Tag: Analytical Method Validation

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USP–NF PF 51(6) draft updates announced for November 2025, including revisions to chapters ⟨1225⟩ Analytical Lifecycle, ⟨1771⟩ Ophthalmic Products, ⟨1664.1⟩ and ⟨1664.3⟩ Leachables for OINDP and Eye Drops, and ⟨825⟩ Radiopharmaceutical Standards.

USP–NF PF 51(6) Draft: What is New?

USP–NF PF 51(6) draft updates modernize analytical validation, ophthalmic standards, leachables guidance, and radiopharmaceutical practices....
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....
USP Releases New Draft Proposals in Pharmacopeial Forum 51(4) - Featured Image

USP–NF PF 51(4) Draft Published

USP–NF PF 51(4) introduces draft chapters on data integrity, suspensions, disinfectants, chemometrics, and analytical lifecycle, impacting GMP pharma operations....
Method validation vs method verification: Key Differences

Difference Between Validation and Verification of Analytical Methods

Learn the key differences between method validation and verification in pharma labs, with clear guidance on when each applies and...
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FDA Issues Warning Letter to ABR Laboratory LLC Over Quality Control Failures

FDA warns ABR Laboratory LLC for failing to validate test methods and investigate deviations, risking drug safety. Learn key compliance...
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...
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Performance Characteristics in Analytical Method Validation: Understanding the Significance

Learn how method validation performance characteristics align with GMP to ensure consistent industry-compliant results....
The-Importance-of-Analytical-Method-Validation

Analytical Method Validation & Its Role in Lab Testing

An overview of analytical method validation and its critical impact on testing accuracy, reliability, and compliance with regulatory standards....

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