Issue Date: September 10, 2012 | Web Date: September 7, 2012
China Investigates Antibiotic Manufacturing Practices
China’s State Food & Drug Administration (SFDA) is investigating claims that several drug manufacturers have used cooking oil discarded by restaurants to produce antibiotics.
SFDA says it is “highly concerned” that antibiotic makers have made use of 7-aminocephalosporanic acid (7-ACA), a cephalosporin antibiotic intermediate, produced with the aid of an oily liquid waste collected from restaurant gutters instead of fresh soybean oil.
SFDA calls the practice “wrong” but adds that it is as yet unsure whether the use of gutter oil affects the quality of the resulting drugs. Soybean oil is added to antibiotic fermentation broths to increase yield of cephalosporin C, a 7-ACA precursor.
The use of out-of-specification raw materials violates current Good Manufacturing Practices (cGMP), says Peter Saxon, president of Saxon International Associates, a New Jersey-based consulting firm that has advised dozens of Indian and Chinese drug companies on meeting U.S. drug manufacturing regulations. cGMP is a set of standards that all companies supplying drugs to the U.S. must meet.
Saxon says he has encountered numerous firms in India and China that try to justify their use of substandard starting materials by saying that they do not affect the final product.
China is one of the world’s largest antibiotic suppliers. Qilu Pharmaceutical and Joincare Pharmaceutical, two companies alleged to have used gutter oil, issued statements denying the practice. Joincare says it has gone back to its sourcing invoices and verified that it has consistently purchased soybean oil. Qilu says it thoroughly audits the quality of all its raw materials.
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