| Good Documentation Practices (GDPs) refer to a set of internationally accepted guidelines for creating, managing, and maintaining accurate, complete, and traceable records. GDPs ensure that all documentation related to pharmaceuticals, biotechnology products, and medical devices complies with regulatory requirements such as GMP, GCP, and GDP. They govern how information is recorded (legibly, promptly, and accurately), corrected (without obscuring original entries), and maintained (securely and accessibly). Proper implementation of GDPs supports product quality, regulatory inspections (by regulatory agencies such as the FDA, EMEA, Swissmedic or WHO), data integrity, and ultimately, patient safety by ensuring that all critical processes are properly documented and verifiable throughout the product lifecycle. |
Good Documentation Practices (GDPs)
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