Biopharmaceuticals – or biologics – are a rapidly growing segment of the global pharmaceutical market that has revolutionized the management of hard-to-treat diseases such as cancer and autoimmune ...

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data. The principles of quality by design (QbD) and life cycle management, as outlined in ...

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 ...

Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...

Are you ready for ICH Q14: Analytical Procedure Development and the revision of ICHQ2(R1) Analytical Validation? These guidance’s, intended to be published by 2021, complement Q8 to Q12 and aim to ...

Dublin, Dec. 04, 2024 (GLOBE NEWSWIRE) -- The "Analytical Methods Validation for FDA Compliance Drugs and Biologics" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...

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 ...

The new industrial revolution, “Industry 4.0,” has been leading to changes in the pharmaceutical industry (“Pharma 4.0”), where significant paradigm shifts have been occurring in the pharmaceutical ...

IMGCAP(1)]Documenting audit and review procedures often feels more like administrative than value-adding work. Processing Content And some procedures—like analytics, for example—require more extensive ...

Intimate Connectivity Must Be Maintained Throughout the Product’s Lifecycle The link between product specifications and analytical methods throughout a product’s lifecycle makes intuitive sense. One ...