cGMP and Audits
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2Y-Chem, Ltd.
- Add: No.10, Lane 1000, Zhangheng Road, China (Shanghai) Pilot Free Trade Zone
- Tel: 86-21-51320090
- Email: info@2ychem.com
- Web: www.2ychem.com
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2Y-Biopharma, Ltd.
- Add: Jiangfeng Road, High-Technology Industrial Development Zone, Qidong, Nantong, Jiangsu, China
- Tel: 86-0513-83266672-8001
- Fax: 86-0513-83266672-8005
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 |
NMPA Audits
Successfully passed NMPA (provincial offices) on-site audits for R&D activities supporting drug application in China.
- September, 2015
- December, 2014
- September, 2013
