FDA Collates GMP Data Integrity Advice Into Draft Guidance
This article was originally published in The Tan Sheet
A draft guidance in Q&A-format could help stave off missteps flagged in recent warning letters, more of which focus on data integrity. One basic piece of advice: data generated to satisfy a CGMP requirement is a CGMP record that must be retained.
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Pharmaceutical Inspection Cooperation Scheme member inspectorates are trying out the most comprehensive manufacturing data integrity guidance yet developed. Issued amid a flurry of guidance from various authorities, it could play a key role in harmonizing regulatory approaches.
New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.