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.
The second draft of GMP Annex 1 has been recently released and the issue date for the new revision is finally approaching. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended.
GMP Compliance Expert | Osaka (Japan)
PQE Group is delighted to announce its new partnership with Rephine, a UK based multinational audit and consultancy company
PQE Group 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 […]