Quality and Regulatory

We are very proud of our quality and regulatory track record; it is core to our business and our future success

Commitment to quality

Quality is at the heart of what we do at Sterling; we take our responsibilities as a drug substance manufacturer very seriously. We understand the importance of the quality of the products we develop and the impact that this has on patients. ... Read more

Whilst we have a global quality team of over 150 people, quality is everybody’s responsibility whatever they do within the business. Our quality management system ensures our policies and procedures are documented for all employees and a comprehensive training programme ensures a detailed understanding of expectations. We regularly audit ourselves on against regulatory standards to ensure consistent adherence.

We have an integrated global strategy headed up by our Vice President of Global Quality, Ian Lisle, which ensures best practice is shared and we continue to plan, deliver and sustain excellent quality standards for our customers, whichever facility their project is handled by. Read less

Commitment to regulatory requirements

As part of one of the most regulated industries in the world, it is no surprise that Sterling is committed to meeting its requirements of the various regulatory bodies, as well as supporting our customers to do so. ... Read more

We are extremely proud of our regulatory record and the peace of mind it provides to our customers.

We are also able to handle the most hazardous chemical processes, making quality, HSE and regulatory compliance fundamental to everything we do.

As well as the audits set out below, we have over 50 customer audits a year at our facilities. Read less

Regulatory audits

  • Registered with the FDA as a bulk API manufacturer
  • Successful general and PAI inspection April 2018
  • DEA approved to import, store, manufacture and export Schedule II-IV controlled substances.
  • Successful ISO/IEC 27001:2017 certification audit February 2024
  • Mutually recognised by the FDA (based on the successful MHRA inspection) September 2021
  • Successful MHRA cGMP inspection June 2021
  • Project specific PMDA approval June 2021
  • Successful drug product MHRA audit August 2020
  • Successful MHRA assessment October 2019
  • Successful VGNKI (Russian) cGMP inspection May 2018
  • Successful FDA cGMP inspection May 2018
  • Successful MHRA cGMP inspection June 2017
  • Successful drug product MHRA audit May 2016
  • Successful FDA general inspection November 2014
  • Successful API MHRA audit October 2013
  • Successful FDA pre-approval inspection (PAI) May 2011
  • Successful PMDA pre-approval inspection (PAI) July 2011
  • UK Home Office approved to import, store, manufacture and export Schedule 1-3 controlled substances
  • Successful PMDA inspection April 2022
  • Successful Australian TGA inspection April 2022
  • Successful DEA inspection March 2019
  • Successful DEA inspection June 2018
  • Successful DEA inspection for registration March 2017
  • Successful FDA cGMP inspection June 2016
  • Successful FDA cGMP inspection September 2013
  • Successful FDA cGMP inspection December 2011
  • DEA approved to import, store, manufacture and export Schedule I-V controlled substances.

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Sterling Snapshot | Victoria Waddington, Regulatory Affairs Manager

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Making sense of regulatory requirements