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 / 201608 / 2001 (Pre App.)10 / 1997 (Pre App.)08 / 2009 (Pre App.)10 / 199203 / 1999 (Pre App.)
11 / 2019 (Pre App.)12 / 2005 (Pre App.)05 / 2001 (Pre App.)04 / 2014 (Pre App.)01 / 199507 / 2001 (Pre App.)
06 / 2009 (Pre App.)06 / 2004 (Pre App.)09 / 201903 / 199809 / 2001 (Pre App.)
06 / 2012 (Pre App.)09 / 2005 (Pre App.)07 / 200411 / 2002 (Pre App.)
05 / 201409 / 2008 (Pre App.)02 / 200512 / 2004
03 / 201710 / 2009 (Pre App.)11 / 200501 / 2008
09 / 201308 / 2009 (Pre App.)03 / 2009
05 / 201610-11 / 200901 / 2010
06 / 201007 / 2011
09 / 201102 / 2012 (Pre App.)
10 / 201204 / 2013
10 / 201511 / 2015
12 / 2017 (Pre App.)07 / 2017
04 / 201908 / 2019
WHOJapan Ministry of Health and Welfare
02 / 2013200120072011
02 / 2015200520112016
05 / 201520092012
05 / 201720122015
04 / 201920132016
06 / 201920142017
20162018
Swedish Medical Product Agency Belgium FAMHPSwedish Medical Product Agency ANSMUSA, State of California

11 / 201212 / 200805 / 200305 / 200609 / 19901997
03 / 201606 / 201101 / 200406 / 201005 / 2002
03 / 201903 & 10 / 201401 / 200706 / 2014
05 / 201701 / 201001 / 2017
10 / 2012
11 / 2015
04 / 2019
Ministry of Industry and Trade of The Russian Federation
08 / 201709 / 2017
Mexico´s COFEPRIS
02 / 2009 (Pre Appr.)
China FDA (CFDA)
09 / 2015
Korean FDA
05 / 201411 / 2007 (Pre App.)05 / 200509 / 200510 / 2007 (Pre App.)
06 / 2012 (Pre App.)