Aseptic Manufacturing Operation: Chinese Company Zhuhai United Laboratories does not comply with EU GMP

see   http://www.gmp-compliance.org/enews_04887_Aseptic-Manufacturing-Operation-Chinese-Company-Zhuhai-United-Laboratories-does-not-comply-with-EU-GMP_9345,S-WKS_n.html

While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are in the spot light. On 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories into EudraGMDP. Read more about the GMP deviations observed at Zhuhai United.

While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are again in the spot light. Just recently the EU found serious GMP deviations at an API manufacturer (Huzhou Sunflower Pharmaceuticals) and on 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories Co., LTD located at Sanzao Science &Technology Park, National Hi-Tech Zone, Zhuhai, Guangdong, 519040, China into EudraGMDP.

According to the report issued by the EU GMP Inspectors, Zhuhai United was not “operating its aseptic manufacture operations in compliance with EU GMP Annex 1. This was evident from the high number of observations regarding the aseptic manufacturing facilities design, equipment, operations, environment monitoring and media fill validation”. The internal quality system of the company did not detect the problems. As a consequence the GMP non-compliance report was issued in the EU database. Companies purchasing from Zhuhai United must change the API supplier. The CEP has been suspended.

However, the case also reveals a serious problem for patients in Europe. Due to the move of manufacturing sites mainly to Asia alternative sources may not always exist. In this specific case the EU GMP certificate was withdrawn by the GMP Inspectors but will be reissued to include only non-sterile products. A restricted GMP Certificate will be issued for sterile critical medicinal products for Romania, France, and UK.

Stakeholders in industry, authorities and in government in the EU need to discuss the problems caused by outsourcing and to the fact that products will sometimes only be manufactured by single sources in the necessary quantity. Once these suppliers do not comply with GMP, products are no available any longer, or by exceptions these non GMP compliant products may still be used in order to treat patients with medicines they urgently need. Both options are not acceptable from a patient point of view.

Map of Zhuhai United Laboratories Co.,Ltd.

  1. Zhuhai United Laboratories Co.,Ltd.

  2. Pharmaceutical Company
  3. Address: Yulin Rd, Jinwan, Zhuhai, Guangdong, China
  4. Phone:+86 756 776 6777

Yulin Rd, Jinwan, Zhuhai, Guangdong, China

Zhuhai Airport

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Author: DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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