers regarding international excipient-control strategies, excipient GMPs, and DMF systems. IPEC will provide a full-day seminar for SFDA personnel on Oct. 29, 2007.

IPEC hopes to announce the formation of an IPEC Excipient Working Group in China at the SFDA training session. The working group would act as a focal point for collaboration on excipient issues between SFDA and the domestic and international excipient and pharmaceutical industries.

IPEC Americas is also helping the US Food and Drug Administration establish improved excipient-control systems for the importation of excipients from China and other countries. FDA formed a task force in response to the recent tragic events and is trying to determine the best approach to prevent these tragedies from occurring again. FDA asked IPEC Americas for assistance because IPEC has drafted many excipient-control guidelines such as the IPEC–Pharmaceutical Quality Group Excipient GMP and Auditing Guidelines, the IPEC Good Distribution Practices Guideline, the IPEC Americas Certificate of Analysis Guideline, and the IPEC Americas Significant Change Guideline for Bulk Pharmaceutical Excipients.

IPEC Americas' latest effort is the development of an Overall Excipient Qualification Guideline that outlines a process for qualifying the entire excipient supply chain from the manufacturer to the user. This guideline reflects the international concern about excipient safety. IPEC Americas plans to launch the first phase of this guideline at its Regulatory Affairs Conference on Sept. 10–11, 2007.


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