FDA has published final guidance documents regarding validation and development of analytical procedures. On March 7, 2024, FDA published two final guidance documents regarding analytical procedures ...
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 ...
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 ...
Approved by the Royal Society of Chemistry for purposes of continuing professional development (CPD). The course will provide you with the requisite scientific knowledge and understanding of ...
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 ...
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