GAMP

What is Data Validation and Cleaning in GAMP 5

In the realm of Good Automated Manufacturing Practice (GAMP) 5, data integrity reigns supreme. High-quality decisions rely on trustworthy data, and GAMP 5 provides a framework to ensure the accuracy, completeness, and consistency of electronic records throughout their lifecycle. This blog delves into the crucial aspects of data validation and cleaning within the GAMP 5 …

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GAMP Categories of Good x Practice (GXP) Application

In the pharmaceutical industry, ensuring patient safety and product quality is paramount. This extends to the computerized systems used throughout the development, manufacturing, and distribution processes. GxP (Good X Practices), a series of regulations outlining these practices, plays a crucial role. But how do we determine the appropriate level of validation for these computerized systems? …

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GAMP guidelines – A risk based approach in Pharma Industry

The world of pharmaceuticals demands unwavering trust. Patients rely on the safety and effectiveness of medications, and regulatory bodies hold manufacturers to stringent standards. In this environment, Good Automated Manufacturing Practice guidelines play a crucial role. Published by the International Society for Pharmaceutical Engineering (ISPE) [ISPE website], GAMP 5 specifically focuses on a risk-based approach …

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Category Of Software & Hardware As Per GAMP Guideline & their Validation

Category Of Software & Hardware As Per GAMP Guideline & their Validation Category of softwareApplication are categorized into following software categories as per GAMP 5 guideline Typical Approach for validation:- Record version number, verify correct installation by following approved installation procedure. Typical Approach for validation: – Validation of category 3 software may be performed directly …

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