Question

A new GMP facility is being established in Italy for the production of a therapeutic stem-cell product. a. Identify, with justification, what type of medicinal product this would be considered in the EU. b. Discuss some additional Good Practice measures that such a product may require. c. As per ICH Q7, identify two (2) key steps/process for which specific guidance regarding such a product is provided, and suggest at which step GMP compliance should begin. d. In addition to ICH Q7, write brief notes on further items required under European Legislation for GMP with regards to such a product.

Answer 1

1. The stem cell therapy medicines comes under ”Regeneratice medicines”. The European Commission imposed the “Regulation on Advanced Therapy Medicinal Products (ATMPs)” for GMP in this sector of medicines. It is a promising new therapy utilising a novel medicinal due to which stem cell therapy comes under this regulation.
2. The GMP for regenerative medicines requires some special adaptations that are quite advanced as compared to the conventional medicines. The nature of regenerative medicine like short shelf life, biological variability, product stability etc. poses come major challenges to the GMP for these products. It require control strategies based on a risk assessment to be regulated and monitored regularly.Some special GMP measures like the periodic autoinspection, special training for ATMP, Proper integration of the data in documented form, and advanced cell based laboratories different from normal biosafety lab to prevent cross- contamination, modification and improvement in selection and validation of raw materials for making it able for reprocessing, proper validation studies for quality controls.
3. As per ICH Q7 the key ateps at which the specific guidance regarding such product is provided are : The process equipment – cleaning, production and in-process controls as well as in documentation and quality management.The GMP compliance should begin at the initial level from sample collection by the lower staff as he should be properly trained to the common man involved in process. There is no scope of leniency in the process at any step.
4. Along with ICH Q7, there should be proper compliance of effective pharmaceutical quality system in accordance with International Standards Organisation (ISO) quality standards, proper regulations of pharmaceutical development and quality risk management. New "cluster" in addition to FDA and EMA norms of U.S for pharmacovigilance could also help the EU GMP to expand in order to provide quality.