Documentation in the realm of pharmaceutical manufacturing is the systematic creation, maintenance, and management of records, reports, and electronic materials that capture the essence of operations, processes, and outcomes. It is vital for ensuring traceability, accountability, regulatory compliance, and quality assurance. Documentation spans a variety of formats, including policies, procedures, specifications, and records, playing a pivotal role in auditing, training, and fostering continuous improvement. This discipline underscores the importance of meticulous record-keeping to uphold GMP standards and ensure operational integrity.
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