Critical Utilities GMP Compliance and new Annex 1

New Annex 1, among other important points considered, dedicates several comments on the importance and the impact of Critical Utilities, involved at different level either because directly impacting on Contamination Control Strategy (CCS) document, or because potential direct or indirect source of bio-contamination of the final product.

GMP Compliance Expert | Osaka (Japan)

New GILS rules powered by PQE

PQE and SID&GP, together for Data Integrity guidance

PQE Group is proud to announce that the draft of the new Russian Guide for Industrial Data Integrity has been published on the website of GILS – Russian State Institute of Drugs and Good Practices. After the collaboration with COFEPRIS, the Mexican Regulatory Authority, for the creation of the data integrity chapter of the NOM […]