Regulatory and Standard Setting Organizations

The company’s successful completion of facility and equipment qualifications gives it another biologics manufacturing option alongside its United States campus in Morgan Hill, Calif.

This paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.