📝 Good Documentation Practices (GDP) in Pharmaceutical Quality Systems 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to define Good Documentation Practices (GDP) for all personnel working within pharmaceutical manufacturing, laboratory, and quality systems. Adhering to GDP ensures that all data generated, recorded, and stored is reliable, traceable, complete, and compliant with Good Manufacturing Practices (GMP) and global data integrity requirements. This SOP emphasizes adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) to maintain the integrity of both paper and electronic records. 2. Scope This SOP applies to all documentation generated under GMP conditions , including but not limited to: Batch manufacturing and control records Laboratory notebooks, logbooks, and analytical reports Validation protocols, reports, and records Electroni...
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