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Analytical chemistry labs may get all the attention when it comes to the search for data integrity failures, but FDA and industry experts say not to overlook the possibility of such failures in microbiology labs. Just keep in mind that the highly manual operations in these labs calls for a different approach to auditing.
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Lawsuit over infant's death and warning letter over recurring contamination underscore the importance of screening for Burkholderia cepacia and when found, removing the microorganism from pharmaceutical manufacturing processes.
ICH Q3D went into effect in June 2016 for new drugs, but so far doesn't seem to have completely resolved worries about the presence of elemental impurities in drug products.
After a proposal for harmonized process validation guidance didn't make the cut at ICH, PhRMA and US FDA proponents are making the case to a broader audience. Current ICH guidance is unclear, and regional guidance is conflicting, they told the ISPE annual meeting.
In addition to AZX Sport lip balms and hand sanitizers, other topical consumer drugs often considered personal care or cosmetic products outside the US were added in the latest update to FDA's list of import alerts for "detention without physical examination of drugs from firms which have not met drug GMPs."
It remains uncertain whether a legal review by the European Commission that since June has delayed public consultation of draft ICH Q12 post-approval changes guideline can be resolved during this week's ICH meeting in Geneva.
Manufacturers should create internal databases on elemental impurities for product risk assessments and not depend on suppliers to provide this information, which is called for under ICH Q3D. So far risk assessments have shown that most products are significantly below elemental impurity thresholds. Pharmaceutical manufacturers must complete assessments of legacy drugs by Dec. 31.
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