USP1224分析方法转移(USP草案))VIP免费

BRIEFING 1224 Transfer of Analytical Procedures. 分析方法转移 After publication of the Stimu li article “Transfer of Analytical Procedures: A Proposal for a New General Information Chapter” in PF 35(5) [Sept.–Oct. 2009] and based on comments received, the General Chapters— Physical Analysis Expert Committee proposes this new general information chapter. The proposed chapter is intended to become one of a series of general chapters that provides guidance for generation of data (i.e., qualification, validation, and verification) in support of compendial analytical procedures. While the concepts presented in the proposed chapter are related to the verification processes described in general chapter Verification of Compendial Procedu res 1226 , the verification process is focused primarily on the drug product and associated matrix effects or other potential interference issues. In contrast, the procedure-transfer process focuses on qualifying the receiving laboratory to perform an analytical procedure that was developed and validated in another laboratory. (GCPA: H. Pappa.) Correspondence Number— C74516 分析方法转移程序的目的是为了确认接收的实验室是否可以进行在另一个实验室中研发并经过验证的检验方法。 Comment deadline: March 31, 2011 Add the follow ing: 1224 TRANSFER OF ANALYTICAL PROCEDURES 分析方法转移程序 INTRODUCTION 前言 Testing to the specification of an ancillary material, intermediate, and/or ingredient and product is critical in establishing the quality of a finished dosage form. The transfer of analytical procedures (TAP), also referred to as method transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring u...