PharmTech

Final Analytical Procedures Guidance Published

On March 7, 2024, FDA published two final guidance documents regarding analytical procedures in order to facilitate regulatory evaluations and flexibility in postapproval change management of ...
PharmTech

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

ICH Q14 Draft Guideline: Analytical Procedure Development In March 2022, the ICH Q14 draft guideline was published for public consultation aiming to describe science- and risk-based approaches for ...
technologynetworks

Applying a Lifecycle Approach to Your Analytical Procedures and Method Validation Programs

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...
Labroots

Quality Control for the Pharmaceutical Industry; Stage 3, Continued Verification, in the Lifecycle of Analytical Procedures

QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At the same time, the number of tests run by QC laboratories is ...
Yahoo Finance

2 Day Lifecycle Management of Analytical Methods and Procedures Course: Current Trends & Your Questions Answered (January 19-20, 2023)

Dublin, Nov. 18, 2022 (GLOBE NEWSWIRE) -- The "Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered" training has been added to ResearchAndMarkets.com's ...
JSTOR Daily

Pattern Recognition, Hypotheses Generation, and Auditor Performance in an Analytical Task

Professional standards for analytical procedures call for auditors to hypothesize likely causes of unexpected patterns in financial statement balances and to develop plans to investigate (SAS 56).