欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
请问packaging material和packing material有什么区别呢？？？ §211.22 Responsibilities of quality control unit.(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company. (b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit. 99. Two comments suggested either deleting the reference in 211.22(b) to "packaging materials" as one of the articles tested in the quality control laboratory, or changing it to "packing materials," on the basis that the examination for suitability of such materials is more properly a function of the shipping department and relates solely to protective qualities to prevent mutilation or breakage of drug product containers. Breakage of containers can cause product adulteration and mutilation of containers, which may result in product misbranding. The protection of drug products from such mechanical damage is just as much a function of the maintenance of drug product quality as placing light-sensitive products in light-resistent containers or labeling a product with its proper name and an accurate statement of its potency. The Commissioner notes that primary responsibility for selecting specifications for packaging materials may be assigned to the shipping department of a firm. Under 211.22, the quality control unit is only responsible for testing and approving (or rejecting) packaging materials in accordance with these specifications. Therefore, no change is needed in the section. §211.103 Calculation of yield.Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall either be performed by one person and independently verified by a second person, or, if the yield is calculated by automated equipment under §211.68, be independently verified by one person. §211.25 Personnel qualifications.(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. | 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2017-8-3 19:15:01
置顶卡
变色卡
发表于 2017-8-3 21:41:26
就喜欢你发这样的文章。个人理解，Packageing material是包材，Packing material是包装物料。
楼主