Quality Documentation

• Quality Documentation refers to all records maintained to ensure compliance with Good Documentation Practices (GDP).

Types of Quality Documentation

1. Manufacturing and Testing Records (BMR, MFR).
2. Validation and Qualification Reports.
3. Calibration and Maintenance Records.
4. SOPs, Policies, and Guidelines.
5. Deviation and CAPA Reports.
6. Change Control Documentation.
7. Audit Reports and Quality Review Reports.

All quality documents must be securely stored for regulatory compliance and traceability.

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