Quality Context was recently appointed by a leading global pharmaceutical company to redesign and help implement a new labelling system across their business which operates in over 80 markets around the world.
Our core team included experts with detailed understanding of labelling legislation in key markets: Europe, North America, Australia, South Africa and ASEAN countries.

Scope

We were tasked with:

  • Finalising a sustainable, globally acceptable process for updating existing labelling that is grounded on industry best practice, meets current regulations and is applicable to the specific needs of the client.
  • Developing a set of integrated SOPs to describe this global labelling process through multi-functional, multi-region working groups of stakeholders and subject matter experts.
  • Clearly defining and articulating within the SOPs the roles and responsibilities of business functions throughout the process.
  • Implementing (including alignment of roles with jobs) and embedding these SOPs globally through training and communication and monitoring their effectiveness through KPIs and qualitative reviews.

Solution

Deliverables:

  • A defined 10-stage process that helped the business scope, design, train-out and implement the new labelling systems.
  • A comprehensive engagement programme that ensured staff participated in these redesigning their core business processes and encourage ownership of the new system.
  • A tailored training solution that provided staff with the skills and confidence to use the new systems and ensure compliance.
  • A follow-up mock inspection 6 months after the new system went live to ensure that systems had been embedded and were sustainable.

Success

  • We delivered the entire end-to-end programme on time and on budget.
  • We ensured that the system went live following extensive training.
  • Our system was assessed by a competent authority in a major market during a recent pharmacovigilance inspection and found to be entirely compliant with no major, critical or other findings.