The SFDA published its final guidance document – currently only available in Chinese - last week, just a month after making a draft version of the guidelines available to industry for a seven day consultation period.
As expected the document places most of the burden of responsibility for ensuring quality on pharmaceutical manufacturers, calling on them to audit suppliers using in-house QC departments and warning company execs not to disrupt or interfere with such activity.
The SFDA also sets out the role excipient makers should play in ensuring quality, calling on them to implement management systems, conduct audits of their raw materials suppliers and use standardised product lot numbers.
Excipient firms are also required to take a pro-active approach should raw materials sources change according to the SFDA, which said manufacturers “should take the initiative and carry out the appropriate assessments.”
SFDA spokesman Zhang Wei told the CRIEnglish.com website that the agency will set up a national database to monitor the production and application of all pharmaceutical excipients, as well as a credit reporting system for producers.
Publication of the document comes three months after the SFDA clamp down on Chinese firms alleged to have used gelatine waste from the leather industry rather than food-grade gelatine to produce pharmaceutical capsules.
According to a report by China’s state news organisation Xinhua a subsequent investigation by the SFDA revealed that as many as 250 Chinese manufacturers were using leather industry-derived gelatin – which contains high levels of chromium – and producing unsafe capsules, which prompted the development of the new regulations.
SFDA director Yin Li, director of the State Food and Drug Administration (SFDA), told the ChinaDaily website that: “The recent capsule scandal exposed loopholes in supervision. The new regulation aims to fill in the blanks."
Li added that the new rules will come into effect on February 1 next year.