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March 15, 2022
Why critical thinking must be applied before technology to ensure regulatory compliance.
This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.
March 03, 2022
Process performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.
A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
March 02, 2022
Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.
February 24, 2022
USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.
February 16, 2022
Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution
February 08, 2022
With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.
February 07, 2022
A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.
February 02, 2022
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.