Tagged "quality-assurance"

Quality Assurance

Annual Product Quality Review (APQR) — Required Content and Structure

What an Annual Product Quality Review needs to cover and how findings should be used.

Quality Assurance

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

Change Control — Process for GMP Manufacturing Facilities

How a change control process evaluates and manages the risk of planned changes in a GMP facility.

Quality Assurance

Deviation Management — Root Cause Analysis Approach

How a structured root cause analysis process turns a deviation into a real corrective action.

Quality Assurance

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

Product Recall Procedure — Classification and Notification Requirements

How recalls are classified by risk level and what notification obligations follow from each class.

Quality Assurance

Self-Inspection Program — GMP Internal Audit Approach

How a self-inspection program is scheduled, scoped, and used to drive continuous improvement.

Quality Assurance

Supplier Qualification — Approach for Raw Material Vendors

How raw material suppliers are risk-assessed, audited, and approved under a supplier qualification program.