Reference no: EM13883530

GMP requirements for clinical trial material / investigational medicinal product manufacturing

Clinical Trial Materials (CTM) or Investigational Medicinal Products (IMP) are medicinal products used to confirm the efficacy and safety of the drug, which is in the trial stage, on human population. This means, clinical trial material is destined to be used by some of the most vulnerable patient populations (including the terminally ill).

The most important element about CTM is that there is very limited information available on the safety and efficacy of the medicinal product. Hence lot of care and attention is necessary for the manufacture and supply of clinical trial material as Quality Assurance of experimental material going into human beings for the first time is much more critical. This serves a dual purpose of eliminating risks to clinical trial volunteers (estimated at more than 40,000 annually and still growing ) the organization.

Are there any regulations / guidance documents available to understand the exact GMP requirements for such products ? Are GMP applied consistently for them ? Well the answer is yes and no too!. Why is this contradiction ? There appear to be two reasons for this.

1. summarise GMP requirements for clinical trial material