Drug Makers Urged To Collect Own Excipient Metals Data To Comply With ICH Q3D
While leveraging published data may help pharmaceutical manufacturers understand the general risks of using excipients with known elemental impurities, it is less helpful in understanding specific risks.
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A pharmaceutical industry official said while it is not too late, manufacturers that have not yet started risk assessments to comply with ICH Q3D for legacy products need to get busy. Official also advised that good risk assessments should make it easier to comply and reduce the need to retest products if new metals are introduced into the manufacturing process.
ICH updates progress made on quality guidelines; EMA talks combination products; UK MHRA report sheds light on GMP deficiencies; MHRA official describes compliance escalation; FDA guides microbiology reviewers through Common Technical Document; FDA OKs reliance on non-USP compendia in applications.
The pharmaceutical industry is developing an excipient database to better enable industry to conduct risk assessments set out in the ICH Q3D guideline.