Regulatory Inspection History
Discover BioPharma Service’s flawless Regulatory Inspection History
Drug development is a highly regulated industry that is governed by the international quality standards of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). BioPharma Services has an unwavering commitment to quality and safety standards and steadfastly adheres to the principles set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
We have a long history of regulatory inspections dating back to 2009 with inspections by the US FDA & Health Canada, European agencies (UK MHRA, French ANSM, Danish DKMA, Dutch CBG & Austrian AGES), ANVISA and the World Health Organization. We also hold GLP certification by the SCC.
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| October 2022 | Toronto | GCP Inspection (Lab) | Zero Form 483 issued |
| October 2022 | St. Louis MO | GCP Inspection (Clinic) | Zero Form 483 Issued |
| May 2022 | Toronto | GCP Inspection (Clinic) | Zero Form 483 issued |
| August 2019 | Toronto | GCP Inspection (Lab) | Zero Form 483 issued |
| July 2019 | Columbia MO | GCP Inspection (Clinic) | Zero Form 483 issued |
| August 2018 | Toronto | Pre-approval Inspection (Clinic) | Zero Form 483 issued |
| August 2017 | Toronto | Pre-approval Inspection (Clinic) | Zero Form 483 issued |
| May 2017 | Toronto | GCP Inspection (Lab) | Zero Form 483 issued |
| May 2017 | Columbia MO | GCP Inspection (Lab) | Zero Form 483 issued |
| May 2017 | Columbia MO | GCP Inspection (Lab) | Zero Form 483 issued |
| December 2015 | Toronto | GCP Inspection (Clinic & Bioanalytical Lab) | Zero Form 483 issued |
| November 2015 | Columbia MO | Pre-approval Inspection (Clinic) | Zero Form 483 issued |
| November 2015 | Toronto | GCP Inspection (Clinic & Bioanalytical Lab) | Zero Form 483 issued |
| June 2015 | Toronto | GCP Inspection (Clinic & Bioanalytical Lab) | Zero Form 483 issued |
| August 2012 | Toronto | GCP Inspection (Clinic) | Zero Form 483 issued |
| March 2009 | Toronto | GCP Inspection (Clinic) | Zero Form 483 issued |
| February 2008 | Toronto | Pre-approval Inspection (Clinic) | Form 483 & BPSI Response Letter issued |
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| September 2022 | Toronto | Clinic/Bioanalytical Inspection (Observer: EMA / AGES Inspection) | Successful completion of GCP Inspection |
| January 2018 | Toronto | GCP Inspection (Clinic) | Successful Inspection, minor comments |
| May 2017 | Toronto | Controlled Substances Inspection | Successful Inspection, minor comments |
| March 2009 | Toronto | Follow up on Good Clinical Practice (GCP) Inspection | Zero Observations |
| November 2008 | Toronto | GCP Inspection (Clinic) | Inspection Report - BPSI Response Letter Issued |
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| April 2017 | Toronto | Inspection of bioequivalence trials for marketing authorization (Clinic & Bioanalytical Lab) | Successful completion of GCP Inspection |
Austrian Agency for Health and Food Safety (AGES)
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| September 2022 | Toronto | Clinic/Bioanalytical Inspection (Lead Inspectors) | Successful completion of GCP Inspection |
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| September 2022 | Toronto | Clinic/Bioanalytical Inspection (Co- Inspector) | Successful completion of GCP Inspection |
| April 2017 | Toronto | Inspection of bioequivalence trials for marketing authorization (Clinic & Bioanalytical Lab) | Successful completion of GCP Inspection |
Dutch Medicines Evaluation Board (CBG)
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| September 2022 | Toronto | Clinic/Bioanalytical Inspection (Co- Inspector) | Successful completion of GCP Inspection |
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| November 2021 | Toronto | Clinic/Bioanalytical Inspection | Recertification received |
| August 2021 | St Louis MO | Clinic Inspection | Certificate received |
| October 2019 | Toronto | Bioanalytical & Clinic Inspection | Re-certification/Certificate received |
| November 2017 | Toronto | Clinic Inspection | Certificate received |
| October 2017 | Toronto | Bioanalytical Inspection | Re-certification/Certificate received |
| August 2015 | Toronto | Bioanalytical Inspection | Certificate received |
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| July 2023 | Toronto | Clinic & Bioanalytical Inspection | Compliance with WHO GCP & Guidance |
| November 2018 | Toronto | Desk Assessment (Clinic & Bioanalytical Lab) | Compliance with WHO GCP & Guidance |
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| August 2019 | Toronto | GCP Inspection (Clinic & Bioanalytical Lab) | GCP Inspection Statement received |
| April 2016 | Toronto | GCP Inspection (Clinic & Bioanalytical Lab) | GCP Inspection Statement received |
| April 2013 | Toronto | GCP Inspection (Clinic & Bioanalytical Lab) | GCP Inspection Statement received |
| April 2010 | Toronto | GCP Inspection (Clinic) | GCP Inspection Statement received |
| Date | Site | Nature of Inspection | Inspection Report and Response |
|---|---|---|---|
| March 2023 | Toronto | Good Laboratory Practice (GLP) Inspection | Good Laboratory Practice (GLP) Certification (Pending Receipt) |
| March 2021 | Toronto | Good Laboratory Practice (GLP) Inspection | Good Laboratory Practice (GLP) Certification (Pending Receipt) |
| March 2019 | Toronto | Good Laboratory Practice (GLP) Inspection | Good Laboratory Practice (GLP) Certification |
| April 2017 | Toronto | Good Laboratory Practice (GLP) Inspection | Good Laboratory Practice (GLP) Certification |
| February 2015 | Toronto | Good Laboratory Practice (GLP) Inspection | Good Laboratory Practice (GLP) Certification |
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