标签为 "quality-assurance" 的结果
清除筛选Quality Assurance
2026年8月24日
Annual Product Quality Review (APQR) — Required Content and Structure
What an Annual Product Quality Review needs to cover and how findings should be used.
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Quality Assurance
2026年8月24日
CAPA (Corrective and Preventive Action) — System Design per ICH Q10
How a CAPA system is structured under the ICH Q10 pharmaceutical quality system model.
Quality Assurance
2026年8月24日
Change Control — Process for GMP Manufacturing Facilities
How a change control process evaluates and manages the risk of planned changes in a GMP facility.
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Quality Assurance
2026年8月24日
Deviation Management — Root Cause Analysis Approach
How a structured root cause analysis process turns a deviation into a real corrective action.
Quality Assurance
2026年8月24日
Document Control System — GMP Requirements for SOPs and Records
What a compliant document control system needs to manage SOP lifecycle and record integrity.
Quality Assurance
2026年8月24日
Product Recall Procedure — Classification and Notification Requirements
How recalls are classified by risk level and what notification obligations follow from each class.
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Quality Assurance
2026年8月24日
Self-Inspection Program — GMP Internal Audit Approach
How a self-inspection program is scheduled, scoped, and used to drive continuous improvement.
Quality Assurance
2026年8月24日
Supplier Qualification — Approach for Raw Material Vendors
How raw material suppliers are risk-assessed, audited, and approved under a supplier qualification program.