11.4. Where activities are outsourced tocontract facilities, the contract must then clearly state, inter alia, theresponsibilities of each party, compliance with GMP or of this guideline, andthat the product(s) to be manufactured or controlled are intended for use inclinical trials. Close cooperat...
• information on scale-up activities: process optimization, statistical optimization of critical process parameters, critical quality attributes, pilot report and/or information on pilot-scale development activities indicating the number and dis...
• information or report on full-scale development activities, indicating the number and disposition of batches manufactured, and deviation and change control (sometimes referred to as change management) reports which led to the current manufacturing process; 有关全批量开发活动的信息或报告,说明生产的...
Medicinalproductsofbiologicaloriginmanufacturedbytheseprocedures includeallergens,antigens,vaccines,certainhormones,cytokines, monoclonalantibodies(mAbs),enzymes,animalimmunesera,productsof fermentation(includingproductsderivedfromrDNA),biological diagnosticreagentsforinvivouseandadvancedtherapymedicinal ...
15.13. Amaster formula, containing the relevant information, should be available forthe product and batch size to be manufactured. 应有包含适用于所生产产品和批量大小相关信息的主配方。 15.14. Packaging instructions should exist for theproducts to be packed.待包装的产品应有包装说明。 15.15. Abatch pr...
It is by design and validation that a manufacturer can establish condence that the manufactured products will consistently meet their product speci c 8、ations. 工艺和系统的验证是实现上述目标的基础之一。通过对生产的设计和验证,可使生产出的产品持续符合标准,并建立一定的置信区间。Documentation associated...
3.1. This guideline is applicable to research and development facilities of products manufactured by chemical synthesis, extraction, cell culture or fermentation, by recovery from natural sources, or by any combination of these processes. ...
3.1. Thisguideline is applicable to research and development facilities of productsmanufactured by chemical synthesis, extraction, cell culture or fermentation,by recovery from natural sources, or by any combination of these processes. Itfurther covers development of procedures and processes intended ...
maximum safe carryover (MSC). The maximum amount of carryover of a residual process residue (API, cleaning agent, degradant, and so forth) into the next product manufactured without presenting an appreciable health risk to patients.. 最大安全残留(MSC):残留物(API、清洁剂、降解剂等)的最大残留...
manufacture and that the goods so manufactured are marketable as new goods, known to the market, lies on the revenue and the same has not been discharged in the present case. To support the contention, reliance was placed on Lalji