Defines what a user needs from equipment or software. Qualification Protocols (DQ, IQ, OQ, PQ): DQ: Design Qualification. IQ: Installation Qualification. OQ: Operational Qualification. PQ: Performance Qualification.
A QA-managed register of suppliers vetted and approved through audits and quality agreements.
Defines how documentation is created, reviewed, approved, distributed, and archived. list of qa documents in pharmaceutical industry
: Documentation of lab results for every batch.
: A global document describing how the company complies with specific Good Manufacturing Practice (GMP) regulations. Quality Policy Defines what a user needs from equipment or software
Summaries of inspections conducted on suppliers, contract laboratories, or third-party logistics providers.
Documentation proving that the entire manufacturing process consistently delivers a product meeting all quality attributes. 6. Risk Management and Audit Documents OQ: Operational Qualification
These are critical for handling unplanned events and planned improvements.
The official record of a specific batch, showing the step-by-step production history from raw material to finished product.
These are essential for proactively identifying issues and driving quality improvements.