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21 Code of Federal Regulations Parts 210 and 211 Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210.1 Status of current good manufacturing practice regulations. 210.2 Applicability of current good manufacturing practice regulations. 210.3 Definitions. AUTHORITY: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374). SOURCE: 43 FR 45076, Sept. 29, 1978, unless otherwise noted. PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart A - General Provisions 211.1 Scope 211.3 Definitions Subpart B - Organization and Personnel 211.22 Responsibiliti...

 INTRODUCTION   The purpose of this guidance is to clarify the role of data integrity in current good manufacturing  practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers  Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of  Drugs; General; part 211 covers Current Good Manufacturing Practice for Finished  Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron  Emission Tomography Drugs. This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements. FDA expects that data be reliable and accurate (see the “Background” section). CGMP  regulations and guidance allow for flexible and risk-based strategies to prevent and detect data  integrity issues. Firms should implement meaningful and effective strategies to manage their data  integrity risks based upon their proc...