Tag: Process validation

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fda-warning-letter-analysis

FDA Warning Letter Analysis: Dabur India Limited

FDA Warning Letter analysis of Dabur India Limited covering CGMP violations, data integrity failures, import alert, recalls and remediation expectations....
Featured image for a news article about the new PIC/S Qualification and Validation Guidance (PI 006-4), highlighting major updates to process validation, cleaning validation, equipment qualification, and quality risk management effective from August 2026.

PIC/S Issues PI 006-4 on Qualification and Validation, Effective 1 October 2026

PIC/S PI 006-4 introduces major updates to qualification and validation, including process validation, cleaning validation, qualification, data integrity, and quality...
EU GMP Annex 15 revision concept paper highlights showing pharmaceutical filling equipment and operator, representing proposed changes to qualification, validation governance, investigations, and lifecycle control for 2026.

EU GMP Annex 15 Revision to Cover Active Substances: Concept Paper Highlights (2026)

EMA & PIC/S consult on revising EU GMP Annex 15 for active substances: scope, Q&V governance, investigations, CPV and GDP...
Cleanroom equipment with text overlay showing comparison of qualification and validation in GMP.

Qualification vs Validation: Key Differences in GMP

Qualification vs. Validation explained for GMP professionals — clear regulatory differences, lifecycle expectations, and real-world applications across pharma systems....
Validation Master Plan (VMP) In the Pharmaceutical Industry

Validation Master Plan (VMP) In the Pharmaceutical Industry

Learn how to create a comprehensive Validation Master Plan (VMP) to ensure consistent product quality and regulatory compliance...
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....

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