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August 31, 2023
The updated vaccine will be ready to ship following a positive European Commission review.
August 11, 2023
The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.
July 20, 2023
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.
July 13, 2023
The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.
May 18, 2023
The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.
May 01, 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.
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.
This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) , and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.
March 01, 2023
Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.