The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them. In November 2008, the US Food and Drug Administration issued Draft Guidance for ...

The Office of Personnel Management on Friday urged agencies to rethink how they hire federal workers, with an emphasis on “competencies” and allowing more employees outside of HR into the process. In ...

In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...

Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official ...

This is not the current manual. From January 2015, guidelines were developed using Developing NICE guidelines: the manual. The National Institute for Health and Clinical Excellence (NICE) is the ...

HHS is only one of the many agencies that issued a “good guidance” rule in response to an executive order issued by President Trump in October 2019. The executive order raised concerns that agencies ...

This note provides operational guidance on the use of the Precautionary and Liquidity Line (PLL). After an overview of the instrument explaining its specific nature, the operational issues are grouped ...