Regulatory Services

Vendor Audit on GMP Compliance in China

Entrusted by foreign customers, we provide audit services for pharmaceutical factories in China on GMP compliance according to rules of cGMP, ICH Q7A, TGA, WHO-GMP and other guidance, and provide high quality audit reports in English to customers.

Successful Cases

Entrusted by Helm AG of Germany, GNI (Gene Networks International) of Japan and TARESH LTD of the UK etc., we have succeeded in auditing the following API manufacturers according to the ICH Q7A regulations and other international GMP rules.

  • Jiangxi Dongfeng Pharmaceutical Co., Ltd. (Jiangxi Dongfeng Pharmaceutical Factory)
    - FDA approved, Benzylpenicillin Procaine (Sterile) was audited.
  • Jiangsu Lianhuan Pharmaceutical Co., Ltd. (Yangzhou Pharmaceutical Factory)
    - Doxycycline hyclate and oxytetracycline HCl, FDA approved.
  • Zhejiang Second Pharamceutical Co., Ltd.
    - Sulfamethazine FDA approved.
  • Xinjiang Heshuo Ephedrine Product Co., Ltd.
    - Two CEPs of EPHEDRINE HCl and PSEUDOEPHEDRINE HCl issued.
  • Beijing Continent Pharmaceutical Co., Ltd.
    - GMP Technical Assessment for establishment of a Sino-Japanese Joint Venture.
  • Shanghai Asia Pioneer Pharmaceutical Co. Fourth Pharmaceutical Factory
    - Vendor audit for product purchase, dihydrostreptomycin sulphate, kanamycin sulphate and gentamicin sulphate FDA approved.
  • Hebei Huari Pharmaceutical Co., Ltd.
    - Two CEPs of its product issued;
    - Benzylpenicillin Procaine (Sterile) was audited.
  • Fujian Fukang Pharmaceutical Co., Ltd.
    - FDA approved, CEPs of chlorotetracycline HCl issued.
  • Shouguang Fukang Pharmaceutical Co., Ltd.
    - CEPs of Trimethoprim (TMP) issued.
  • Southwest Synthetic Pharmaceutical Co., Ltd.
    - FDA approved, CEP of Sulfadiazine issued.
  • Shijiazhuang Huashu Pharmaceutical Co., Ltd.
    - CEP of oxytetracycline base issued.
  • Jiangsu Dafeng Huashu Pharmaceutical Co., Ltd.
    - CEP of oxytetracycline HCl issued.