Quality Context were recently appointed to conduct a programme of GMP and GLP audits on behalf of a small, biopharmaceutical company. This involved the conduct of API manufacturing facilities, GLP laboratories, GMP laboratories and stability testing facilities and IMP manufacturing sites.

Quality Context managed the project from start to finish, from first introduction to site through the setting of audit agendas, selection of appropriate auditors, writing of comprehensive reports and production of timely CAPA plans and audit certificates.

Quality Context updated the client on a regular basis with full details of the progress of the programme and was able to assist the client with delivering a full programme of audits to meet their tight deadlines.