A high-level document describing the entire Quality Management System (QMS) , including its scope and the interaction between processes.
Documentation is typically organized in a "pyramid" structure, moving from high-level strategic policies to granular, task-specific records. 1. Level 1: Apex/Strategic Documents list of qa documents in pharmaceutical industry
These define the organization's quality philosophy and broad commitments to regulatory bodies like the FDA, EMA, or WHO. Corrective and Preventive Actions (CAPA)
Developing and Maintaining SOPs. QA is responsible for drafting, reviewing, and regularly updating Standard Operating Procedures ( list of qa documents in pharmaceutical industry
Management of deviations, Corrective and Preventive Actions (CAPA), and internal quality audits (self-inspections). 3. Level 3: Tactical Instructions & Methods Lab Manager An Introduction to Pharmaceutical QA (Quality Assurance)