Quality Management System

InnovaVector has developed and implemented a Quality Management System (QMS) to demonstrate its ability to consistently provide products that meets any applicable regulatory requirements, and to address customer and patients’ satisfaction through the effective application of the system, including continuous improvement and the prevention of nonconformities.

This is based on the following standards and references:

  • EudraLex - Volume 4 - Good Manufacturing Practice (GMP) Guidelines Part I, III and IV - Basic Requirements for Medicinal Products
  • Related Annex 1, 11, 15 and 16
  • ICH Q9 and Q10
  • 21CFR part 211
  • UNI EN ISO 9001:2008 and 14644:2015

The Quality Assurance Department reviews every aspect of the manufacturing, from raw materials to final shipping, and makes sure that Good Manufacturing Practice are followed. Aseptic Process Simulation are periodically carried out in order to guarantee that the Drug Product is aseptically produced by qualified operators in qualified suites.

The release of the final Drug product is assured by a Qualified Person or its deputy, that certifies your Investigational medicinal products (IMPs) for use in clinical trials before shipping.

“The principles of quality, standardization, and process robustness guide us in ensuring the safety of your product for patients”