5、d if such approach satisfies the requirements of the applicable statute, regulations, or both.本指南由FDA的CDER的达标办公室/制造、产品、质量分部起草,本指南阐明了机构关于评估00S检验结果的现行的想法。它不会创造或赠与任何人任何权力,也不会约束 FDA 或公众。如果其他可 选择的相接近的指南能满足适用...
本指南由FDA^CDE的达标办公室/制造、产品、质量分部起草,本指南说明了机构关于评估 OO检验结果的现行的想法。它不会创造或赠与任何人任何权力,也不会约束 FD域公众。如果其他可选择的相接近的指南能满足适用的法令和法规的要求,也可以使用。 GUIDANCE FOR INDUST1RY Investigating Out of Specification (OOS) Test ...
International Journal of Generic Drugs First Issued Sept 1998 DRAFT GUIDELINES GUIDANCE FOR INDUSTRY OUT-OF-SPECIFICATION Draft - Not for Implementation TEST RESULTS ‘…An Out-of-Specification Test Result is not necessary a product failure - and needs to be qualified … FDA's NEW OOS GUIDANCE ...
EudraLex - Volume 4 Good Manufacturing Practice (GMP) Guidelines, Chapter 6 Quality Control (European Commission, Brussels, Belgium, 2014). Inspection of Pharmaceutical Quality Control Laboratories (Food and Drug Administration, Rockville, Maryland, 1993). FDA Compliance Program Guide CPG 7346.832 ...
4、eateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Analternativeapproachmaybeusedifsuchapproachsatisfiestherequirementsoftheapplicablestatute,regulations,orboth.本指南由FDA勺CDE的达标办公室/制造、产品、质量分部起草,本指南说明了机构关于评估00检验结果的现行的想法。它不会创造或赠与任何...