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July 03, 2023
The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.
FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.
July 02, 2023
Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.
June 02, 2023
Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.
May 02, 2023
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
A strategy on cyber resilience for health and social care organizations has been set out by the UK government.
April 02, 2023
FDA has spurred investment to create and develop 600 therapies.
A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
March 21, 2023
Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy.
March 15, 2023
Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.