Aptuit | Compliance and audits

Compliance and audits

Compliance you can trust

All of our facilities are audited and approved by key regulators, and our clients always put our facilities to the test, ensuring we meet their high standards. All of Aptuit’s GMP, GLP and GCP operations comply with the stringent requirements of key regulators such as FDA, MHRA and other international regulatory offices.

Aptuit's compliance and audits

Oxford, UK

  • Pilot Plants regulated by Environment Agency: audited twice yearly
  • Controlled drug usage regulated by Home Office: audited every 3 years
  • Ethanol usage regulated by HMRC: audited every 3-5 years
  • Releases to sewer regulated by Thames Water and accredited to MCERTs, audited every 5 years
Certifications  
Certification type     Granted by (institution) Date of certification
ISO14004: 2004 BSI 2013, November 4th
ISO14004: 2004 BSI 2012, May 16th
ISO14004: 2004 BSI 2010, December 6th
ISO14004: 2004 BSI 2007, December 10th
ISO14004: 2004 BSI 2006, August 31st
ISO14004: 2004 BSI 2006, February 13th
ISO14004: 2004 BSI 2004, October 14th


Regulatory audits
Type Regulatory agency Date of audit
GMP MHRA 2014, November
GMP FDA 2013, September
GMP FDA 2013, August
GMP MHRA 2013, June
GMP FDA 2013, May
GMP MHRA 2012, November
GMP MHRA 2010, November
GMP MHRA 2009, March
GMP MHRA 2006, April


Client audits
Year Number of audits
2016 9 (up to July)
2015 12
2014 14
2013 8
2012 11
2011 9
2010 13
2009 11
2008 12
2007 8
2006 16
2005 13

 


Verona, Italy

Verona is the home of The Aptuit Center for Drug Discovery & Development, an impressive 700,000 sq ft facility that offers unique, integrated pharmaceutical outsourcing capabilities.

Certifications  
Certification type Granted by (institution) Date of certification + notes
GMP Certification for production of Active Pharmaceutical Ingredients (API) for clinical use AIFA (Agenzia Italiana del Farmaco - Italian Drug Administration) IT-API/128/H/2015 (October 2015)
Authorization to carry out analysis of samples from clinical trials according to Italian law DM 19 March 1998 "Recognition of fitness centers for clinical trials Medicines ". AIFA (Agenzia Italiana del Farmaco - Italian Drug Administration) Oct-15
GLP certification Ministry of Health - D.G. for Health Prevention Office VI Certificate: 2015/25 (Issued 08 September 2015)
AAALAC accreditation Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International) 04 Jun 2015 Full accreditation confirmed from Year 2011
GMP Certification for production of Investigational Medicinal Product (IMP) AIFA (Agenzia Italiana del Farmaco - Italian Drug Administration) IT/211-1/H/2014 (July 2014)
GCP Certification Auto certification according to Italian law: DM 31 March 2008 (Definition of minimum requirements for organizations contract research (CRO) in the context of clinical trials of medicines.) 09-Dec-10

 

Regulatory Audits  
Type Regulatory agency/institution Date of audit
GLP Italian MoH Mar-15
GMP AIFA (Agenzia Italiana del Farmaco) Mar-14
GLP Italian MoH Feb-13
GLP Italian MoH Sep-12
GMP AIFA Sep-12
GMP FDA Dec-11
GMP AIFA Jul-11
GMP AIFA Dec-10
GMP AIFA Sep-10

 

Client audits 
Year Number of audits per year Comments
2015 25 GMP + GLP
2014 23 GMP + GLP
2013 29 GMP + GLP
2012 26 GMP + GLP
2011 29 GMP + GLP
2010 5 Aptuit started 1st Jul 2010

 


Basel, Switzerland

Basel is the home of Exquiron (now part of the Aptuit group) where our services span from assay development and adaptation for hit finding and profiling purposes to compound selection, high throughput screening, selectivity testing and hit characterization, and SAR expansion

Regulatory Audits  
Type Regulatory agency/institution Date of audit
Ordinance on Occupational Safety in Biotechnology (SAMV) Swiss National Accident Insurance Fund (SUVA) Jan-15
Containment Ordinance (ESV) Cantonal Safety Inspectorate Feb-14

 

Certifications  
Certification type Granted by (institution) Date of certification + notes
IATA-DGR Certified Packer/Shipper Safety Training Plus GmbH 17 March 2016
Permit for handling ionizing radiation Swiss National Accident Insurance Fund (SUVA) 18 July 2013