cgmp--currentgoodmanufacturingpractice(中英文对照版).docx,A A ?总则 Subpart A-General Provisions 211. 1范围 § 211.1 Scope (a) The regulations in this part contain the minimum curre nt good manu facturi ng practice for preparati on of drug products for a
CGMP--Current-Good-Manufacturing-Practice(中英文对照版).doc,§ 211.28 Personnel responsibilities. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. P
Training in current good manufacturing 保证雇员熟悉现行 practice shall be conducted by qualified GMP(CGMP)对他们 individuals on a continuing basis and with 的要求。 sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. b) 负责监督药品的生产、 (b) ...
under current good manufacturing practice. 产、加工、包装&贮存。 § 211.3 Definitions. 211.3 定义 The definitions set forth in §210.3 of this chapter 本章 211.3 中的定义使用 apply in this part. 于本部分。 good manufacturing practice ( GMP ) 良好的生产管理规范 over-the-counter (OTC) 人用非...
CGMP--CurrentGoodManufacturingPractice(中英文对照版) Subpart A-General Provisions ? 211.1 Scope The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals. The current good manufacturing practice regulations...
significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century, to enhance and modernize the regulation of pharmaceutical manufacturing and product quality — to bring a 21st century focus to this critical FDA responsibility. The initiative, which this final ...
§120.5 Current good manufacturing practice. Part 110 of this chapter applies in determining whether the facilities, methods, practices, and controls used to process juice are safe, and whether the food has been processed under sanitary conditions....
Summary This chapter contains sections titled: Historical Perspective Current Good Manufacturing Practice Rationale Current Good Manufacturing Practice Violations Process Control Imperative Future Initiatives Summary Disclaimer References Appendix 64-1. Top 10 Citations Observed in FDA Inspections Conducted in ...
§ 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities, methods, practices, and controls used to process fish and fishery products are safe, and whether these products have been processed under sanitary conditions. ...
PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL Sec. 210.1 Status of current good manufacturing practice regulations. (a)The regulations set forth in this part and in parts211225,and226of this chapter contain the minimum current good...