Tag: iso 11135

How to Classify Systems Using GAMP 5 Categories

How to Classify Systems Using GAMP 5 Categories How to Classify Systems Using GAMP 5 Categories Step 1: Understanding GAMP 5 Framework The GAMP 5 framework lays the foundation for effective computer system validation (CSV) in the pharmaceutical industry. It…

Risk-Based Computer System Validation: Step-by-Step Process

Risk-Based Computer System Validation: Step-by-Step Process Risk-Based Computer System Validation: Step-by-Step Process In the pharmaceutical industry, the validation of computer systems is essential to ensure data integrity, compliance with regulatory requirements, and the safety and efficacy of products. The implementation…

What Is Design Qualification (DQ) and Why It Matters

What Is Design Qualification (DQ) and Why It Matters What Is Design Qualification (DQ) and Why It Matters In the highly regulated pharmaceutical and biologics industries, achieving compliance with established regulations and guidelines is crucial for delivering safe and effective…

IQ vs OQ vs PQ: Understanding the Key Differences

IQ vs OQ vs PQ: Understanding the Key Differences IQ vs OQ vs PQ: Understanding the Key Differences In the pharmaceutical and biotechnology industries, equipment qualifications play a crucial role in compliance, ensuring that any equipment used in manufacturing processes…

Process Design Phase Explained: Linking QbD to Validation

Process Design Phase Explained: Linking QbD to Validation Process Design Phase Explained: Linking QbD to Validation Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The User Requirements Specification (URS) is a critical element in the validation lifecycle. It…

Identifying Critical Quality Attributes (CQAs) and CPPs in Stage

Identifying Critical Quality Attributes (CQAs) and CPPs in Stage Identifying Critical Quality Attributes (CQAs) and CPPs in Stage In the highly regulated pharmaceutical industry, in-depth validation processes are essential for ensuring that products meet predefined quality standards. Understanding how to…