cGMP and Audits

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  • Add: No.12, Lane 67, Libing Road, Zhangjiang Hi-Tech Park, Pudong, Shanghai China. 201203.
  • Tel: 86-21-51320090
  • Fax: 86-21-51320097
  • Email: [email protected]
  • Web: www.2ychem.com

cGMP
 

2Y-Chem is operated under cGMP according to ICH guidelines to provide our clients with clinical trial APIs and analytical services.

We have successfully passed cGMP audits from our clients, as well as third-party organizations.

We are listed by our multinational pharmaceutical customer as "Satisfactory" in Approved Supplier List (ASL) for Third Party Manufacturer (TPM) – API for Early Stage Clinical Development.

 

Examples of External Quality Audits 2010-2015.09  

 

Date  Organization  Status

September, 2015

PARAXEL (3rd party GMP audit)

Complete and accepted

December, 2014

US Customer, big pharma Complete and accepted
 August, 2013 Korean Customer, big pharma Complete and accepted
 June, 2012 US Customer, big pharma Qualified as supplier for API for early stage clinical development
 October, 2011 US Customer, big pharma Complete and accepted
 August , 2011 US Customer, big pharma Complete and accepted
 August, 2011  RFL Associates ( GMP consultant) Complete and accepted
 October, 2010 US Customer, Biotech Complete and accepted
 September, 2010 US Customer, Biotech Complete and accepted
 June, 2010 US Customer, big pharma Complete and accepted
 April, 2010  RFL Associates ( GMP consultant) Complete and accepted
 March, 2010 US Customer, Biotech  Complete and accepted

 

CFDA Audits 
 

Successfully passed CFDA (provincial offices) on-site audits for R&D activities supporting drug application in China.

  • September, 2015
  • December, 2014
  • September, 2013