方案中应说明目的、范围、责、使用的仪侈和试剂以及分析方法、试验的设计和转移中使用的所有检验和/或方法据验证数据和检验方法,在转移方案中规定需对哪些项目进行确认(见1225)以及对接受结果的方法Thetransferacceptaneecriteri 24、a,whicharebasedonmethodperformaneeandstabilityandreleaseresults,ifavailable,shouldin...
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 ...
6、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 unit, also referred to as the sending unit), thus ensuring that the receiving unit has the procedural knowledge...
882〈1226〉 Verification of Compendial Procedures / General Information USP 35 terial to which the procedure is applied. Although complete 〈1226〉 VERIFICATION OF revalidation of a compendial method is not required to ver-ify the suitability of v a procedure v USP35 under actual condi-...
LUSP35used to evaluate acceptable outcomes of the transferexercise.The transfer acceptance criteria, which are based onmethod performance and historical data from stability andrelease results, if available, should include the comparabilitycriteria for results from all study sites. These criteria may be...
the transferring unit should the transfer protocol may include report forms to ensure provide training to the receiving unit, or the receiving unit consistent recording of results and to improve consistency between laboratories. This section should contain the addi- should run the procedures and identif...
mediate, and/or ingredient and product is critical in estab-Transfer Waiver lishing the quality of a finished dosage form. The transfer of analytical procedures (TAP), also referred to as method The conventional TAP may be omitted under certain cir-transfer, is the documented process that ...
1224 分析程序的转移 TRANSFER OFANALYTICAL PROCEDURES 1225 药典程序验证 VALIDATION OFCOMPENDIAL PROCEDURES 1226 药典程序确认 VERIFICATION OFCOMPENDIAL PROCEDURES 1227 药典条款中微生物回收率的验证 VALIDATION OFMICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES 1228 除热原法 DEPYROGENATION 1228.1 干热除热原法 DR...
–Contactprocesschemistsforspecificrequirements –DOE •MethodOptimization(ChemistryandGame) •MethodValidation(ChemistryandExpertise) –Identifypurposeofthemethod –Determineparameterstovalidate –Developvalidationprotocol –Generatedataandreport •MethodTransferand/orMethodVerification(ChemistryandWork) USPMonograph...
TRANSFER OF ANALYTICAL PROCEDURES 分析方法转移 V1225VALIDATION OF COMPENDIAL PROCEDURES 药典方法的验证 V1226VERIFICATION OF COMPENDIAL PROCEDURES 药典方法的确认 V1227VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES 从药物中回收微生物的验证 V 1229 STERILIZATION OF COMPENDIAL ARTICLES 药典灭菌过程 V...