Category: QA

The Quality Assurance (QA) category focuses on the systems and processes that form the foundation of GMP compliance. QA ensures that products are manufactured, tested, and released under controlled conditions that meet regulatory standards.

Key topics include pharmaceutical quality systems (PQS), documentation, deviation and CAPA management, change control, supplier qualification, product quality reviews (PQR), and inspection readiness. Risk-based approaches, data integrity, and integration with Quality Control (QC) are also highlighted.

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Corrective and Preventive Actions (CAPA) Plan in GMP

Corrective and Prevention Action (CAPA) Plan in GMP

Explore CAPA's role in GMP for pharmaceuticals: key processes, challenges, and strategies for regulatory compliance...
Worst Case Selection in Cleaning Validation

Worst Case Selection in Cleaning Validation

Optimize cleaning validation in pharmaceutical manufacturing with key strategies for selecting worst-case scenarios, ensuring product safety and efficacy....
Cleanroom Qualification and Validation in GMP

Cleanroom Qualification and Validation in GMP

Explore the critical steps of cleanroom qualification and validation within GMP environments, emphasizing the importance of design, operational standards, and...
Person Performing Process Validation Lifecycle

Process Validation Lifecycle: Risk-Based Approach

Discover the essentials of Process Validation Lifecycle with a risk-based approach. Learn how to ensure product integrity from development to...
People performing Process Validation in GMP facility

Process Validation in GMP

Discover the essentials of Process Validation in GMP, ensuring pharmaceutical quality through scientific and regulatory practices....
GMP vs GLP - 10 Key Aspects for Quality and Compliance

GMP vs GLP: 10 Key Differences for Quality and Compliance

Explore the key differences of GMP vs GLP and how these practices warrant the highest industry standards....
Temperature Mapping in GxP Environment

Temperature Mapping in GxP Environment

Explore essential strategies for mitigating risks in temperature-controlled environments, ensuring product stability and safety in pharmaceutical storage....
Out of Specification Results Dealing with OOS Investigations in Pharma

Out of Specification Results: OOS Investigations in Pharma

Learn about all the phases of addressing Out of Specification (OOS) results in the pharmaceutical industry...
Cleaning Validation of Equipment in Pharmaceutical Industry

Cleaning Validation In the Pharmaceutical Industry

Explore the essentials of cleaning validation in the pharmaceutical industry, including all necessary steps, challenges, and regulatory standards....
Quality Assurance vs Quality Control in GMP

Quality Assurance vs. Quality Control in GMP: Key differences

Explore the critical differences between Quality Assurance and Quality Control in GMP and learn more about their role within the...

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