Tagged "gmp"

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

Change Control — Process for GMP Manufacturing Facilities

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

Computerized System Qualification — Integration with CSV Lifecycle

How equipment qualification and computer system validation activities are coordinated for integrated systems.

Concurrent vs Prospective Validation — When Each Approach Applies

The difference between concurrent and prospective validation, and the circumstances that justify each.

Data Integrity — ALCOA+ Principles for Laboratory Records

What the ALCOA+ principles mean in practice for laboratory data and records.

Design Qualification (DQ) — Approach for New Manufacturing Equipment

How Design Qualification confirms proposed equipment design meets user and regulatory requirements before purchase.

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.

Installation Qualification (IQ) Protocol — Structure and Content

What a well-structured IQ protocol covers, from documentation checks to utility connections.

Laboratory Equipment Calibration Program — Frequency and Documentation

How a lab-wide calibration program is scheduled, documented, and kept audit-ready.

Operational Qualification (OQ) — Test Approach for Process Equipment

How OQ testing demonstrates equipment operates as intended across its specified operating range.

Performance Qualification (PQ) — Acceptance Criteria Development

How PQ acceptance criteria are derived to prove equipment performs consistently under real production conditions.

Quality Assurance

Product Recall Procedure — Classification and Notification Requirements

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

Requalification Frequency — Risk-Based Approach for Critical Equipment

How to set a risk-based requalification schedule for equipment critical to product quality.

Retained Sample Program — Storage Requirements and Retention Periods

What a retained/reserve sample program must maintain and for how long, by product type.

Revalidation Triggers — Criteria for Re-Executing Validation Studies

What changes typically trigger revalidation, and how that decision should be documented.

Quality Assurance

Self-Inspection Program — GMP Internal Audit Approach

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

Temperature Mapping — Qualification Approach for Cold Storage Units

How temperature mapping studies qualify cold storage units for reliable pharmaceutical storage.

Validation Master Plan (VMP) — Structure and Required Content

What a Validation Master Plan should contain to give a facility a coherent validation strategy.

Vendor Qualification — Documentation Requirements from Equipment Suppliers

What documentation should be requested from an equipment vendor to support the qualification effort.