The manufacture of any pharmaceutical product, whether for clinical trial or market use, requires a Qualified Person (QP) to certify that it has been manufactured in accordance with the relevant Good Manufacturing Practice (GMP) legislation for the region it is released into.
In the case of an Investigational Medicinal Product (IMP), the QP must ensure the product has complied with the clinical trial authorisation, and for an Authorised Medicinal Product (AMP), the marketing authorisation.
As part of batch certification, the QP must assess the supply chain for adherence to GMP, through audits, as well documentation reviews and investigations of Quality Events.
For batch certification, laboratories and manufacturing sites in the EU and UK, The CQA Company (an Arithmos company) customers benefit from access to our in-house, EU and UK licensed Qualified Person.
We conduct QP and GMP audits, provide bespoke consultancy and review batch documentation for QP certification.
Background and challenges
Our client, a medium sized, clinical-stage company researching genetic therapies, required support with their audit schedule.
With an established QA team based in the United States, our client was looking for a UK based partner to meet their auditing needs in the EU and UK, and to provide specialist regulatory knowledge of EU and UK GMP.
In addition to assuring the compliance of their supply chain (with an estimated 10-15 audits), the client required batch review and certification, and importation to the UK and EU for three products, which included active substances and critical starting materials.
Due to the number of audits required, three auditors were assigned to the project to ensure availability of resource at short notice. An additional US based auditor was later added to the project team to deliver US audits with lower travel expenses for the client.
A Quality Plan was put in place to define the roles, responsibilities and working practices of all project team members from Arithmos as well as client-side team members. In addition, the Quality Plan detailed the project scope, planned activities and the applicable instructions to describe its execution.
The client requested that their Standard Operating Procedures (SOPs) and templates were used for the conduct of the audits and writing of the reports.
A shared portal was created to allow the secure transmission of documentation and reports, and the project team were appropriately trained on client SOPs and policies.
A schedule of work was prepared to provide a guideline for expected timings, along with milestone dates. This was utilised by both parties as a dynamic tool to allow for adjustments in client priorities and vendor availability. Where possible, audits within the same geographical region were scheduled consecutively to reduce travel time and travel expenses.
Regular consultancy calls were scheduled to facilitate the smooth running of the project and to provide regulatory guidance and advice where required.
Success factors and outcome
The successful partnership between Arithmos and the client was fundamentally due to the robust management approach for the project, providing a reliable framework for communication, audit planning and scheduling, and the execution of deliverables on time and within budget.
Since the initial collaboration in 2020, Arithmos has continued to operate as the client’s chosen QA partner, providing expert consultancy, QP services and GxP audits.
Are you looking for a Quality Assurance partner to support your international audit schedule, and ensure regulatory compliance for importation into the UK and EU?
Our global audit team is composed of highly experienced GxP specialists, with a detailed understanding of the nuances between local regulatory bodies, including AIFA, EMA, FDA and MHRA.
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Our Quality team has grown through our 2022 acquisition of The CQA Company, based in the UK, and now delivers over 150 audits per year.