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:
| US FDA | |||||
Ambernath – India |
Braine – Belgium |
Malmö – Sweden |
Strasbourg – France |
San Diego – USA |
Torrance – USA |
| 08 / 2016 | 08 / 2001 (Pre App.) | 10 / 1997 (Pre App.) | 09 / 2009 | 10 / 1992 | 03 / 1999 (Pre App.) |
| 11 / 2019 (Pre App.) | 12 / 2005 (Pre App.) | 05 / 2001 (Pre App.) | 05 / 2014 | 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 (Pre App.) | |||
| 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 | ||||
| 11 / 2021 | |||||
| WHO | Japan Ministry of Health and Welfare |
||||
Ambernath – India |
Braine – Belgium |
Malmö – Sweden |
Strasbourg – France |
San Diego – USA |
Torrance – USA |
| 02 / 2013 | 2001 | 2011 | 2011 | ||
| 02 / 2015 | 2005 | 2012 | 2016 | ||
| 05 / 2015 | 2009 | 2015 | |||
| 05 / 2017 | 2012 | 2016 | |||
| 04 / 2019 | 2013 | 2017 | |||
| 06 / 2019 | 2014 | 2018 | |||
| 06 /2022 | 2016 | 2019 | |||
| 2020 | |||||
| 2021 | |||||
| 2022 | |||||
| Swedish Medical Product Agency | Belgium FAMHP | Swedish Medical Product Agency | ANSM | USA, State of California |
|
Ambernath – India |
Braine – Belgium |
Malmö – Sweden |
Strasbourg – France |
San Diego – USA |
Torrance – USA |
| 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 / 2020 | 10 / 2012 | 12 / 2020 | |||
| 01 / 2022 | 11 / 2015 | ||||
| 04 / 2019 | |||||
| 03 / 2021 | |||||
| 09 / 2022 | |||||
| Ministry of Industry and Trade of The Russian Federation | |||||
Ambernath – India |
Braine – Belgium |
Malmö – Sweden |
Strasbourg – France |
San Diego – USA |
Torrance – USA |
| 08 / 2017 | 09 / 2017 | ||||
| Mexico´s COFEPRIS | |||||
Ambernath – India |
Braine – Belgium |
Malmö – Sweden |
Strasbourg – France |
San Diego – USA |
Torrance – USA |
| 02 / 2009 (Pre Appr.) | |||||
| China FDA (CFDA) | |||||
Ambernath – India |
Braine – Belgium |
Malmö – Sweden |
Strasbourg – France |
San Diego – USA |
Torrance – USA |
| 09 / 2015 | |||||
| Korean FDA | |||||
Ambernath – India |
Braine – Belgium |
Malmö – Sweden |
Strasbourg – France |
San Diego – USA |
Torrance – USA |
| 05 / 2014 | 11 / 2007 (Pre App.) | 05 / 2005 | 09 / 2005 | 10 / 2007 (Pre App.) | |
| 06 / 2012 (Pre App.) | |||||
| Health Canada | |||||
Ambernath – India |
Braine – Belgium |
Malmö – Sweden |
Strasbourg – France |
San Diego – USA |
Torrance – USA |
| 06 / 2023 | |||||