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By Marcelo Trevino | The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. | |
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| USP Draft Chapters On CCS: What You Need To Know | Article | West Pharmaceutical Services, Inc. | Learn why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations. |
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| High-Volume Manufacturing: Essential Points To Consider | White Paper | Pharma & MedTech Partner Division, B. Braun Medical Inc. | To successfully scale to high-volume manufacturing, planning is required for streamlining the production process and minimizing the changes that could add unnecessary time and expense to the process. |
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