“AI can create digital replicas of manufacturing processes, allowing companies to model ‘what-if’ scenarios, ... EMA’s Annex 15 on Process Validation, ...

Company has Successfully Completed the Production of Three Process Validation Batches at Commercial Scale Completes a Substantial Requirement Toward the Planned Submission of D-PLEX100 NDA and MAA ...

Users can configure their production records and validate in one simple step.SALT LAKE CITY, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Today, MasterControl, a leading provider of quality management and ...

Akalkotkar: Companies should follow the regulatory guidelines for process validation. The cGMP regulations require that the manufacturing processes be designed and controlled. If the guidelines are ...

Girindus has won its second process validation contract this year. The process is for the manufacture of an oligonucleotide currently in Phase III testing. It has been granted orphan drug status and ...

BOE failed Apple's validation - needs to upgrade its manufacturing process. At the best case scenario, BOE may still supply 2 million units to Apple.

Since mid-September, shares have pulled back from an all-time high of $389.61 as the company announced that Model 3 production fell short of estimates due to manufacturing bottlenecks.

The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them. In November 2008, the US Food and Drug Administration issued Draft Guidance for ...

--PolyPid Ltd., a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of the production of three process validation batches of D-PLEX 100 ...