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   ✅  Proposed GLP Quality System: Data Quality and Integrity

With regards to data quality and integrity, the proposed FDA GLP changes aim to produce better data with less chance of bias. In this report we detail the introduction of “ALCOA” as well as new requirements for including data in reports…


   ✅  Proposed GLP Quality System: Quality Assurance Unit (Part 1 of 2)

As the process of reviewing the FDA-proposed GLP Quality System changes continues, we break down the proposed changes, rationale, and industry impacts in detail…


   ✅  Proposed GLP Quality System: Quality Assurance Unit (Part 2 of 2)


   ✅  Proposed GLP Quality System: Definitions


   ✅  Proposed GLP Quality System: Testing Facility Management with Executive Responsibility


   ✅  Proposed GLP Quality System: Sponsor Responsibility


   ✅  FDA Proposed GLP Comparison

Proposed GLP Quality System vs. Current GLP Regulations The Food and Drug Administration (FDA) on August 24, 2016, published a proposed rule which would amend regulations. These rules govern good laboratory practices (GLPs) for nonclinical laboratory studies to…