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Latest From Joanne Eglovitch
US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.
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.
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.
USP is looking to develop standards for rapid sterility tests for drugs and biologics. Existing growth-based compendial methods are too slow to obtain results before cell and gene therapies, positron emission tomography drugs and sterile compounded drugs must be used. Quicker methods would improve efficiency in the manufacture of other drugs as well. Detection limits could be orders of magnitude higher without compromising the ability to detect infectious levels of microbiological organisms.
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.