GMP Inspections

Regulatory requirements for peptide drug substances are unique and continually evolving. The PolyPeptide Group has the experience and the knowledge to assist and advise its customers through every step and change in the regulatory approval cycle.

PolyPeptide Group’s regulatory support includes preparation of all documents related to the drug substance required by the regulatory authorities. Regulatory support also includes assistance in meetings with regulatory agencies and, preparation of responses to questions from regulatory authorities in connection with the review of regulatory submissions.

The following Regulatory Agencies have inspected the PolyPeptide Group’s facilities globally:

Ambernath – India

Braine – Belgium

 Malmö – Sweden

Strasbourg – France

San Diego – USA

Torrance – USA

US FDA
08 / 2016 08 / 2001 (Pre App.) 10 / 1997 (Pre App.) 08 / 2009 (Pre App.) 10 / 1992 03 / 1999 (Pre App.)
11 / 2019 (Pre App.) 12 / 2005 (Pre App.) 05 / 2001 (Pre App.) 04 / 2014 (Pre App.) 01 / 1995 07 / 2001 (Pre App.)
06 / 2009 (Pre App.) 06 / 2004 (Pre App.) 09 / 2019 03 / 1998 09 / 2001 (Pre App.)
06 / 2012 (Pre App.) 09 / 2005 (Pre App.) 07 / 2004 11 / 2002 (Pre App.)
05 / 2014 09 / 2008 (Pre App.) 02 / 2005 12 / 2004
03 / 2017 10 / 2009 (Pre App.) 11 / 2005 01 / 2008
09 / 2013 08 / 2009 (Pre App.) 03 / 2009
05 / 2016 10-11 / 2009 01 / 2010
06 / 2010 07 / 2011
09 / 2011 02 / 2012 (Pre App.)
10 / 2012 04 / 2013
10 / 2015 11 / 2015
12 / 2017 (Pre App.) 07 / 2017
04 / 2019 08 / 2019
WHO Japan Ministry of Health and Welfare
02 / 2013 2001 2007 2011
02 / 2015 2005 2011 2016
05 / 2015 2009 2012
05 / 2017 2012 2015
04 / 2019 2013 2016
06 / 2019 2014 2017
2016 2018
Swedish Medical Product Agency Belgium FAMHP Swedish Medical Product Agency ANSM USA, State of California

11 / 2012 12 / 2008 05 / 2003 05 / 2006 09 / 1990 1997
03 / 2016 06 / 2011 01 / 2004 06 / 2010 05 / 2002
03 / 2019 03 & 10 / 2014 01 / 2007 06 / 2014
05 / 2017 01 / 2010 01 / 2017
10 / 2012
11 / 2015
04 / 2019
Ministry of Industry and Trade of The Russian Federation
08 / 2017 09 / 2017
Mexico´s COFEPRIS
02 / 2009 (Pre Appr.)
China FDA (CFDA)
09 / 2015
Korean FDA
05 / 2014 11 / 2007 (Pre App.) 05 / 2005 09 / 2005 10 / 2007 (Pre App.)
06 / 2012 (Pre App.)