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April 04, 2018
April 03, 2018
Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.
The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.
April 02, 2018
Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.
Peter Stein, MD will present FDA’s keynote presentation at the CPhI North America conference on Thursday, April 26, 2018 in Philadelphia, PA.
Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.