The defects of Chinese products have been well publicized, but as far as drugs go, something remarkably scary has just happened.

Methotrexate, an anticancer medication, has reportedly been contaminated at the hands of Shanghai Pharmaceutical, which is the city’s largest pharmaceutical manufacturer.

While no evidence has surfaced that the drug was exported, The Wall Street Journal rightly notes that “the case provides a cautionary tale as Western pharmaceutical companies start outsourcing some manufacturing to China.”

It certainly is.

BizCult contacted ShanghaBio Corp., which works on drug development, to ask how foreign pharmaceutical companies can ensure quality of drugs or drug components developed in China. Shi Yao Zhou, director of business development, provided some hints on how to avoid chemical snafus that may have occurred at Shanghai Pharma.

Mr. Zhou’s experience is with keeping laboratories safe with Good Laboratory Practices (GLP), which are internationally recognized rules guiding non-clinical studies. Once drugs go up the development chain, Good Manufacturing Practices (GMP) should take effect. While he’ll speak on GLP here, surely the same lessons learned can be applied similarly to GMP, and in other industries as well.

So, if you have outsourced lab work to China, make sure your laboratory here is abiding by GLP, if your research requires it. For instance, ShanghaiBio gives clients the option of choosing GLP or non-GLP methods for study purposes, the non-GLP method being cheaper. Price always increases when the quality assurance is important, Mr. Zhou noted.

“If a project is clinical research or clinical-trial related, it has to be under the GLP system,” Mr. Shi said. “But if the project is a pilot or involves basic research, [they sometimes] don’t want to use the GLP system. If they are looking for some very rough data, or just want to look for suitable animals for testing, they may ask for non-GLP.”

Items not included in the cheaper, non-GLP service, involve data about instrument maintenance or quality assurance reports, Dr. Zhou said.

If a company applies strict GLP, Mr. Zhou said it would be hard for the Shanghai Pharma situation to occur.

But when asked whether ShanghaiBio competitors that offer lower prices might not adhere to GLP, Mr. Zhou said, “Maybe they will not comply with GLP or strict quality.”

Asked if he believes his clients sometimes choose the wrong service, Dr. Zhou replied, “It will happen, but not very often since our client is an industry client so they know what GLP means.”

Second, you can ensure your Chinese partner is abiding by GLP by performing a laboratory audit.

Finally, it’s possible that the Chinese drug company you hire to perform R&D would abide by GLP guidelines, but a third party that company has contracted with would not.

If, ShanghaiBio used a third party, Mr. Zhou said it would be his company’s responsibility to do a laboratory audit to ensure strict quality.

However, he suggested that foreign companies should check whether the third party has been audited, and he even went a step further:

“From my point of view, in the contract with the client, it should state that if there is outsource work to another company, then it should be audited by the western client,” Dr. Shi said.

Trust, but audit, seems to be the message.

    Channel: Vital News     |