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August 02, 2019
A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
July 17, 2019
MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.
The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.
July 10, 2019
FDA released draft guidance on using the USP pending monograph process in the drug application process.
July 02, 2019
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?
June 25, 2019
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
June 03, 2019
The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.
May 02, 2019
Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.
April 02, 2019
Confidence in the quality systems and scientific competence of the API manufacturing team is essential.
Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.