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 ...
Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "Analytical Method Validation, Verification and Transfer Course" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...
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 ...
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 ...
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 ...
A variety of modern innovative analytical instruments, ranging from a simple apparatus to complex computerized systems, are used in the pharmaceutical sector to get accurate data and to help ensure ...
New medicines are developed every day to meet medical needs and improve quality of life and HPLC methods are widely used in R&D and QC pharmaceutical labs. Analytical methods establish acceptance ...
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