Fill/finish specialist SCM delivered this phase of the study from its GMP facility, which involved the encapsulation of an active tablet of differing strengths and a placebo for a randomised, double blind and crossover clinical trial. Packaging and labelling for the study and packing into patient kits with randomisation envelopes were also included. Cambridge University’s department of clinical medicine headed the project, which investigated the anti-inflammatory effects of an angiotensin-converting enzyme inhibitor, lisinopril.
As the trial was with patients suffering from rheumatoid arthritis, which can affect the hands, SCM recommended using tamper-evident HDPE bottles, which were child-resistant and included 'arthritis-friendly' tops.
The set-up phase required SCM's expertise in generating specifications and documentation, originating label design, sourcing and purchasing materials, issuing batch documents and printing labels.
Following production, SCM's in-house Quality Assurance (QA) and Quality Control (QC) teams analysed the quality of the finished products.
SCM has two sites in the UK, offering a range of solutions from its MHRA-approved manufacturing facility. In addition, it provides testing services and consultancy.
Contact T: +44 1661 838186 www.scm-pharma.com