Regulation EC/1394/2007, published on 13th December 2007, includes Somatic Cell Therapy, Gene Therapy and Tissue Engineering under the term "Advanced Therapies" and defines the used products as "Advanced Therapy Medicinal Products" (ATMP). The requirements for risk management have been tightened. Furthermore full traceability for all starting and raw materials must be warranted.
Hence, thanks to its experience, Bio Elpida proposes to help you with your regulatory matters.
3 questions à Yann RENOUARD*, Responsable Validation et Métrologie
What is validation?Validation is one of the important steps to present a case to the health authorities. Validation allows, with supporting documents, to demonstrate that a method or an analytical method reproducibly leads to the expected results.
According to GMPs: it is a "documented program that provides a high degree of assurance that a specific process, method or system will consistently provide a result that meets predetermined acceptance criteria".
What is it used for?Validation is used to demonstrate the control of critical aspects of a new process or to demonstrate that significant changes in plant, equipment or process have no impact on the quality of a product. These critical aspects of a new process are defined when performing a risk analysis.
What does Bio Elpida offer in this context?Bio-Elpida can help you carry out your validations, write the protocols, carry out the operations and save the corresponding reports by following the applicable references (ICH, PE or USP) thanks to a multidisciplinary team.
Bio-Elpida also conducts:
- Equipment qualifications (IQ, OQ, PQ) according to Annex 15 of the GMP and USP (1058),
- Analytical validations according to ICH Q2 and USP (1025),
- And process validations according to Annex 15 of the GMP.
* Yann RENOUARD served as Quality Control Manager in ABBOTT and GSK laboratories. He was also a Process Validation Consultant for SANOFI PASTEUR. Yann RENOUARD joined Bio Elpida in September 2015.