The requirement that investigational drugs imported into Europe be certified by an accredited Qualified Person (QP) before clinical trials can begin - set out under EC directive 2001/20/EC and Annex 13 of the European GMP guide - can be a hurdle for pharma firms that lack such personnel.
To address this need a number contractors offer consulting services designed to guide companies through this process, the newest of these is Northern Ireland-based Almac which launched what it calls a 'qualified person facilitation programme' earlier this week.
However, while Almac is not the only firm to offer guidance on supply chain assessment, documentation and other aspects of QP release it is the only one to do so at customer sites according to global VP of Quality Paul O’Connor, who told Outsourcing-pharma.com that: “Placing a QCM at the client site is unique.”
“Other companies offer the consultative aspects of the service, but not as an on-site service” he explained and predicted that “clients will find the QP Release process more straightforward and accomplish necessary documentation in a more timely fashion.”
O’Connor also stressed that while customers will gain QP knowhow and insight through the new service it is intended to be an overview rather than a specific training programme for clients’ staff.
“This is a consulting service only and will not provide the level of training necessary for QP accreditation. The on-site service aims to improve the client understanding of the process and supplement a lack of internal resources in moving through the release process.”
Individual projects will take between two and three days according to O’Connor with told us that Almac has sufficient quality managers to meet expected demand but is prepared to handle multiple programmes simultaneously if necessary.
O’Connor did not disclose how much it will charge for the new service on the basis that cost will vary on a project to project basis dependent on the client’s specific requirements and the time needed to complete the consultation.