
How to Prepare for a GMP Audit: Consultant-Recommended Documentation and Training Tips
The announcement of a Good Manufacturing Practice (GMP) audit often instills anxiety among pharmaceutical, biotech, or medical device facilities. The
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The announcement of a Good Manufacturing Practice (GMP) audit often instills anxiety among pharmaceutical, biotech, or medical device facilities. The

In the competitive landscape of life sciences, the Regulatory Affairs (RA) division has evolved from merely a compliance-related function into

In the dynamic landscape of the pharmaceutical industry, drug discovery represents only the initial phase of a much more complex

In the domain of clinical research, the announcement of a Good Clinical Practice (GCP) audit is often met with apprehension,

In the competitive and highly regulated pharmaceutical industry, the goal of growth introduces complexity in various operational areas, particularly in

For decades, the standard practice in clinical trial monitoring involved a uniform method characterized by 100% Source Data Verification (SDV)