[Code of Federal Regulations] [Title 21, Volume 4] [Revised as of April 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR211.1] [Page 120-122] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS --Table of Contents Subpart A_General Provisions Sec. 211.1 Scope. Subpart A_General Provisions Sec. 211.1 Scope. 211.3 Definitions. Subpart B_Organization and Personnel 211.22 Responsibilities of quality control unit. 211.25 Personnel qualifications. 211.28 Personnel responsibilities. 211.34 Consultants. Subpart C_Buildings and Facilities 211.42 Design and construction features. 211.44 Lighting. 211.46 Ventilation, air filtration, air heating and cooling. 211.48 Plumbing. 211.50 Sewage and refuse. 211.52 Washing and toilet facilities. 211.56 Sanitation. 211.58 Maintenance. Subpart D_Equipment 211.63 Equipment design, size, and location. 211.65 Equipment construction. 211.67 Equipment cleaning and maintenance. 211.68 Automatic, mechanical, and electronic equipment. 211.72 Filters. Subpart E_Control of Components and Drug Product Containers and Closures 211.80 General requirements. 211.82 Receipt and storage of untested components, drug product containers, and closures. 211.84 Testing and approval or rejection of components, drug product containers, and closures. 211.86 Use of approved components, drug product containers, and closures. 211.87 Retesting of approved components, drug product containers, and closures. 211.89 Rejected components, drug product containers, and closures. [[Page 121]] 211.94 Drug product containers and closures. Subpart F_Production and Process Controls 211.100 Written procedures; deviations. 211.101 Charge-in of components. 211.103 Calculation of yield. 211.105 Equipment identification. 211.110 Sampling and testing of in-process materials and drug products. 211.111 Time limitations on production. 211.113 Control of microbiological contamination. 211.115 Reproccessing. Subpart G_Packaging and Labeling Control 211.122 Materials examination and usage criteria. 211.125 Labeling issuance. 211.130 Packaging and labeling operations. 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.134 Drug product inspection. 211.137 Expiration dating. Subpart H_Holding and Distribution 211.142 Warehousing procedures. 211.150 Distribution procedures. Subpart I_Laboratory Controls 211.160 General requirements. 211.165 Testing and release for distribution. 211.166 Stability testing. 211.167 Special testing requirements. 211.170 Reserve samples. 211.173 Laboratory animals. 211.176 Penicillin contamination. Subpart J_Records and Reports 211.180 General requirements. 211.182 Equipment cleaning and use log. 211.184 Component, drug product container, closure, and labeling records. 211.186 Master production and control records. 211.188 Batch production and control records. 211.192 Production record review. 211.194 Laboratory records. 211.196 Distribution records. 211.198 Complaint files. Subpart K_Returned and Salvaged Drug Products 211.204 Returned drug products. 211.208 Drug product salvaging. Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374. Effective Date Note: At 69 FR 29828, May 25, 2004, the authority citation for part 211 was revised, effective May 25, 2005. For the convenience of the user the revised text follows: Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted. (a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals. (b) The current good manufacturing practice regulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part. (c) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice. [43 FR 45077, Sept. 29, 1978, as amended at 62 FR 66522, Dec. 19, 1997] Effective Date Note: At 69 FR 29828, May 25, 2004, Sec. 211.1 was amended by revising paragraph (b), effective May 25, 2005. For the convenience of the user the revised text follows: [[Page 122]] Sec. 211.1 Scope. * * * * * (b) The current good manufacturing practice regulations in this chapter as they pertain to drug products; in parts 600 through 680 of this chapter, as they pertain to drugs that are also biological products for human use; and in part 1271 of this chapter, as they are applicable to drugs that are also human cells, tissues, and cellular and tissue- based products (HCT/Ps) and that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act); supplement and do not supersede the regulations in this part unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general. * * * * *