Embrace eBMR : 3 Key elements to Meeting Global Pharma Regulations – EU Annex 11; 21 CFR 11; Data Integrity – The core purpose of The Digital Imperative relating to eBMR application is to document every step of the manufacturing process
Navigating the Pitfalls of MSAT for Successful Technology Transfer: In the biopharmaceutical sector, MS&T responsibilities extend to both upstream and downstream processes. This includes optimizing cell culture conditions, managing bioreactor performance, and ensuring effective purification
The pharmaceutical industry stands at a crossroads where regulatory expectations continue to evolve, patient safety remains paramount, and competitive pressures demand operational excellence. In this complex landscape, organizations …
The Raw Material Risks You Can’t Afford to Ignore: Ignoring raw material risks like unpredictable supply chains, political upheaval, or dwindling resource can seriously disrupt production, drive up costs, and weaken a company’s ability to bounce back.
Pharmacovigilance, the science, and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems, is critical in patient safety.