Take Control of your Supply Chain

Are you really in control of your suppliers and your supply chain(s)?
Are you struggling to catch up with your supplier qualifications post-COVID-19?
Are you working to meet year end supplier review deadlines?
control your supply chain

Image by Freepik

While manufacturing and supply chain diversity can be enablers of product availability, increasingly complex supply chains lead to interdependencies that can introduce systemic quality/manufacturing risks impacting supply chain robustness.
– International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines Q9

Chapter 7 of the EU Good Manufacturing Practice (GMP) Guidelines state: “Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled” and the pharmaceutical manufacturer is responsible for controlling all outsourced activities, incorporating quality risk management principles and continuous reviews of the quality of their suppliers performance.

ICH Guidelines Q9 on quality risk management also makes specific references to supply chain risks, including the role of quality risk management in addressing product availability risks arising from quality/manufacturing issues.

Our highly experienced team of pharmaceutical quality professionals, which includes EU QPs, RPs and RPis, at JensonR+ can assist you with assessing the status of your outsourced activities, reinforcing a collaborative relationship with your suppliers and ultimately minimising the risk of supply issues and patient impact

We offer the following services:

  • Professional, direct contact with your suppliers

  • Systematic review of audit reports and follow up CAPA

  • Risk Analysis and minimisation guidance
  • Review of Quality contracts to ensure clear delineation of responsibilities

  • Review of authorised Certification, accreditations and non-compliance searches

  • Detailed review and summary of Quality Events and complaints
  • Advice on best practice supplier qualification and approval process, including a robust internal process review.
  • Performing GxP audits
Contact us to find out more and to see how we could support you in these areas, visit our Quality pages.
Claire Crewe
Latest posts by Claire Crewe (see all)