Packaging clinical trial supplies

Synthesis of active ingredients Preclinical testing Formulations development Phase I, II, III, and IV clinical trials Clinical trials supplies manufacturing Clinical packaging... 

Note that semi-automatic blister packaging employing large preformed trays which are filled by hand then lidded from reel or sheet, followed by punching-out or guillotining, can offer speeds of around 1,200 items per minute with two or three operators. Under such conditions prices can be reasonably competitive with more sophisticated automatic equipment, particularly if runs are relatively short and a variety of tray and product sizes are involved. This can be particularly useful for clinical trial supplies. 

Dolfini, D.M. and Tiano, F.J., 2006, Clinical supply packaging. In Monkhouse, D.C., Carney, C.F., and Clark, J.L., (Eds), Drug products for clinical trials, 2nd Edition, Taylor Francis, 311-352. 

It shonld be shown that statistical procednres and fnnctions (e.g., SAS PROCS), supplied as part of a COTS product, are used correctly within the context of the program. Software that antomates the data analysis process across a nnmber of clinical trials should be vahdated in the same way as other supplier or custom (bespoke) systems. However, the vahdation requirements for trial-specific, one-off programs written nsing COTS package native languages are reduced. Specific issues to consider during validation are ... 

Once several batches of raw materials have been reviewed and tested to demonstrate that they will conform with the functional and quality requirements, the full excipient and packaging specifications can be finalised. Excipient and pack performance should be evaluated from a stability evaluation of the product and feedback from experience in clinical trials. Ideally, the specifications should be finalised for the start of Phase III clinical trials. If for some reason, the excipient or packaging material has to be changed for Phase III supplies, then some or all of the steps involved in the selection of materials, compatibility and stability studies may have to be repeated. 

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