Transfer of Analytical Procedures (Review)

• Main Authors: Yu. A. Starchak, M. V. Gavrilin, N. V. Shineva
• Format: Article
• Language: Russian
• Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2020-08-01
• Series: Разработка и регистрация лекарственных средств
• Subjects: transfer; transfer of analytical procedures; state pharmacopoeia; comparative study; transfer protocol; transfer report
• Online Access: https://www.pharmjournal.ru/jour/article/view/786

Introduction. This article reviews main steps of the transfer of analytical procedures following the recommendations of the Russian and foreign regulatory bodies. Each step provides thorough evaluation of an analytical procedure, checks its current validation status and readiness of the receiving laboratory. Each step of the process is crucial for a reliable transfer. The article contains examples of formatting of analytical procedures to be revalidated, characteristics of test samples, reference standards of impurities. The authors described procedures to be transferred depending on the dosage form.Text. The aim of this article is to review possible types of the transfer, including a transfer waiver, and main components of a transfer protocol following the information from the Russian and foreign literature sources.Conclusion. Reliability and reproducibility of analytical method data are crucial as they form the basis for a decision-making process. Therefore a procedure should be capable of producing consistent data.