Transfer of Analytical Method's Pharmacopoeias for Assay of Pharmacokinetic In-vitro and Impurities Profile Based on Different Concepts
DOI:
https://doi.org/10.59846/ajbas.v3i1.637Keywords:
Transfer , re validation , Method’s PharmacopeiasAbstract
This paper was carried out to give requirements , criteria and protocol for a transfer (re-validation/partial validation) of pharmacopeia analytical methods based on European Pharmacopeia (EP) and United State Pharmacopeia (USP) requirements. The different steps in a transfer of analytical methods for quantification of active ingredient (assay), impurities profile of drugs sub-stance and finish products and assay of drug dissolution assay (pharmacokinetic in-vitro) were explored, discussed and illustrated with a examples. The recommendations and requirements for this purpose were described in some international guidelines that due to the lack details of protocol. The authors showed both protocols with aid protocol of International Conference harmonization (ICH) and simple statistical process for management of data obtained of transfer of method's pharmacopeia. These analytical methods need verification of system suitability (revalidation or partial validation) , the method's pharmacopeia (reference method) for quality control of drug substance isn’t formal partial validation required based on EP concept, while these methods for quality control of drug product need revalidation based on EP and USP requirement. In conclusion the transfer and application of method's pharmacopeias by pharmaceutical manufactures require system suitability test and partial revalidation to assure the report of routine analysis results and reports.
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