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 ...

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 ...

No additional expectations or mandated requirements are expected in Q14, Q2(R2) and USP <1220>. The minimal approach can still be used. Q14 and Q2(R2) are consistent with the principles described in ...

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 ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it can give very good advice when validating laboratory Total Organic ...

The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

Market opportunities exist in the development and validation of liquid chromatography methods and instruments for pharmaceuticals, emphasizing compliance with stringent US EPA and FDA standards to ...