保健品GMP良规范操作.docVIP

PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 食品与药物管理局 膳食补充剂生产、包装、标签粘贴、保存现行生产质量管理规范 21 CFR 111部分 111部分-膳食补充剂生产、包装、标签粘贴、保存现行生产质量管理规范 Contents Subpart A—General Provisions §?111.1???Who is subject to this part?§?111.3???What definitions apply to this part?§?111.5???Do other statutory provisions and regulations apply? Subpart B—Personnel §?111.8???What are the requirements under this subpart B for written procedures?§?111.10???What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?§?111.12???What personnel qualification requirements apply?§?111.13???What supervisor requirements apply?§?111.14???Under this subpart B, what records must you make and keep? Subpart C—Physical Plant and Grounds §?111.15???What sanitation requirements apply to your physical plant and grounds?§?111.16???What are the requirements under this subpart C for written procedures?§?111.20???What design and construction requirements apply to your physical plant?§?111.23???Under this subpart C, what records must you make and keep? Subpart D—Equipment and Utensils §?111.25???What are the requirements under this subpart D for written procedures?§?111.27???What requirements apply to the equipment and utensils that you use?§?111.30???What requirements apply to automated, mechanical, or electronic equipment?§?111.35???Under this subpart D, what records must you make and keep? Subpart E—Requirement to Establish a Production and Process Control System §?111.55???What are the requirements to implement a production and process control system?§?111.60???What are the design requirements for the production and process control system?§?111.65???What are the requirements for quality control operations?§?111.70???What specifications must you establish?§?111.73???What is your responsibility for determining whether established specifications are met?