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Regulations
Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
Subpart B: Organization and Personnel
21 CFR 211.28 - Personnel responsibilities.
21 CFR 211.28(a) - (a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall...
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21 CFR 211.28(c) - (c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings a...
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21 CFR 211.34 - Consultants.
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21 CFR 211.25 - Personnel qualifications.
21 CFR 211.25(a) - (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product sha...
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21 CFR 211.25(b) - (b) Each person responsible for supervising the manufacture, processing, packing, or holding of a...
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21 CFR 211.25(c) - (c) There shall be an adequate number of qualified personnel to perform and supervise the manufac...
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21 CFR 211.22 - Responsibilities of quality control unit.
21 CFR 211.22(d) - (d) The responsibilities and procedures applicable to the quality control unit shall be in writin...
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21 CFR 211.22(a) - (a) There shall be a quality control unit that shall have the responsibility and authority to app...
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21 CFR 211.22(b) - (b) Adequate laboratory facilities for the testing and approval (or rejection) of components, dru...
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21 CFR 211.22(c) - (c) The quality control unit shall have the responsibility for approving or rejecting all procedu...
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21 CFR 211.22 - Responsibilities of quality control unit.
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Subpart C: Buildings and Facilities
21 CFR 211.56 - Sanitation.
21 CFR 211.56(b) - (b) There shall be written procedures assigning responsibility for sanitation and describing in s...
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21 CFR 211.56(a) - (a) Any building used in the manufacture, processing, packing, or holding of a drug product shall...
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21 CFR 211.46 - Ventilation, air filtration, air heating and cooling.
21 CFR 211.46(c) - (c) Air filtration systems, including prefilters and particulate matter air filters, shall be use...
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21 CFR 211.58 - Maintenance.
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21 CFR 211.42 - Design and construction features.
21 CFR 211.42(b) - (b) Any such building shall have adequate space for the orderly placement of equipment and materi...
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21 CFR 211.42(d) - (d) Operations relating to the manufacture, processing, and packing of penicillin shall be perfor...
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21 CFR 211.42(a) - (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug ...
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21 CFR 211.42 - Design and construction features.
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21 CFR 211.42(c) - (c) Operations shall be performed within specifically defined areas of adequate size
21 CFR 211.42(c) - (c) Operations shall be performed within specifically defined areas of adequate size
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21 CFR 211.42(c)(5) - (5) Manufacturing and processing operations;
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21 CFR 211.42(c)(10) - (10) Aseptic processing, which includes as appropriate:
21 CFR 211.42(c)(10) - (10) Aseptic processing, which includes as appropriate:
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21 CFR 211.42(c)(10)(i) - (i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable;
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21 CFR 211.42(c)(10)(ii) - (ii) Temperature and humidity controls;
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21 CFR 211.42(c)(10)(iii) - (iii) An air supply filtered through high-efficiency particulate air filters under positive press...
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21 CFR 211.42(c)(10)(iv) - (iv) A system for monitoring environmental conditions;
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21 CFR 211.42(c)(10)(v) - (v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
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21 CFR 211.42(c)(10)(vi) - (vi) A system for maintaining any equipment used to control the aseptic conditions.
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Subpart D: Equipment
21 CFR 211.63 - Equipment design, size, and location.
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21 CFR 211.65 - Equipment construction.
21 CFR 211.65(a) - (a) Equipment shall be constructed so that surfaces that contact components, in-process materials...
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21 CFR 211.67 - Equipment cleaning and maintenance.
21 CFR 211.67(b) - (b) Written procedures shall be established and followed for cleaning and maintenance of equipmen...
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21 CFR 211.67(c) - (c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in §§...
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21 CFR 211.67(a) - (a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of th...
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21 CFR 211.68 - Automatic, mechanical, and electronic equipment.
21 CFR 211.68(b) - (b) Appropriate controls shall be exercised over computer or related systems to assure that chang...
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21 CFR 211.68(a) - (a) Automatic, mechanical, or electronic equipment or other types of equipment, including compute...
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21 CFR 211.68 - Automatic, mechanical, and electronic equipment.
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Subpart E: Control of Components and Drug Product Containers and Closures
21 CFR 211.87 - Retesting of approved components, drug product containers, and closures.
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21 CFR 211.80 - General requirements.
21 CFR 211.80(d) - (d) Each container or grouping of containers for components or drug product containers, or closur...
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21 CFR 211.80(a) - (a) There shall be written procedures describing in sufficient detail the receipt, identification...
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21 CFR 211.80 - General requirements.
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21 CFR 211.94 - Drug product containers and closures.
21 CFR 211.94(b) - (b) Container closure systems shall provide adequate protection against foreseeable external fact...
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21 CFR 211.94(c) - (c) Drug product containers and closures shall be clean and, where indicated by the nature of the...
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21 CFR 211.94(d) - (d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, s...
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21 CFR 211.94 - Drug product containers and closures.
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21 CFR 211.84 - Testing and approval or rejection of components, drug product containers, and closures.
21 CFR 211.84(a) - (a) Each lot of components, drug product containers, and closures shall be withheld from use unti...
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21 CFR 211.84(e) - (e) Any lot of components, drug product containers, or closures that meets the appropriate writte...
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21 CFR 211.84(b) - (b) Representative samples of each shipment of each lot shall be collected for testing or examina...
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21 CFR 211.84 - Testing and approval or rejection of components, drug product containers, and closures.
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21 CFR 211.84(d) - (d) Samples shall be examined and tested as follows:
21 CFR 211.84(d)(1) - (1) At least one test shall be conducted to verify the identity of each component of a drug produ...
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21 CFR 211.84(d)(2) - (2) Each component shall be tested for conformity with all appropriate written specifications for...
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21 CFR 211.84(d)(3) - (3) Containers and closures shall be tested for conformity with all appropriate written specifica...
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21 CFR 211.84(d)(6) - (6) Each lot of a component, drug product container, or closure with potential for microbiologica...
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Subpart F: Production and Process Controls
21 CFR 211.100 - Written procedures; deviations.
21 CFR 211.100(a) - (a) There shall be written procedures for production and process control designed to assure that ...
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21 CFR 211.100(b) - (b) Written production and process control procedures shall be followed in the execution of the v...
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21 CFR 211.100 - Written procedures; deviations.
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21 CFR 211.101 - Charge-in of components.
21 CFR 211.101(a) - (a) The batch shall be formulated with the intent to provide not less than 100 percent of the lab...
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21 CFR 211.101 - Charge-in of components.
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21 CFR 211.113 - Control of microbiological contamination.
21 CFR 211.113(a) - (a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug prod...
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21 CFR 211.113(b) - (b) Appropriate written procedures, designed to prevent microbiological contamination of drug pro...
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21 CFR 211.110 - Sampling and testing of in-process materials and drug products.
21 CFR 211.110(a) - (a) To assure batch uniformity and integrity of drug products, written procedures shall be establ...
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21 CFR 211.110(c) - (c) In-process materials shall be tested for identity, strength, quality, and purity as appropria...
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21 CFR 211.110(d) - (d) Rejected in-process materials shall be identified and controlled under a quarantine system de...
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21 CFR 211.110(b) - (b) Valid in-process specifications for such characteristics shall be consistent with drug produc...
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21 CFR 211.111 - Time limitations on production.
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Subpart G: Packaging and Labeling Control
21 CFR 211.137 - Expiration dating.
21 CFR 211.137(a) - (a) To assure that a drug product meets applicable standards of identity, strength, quality, and ...
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21 CFR 211.137 - Expiration dating.
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21 CFR 211.125 - Labeling issuance.
21 CFR 211.125(f) - (f) Procedures shall be written describing in sufficient detail the control procedures employed f...
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21 CFR 211.125(b) - (b) Labeling materials issued for a batch shall be carefully examined for identity and conformity...
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21 CFR 211.125(a) - (a) Strict control shall be exercised over labeling issued for use in drug product labeling opera...
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21 CFR 211.130 - Packaging and labeling operations.
21 CFR 211.130(a) - (a) Prevention of mixups and cross-contamination by physical or spatial separation from operation...
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21 CFR 211.130(e) - (e) Inspection of the packaging and labeling facilities immediately before use to assure that all...
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21 CFR 211.130(c) - (c) Identification of the drug product with a lot or control number that permits determination of...
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21 CFR 211.130(d) - (d) Examination of packaging and labeling materials for suitability and correctness before packag...
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21 CFR 211.130 - Packaging and labeling operations.
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Subpart H: Holding and Distribution
21 CFR 211.142 - Warehousing procedures.
21 CFR 211.142(b) - (b) Storage of drug products under appropriate conditions of temperature, humidity, and light so ...
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21 CFR 211.150 - Distribution procedures.
21 CFR 211.150(b) - (b) A system by which the distribution of each lot of drug product can be readily determined to f...
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Subpart I: Laboratory Controls
21 CFR 211.176 - Penicillin contamination.
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21 CFR 211.165 - Testing and release for distribution.
21 CFR 211.165(d) - (d) Acceptance criteria for the sampling and testing conducted by the quality control unit shall ...
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21 CFR 211.165(b) - (b) There shall be appropriate laboratory testing, as necessary, of each batch of drug product re...
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21 CFR 211.165(f) - (f) Drug products failing to meet established standards or specifications and any other relevant ...
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21 CFR 211.165(a) - (a) For each batch of drug product, there shall be appropriate laboratory determination of satisf...
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21 CFR 211.165(e) - (e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the f...
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21 CFR 211.166 - Stability testing.
21 CFR 211.166(b) - (b) An adequate number of batches of each drug product shall be tested to determine an appropriat...
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21 CFR 211.166 - Stability testing.
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21 CFR 211.166(a) - (a) There shall be a written testing program designed to assess the stability characteristics of ...
21 CFR 211.166(a) - (a) There shall be a written testing program designed to assess the stability characteristics of ...
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21 CFR 211.166(a)(4) - (4) Testing of the drug product in the same container-closure system as that in which the drug pr...
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21 CFR 211.170 - Reserve samples.
21 CFR 211.170(b) - (b) An appropriately identified reserve sample that is representative of each lot or batch of dru...
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21 CFR 211.170(a) - (a) An appropriately identified reserve sample that is representative of each lot in each shipmen...
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21 CFR 211.160 - General requirements.
21 CFR 211.160(a) - (a) The establishment of any specifications, standards, sampling plans, test procedures, or other...
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21 CFR 211.160 - General requirements.
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21 CFR 211.160(b) - (b) Laboratory controls shall include the establishment of scientifically sound and appropriate s...
21 CFR 211.160(b) - (b) Laboratory controls shall include the establishment of scientifically sound and appropriate s...
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21 CFR 211.160(b)(3) - (3) Determination of conformance to written descriptions of sampling procedures and appropriate s...
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21 CFR 211.160(b)(4) - (4) The calibration of instruments, apparatus, gauges, and recording devices at suitable interval...
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21 CFR 211.167 - Special testing requirements.
21 CFR 211.167(a) - (a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be a...
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Subpart J: Records and Reports
21 CFR 211.182 - Equipment cleaning and use log.
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21 CFR 211.192 - Production record review.
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21 CFR 211.186 - Master production and control records.
21 CFR 211.186(a) - (a) To assure uniformity from batch to batch, master production and control records for each drug...
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21 CFR 211.198 - Complaint files.
21 CFR 211.198(a) - (a) Written procedures describing the handling of all written and oral complaints regarding a dru...
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21 CFR 211.198 - Complaint files.
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21 CFR 211.194 - Laboratory records.
21 CFR 211.194(c) - (c) Complete records shall be maintained of any testing and standardization of laboratory referen...
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21 CFR 211.194 - Laboratory records.
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21 CFR 211.194(a) - (a) Laboratory records shall include complete data derived from all tests necessary to assure com...
21 CFR 211.194(a) - (a) Laboratory records shall include complete data derived from all tests necessary to assure com...
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21 CFR 211.194(a)(2) - (2) A statement of each method used in the testing of the sample. The statement shall indicate th...
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21 CFR 211.196 - Distribution records.
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21 CFR 211.180 - General requirements.
21 CFR 211.180(c) - (c) All records required under this part, or copies of such records, shall be readily available f...
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21 CFR 211.180(e) - (e) Written records required by this part shall be maintained so that data therein can be used fo...
21 CFR 211.180(e) - (e) Written records required by this part shall be maintained so that data therein can be used fo...
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21 CFR 211.180(e)(2) - (2) A review of complaints, recalls, returned or salvaged drug products, and investigations condu...
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21 CFR 211.188 - Batch production and control records.
21 CFR 211.188 - Batch production and control records.
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21 CFR 211.188(b) - (b) Documentation that each significant step in the manufacture, processing, packing, or holding ...
21 CFR 211.188(b) - (b) Documentation that each significant step in the manufacture, processing, packing, or holding ...
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21 CFR 211.188(b)(3) - (3) Specific identification of each batch of component or in-process material used;
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Subpart K: Returned and Salvaged Drug Products
21 CFR 211.208 - Drug product salvaging.
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Part 212: Current Good Manufacturing Practice for Positron Emission Tomography Drugs
Subpart C: Quality Assurance
21 CFR 212.20 - What activities must I perform to ensure drug quality?
21 CFR 212.20(d) - (d) Production records. You must review production records to determine whether errors have occu...
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21 CFR 212.20(c) - (c) Specifications and processes. You must approve or reject, before implementation, any initial...
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Subpart D: Facilities and Equipment
21 CFR 212.30 - What requirements must my facilities and equipment meet?
21 CFR 212.30(a) - (a) Facilities. You must provide adequate facilities to ensure the orderly handling of materials...
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Subpart G: Laboratory Controls
21 CFR 212.60 - What requirements apply to the laboratories where I test components, in-process materials, and fi...
21 CFR 212.60(a) - (a) Testing procedures. Each laboratory used to conduct testing of components, in-process materi...
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Part 310: New Drugs
Subpart D: Records and Reports
21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human ...
21 CFR 310.305(c) - (c) Reporting requirements
21 CFR 310.305(c)(2) - (2) Postmarketing 15-day “Alert reports”—followup. Each person identified in paragraph (c)(1)(i)...
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Part 312: Investigational New Drug Application
Subpart A: General Provisions
21 CFR 312.7 - Promotion of investigational drugs.
21 CFR 312.7(b) - (b) Commercial distribution of an investigational new drug. A sponsor or investigator shall not ...
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21 CFR 312.7(a) - (a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on...
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21 CFR 312.7 - Promotion of investigational drugs.
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Subpart B: Investigational New Drug Application (IND)
21 CFR 312.20 - Requirement for an IND.
21 CFR 312.20(a) - (a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigati...
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Subpart D: Responsibilities of Sponsors and Investigators
21 CFR 312.69 - Handling of controlled substances.
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21 CFR 312.52 - Transfer of obligations to a contract research organization.
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21 CFR 312.60 - General responsibilities of investigators.
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21 CFR 312.62 - Investigator recordkeeping and record retention.
21 CFR 312.62(b) - (b) Case histories. An investigator is required to prepare and maintain adequate and accurate ca...
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21 CFR 312.62(a) - (a) Disposition of drug. An investigator is required to maintain adequate records of the disposi...
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21 CFR 312.62(c) - (c) Record retention. An investigator shall retain records required to be maintained under this ...
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21 CFR 312.62 - Investigator recordkeeping and record retention.
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21 CFR 312.66 - Assurance of IRB review.
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21 CFR 312.50 - General responsibilities of sponsors.
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21 CFR 312.57 - Recordkeeping and record retention.
21 CFR 312.57(a) - (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition...
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Part 314: Applications for FDA Approval to Market a New Drug
Subpart B: Applications
21 CFR 314.81 - Other postmarketing reports.
21 CFR 314.81 - Other postmarketing reports.
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21 CFR 314.81(b) - (b) Reporting requirements. The applicant shall submit to the Food and Drug Administration at th...
21 CFR 314.81(b)(1) - (1) NDA—Field alert report. The applicant shall submit information of the following kinds about ...
21 CFR 314.81(b)(1)(i) - (i) Information concerning any incident that causes the drug product or its labeling to be mistak...
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21 CFR 314.81(b)(1)(ii) - (ii) Information concerning any bacteriological contamination, or any significant chemical, physi...
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21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.
21 CFR 314.80(b) - (b) Review of adverse drug experiences. Each applicant having an approved application under § 31...
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21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.
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21 CFR 314.80(c) - (c) Reporting requirements
21 CFR 314.80(c)(1) - (1)
21 CFR 314.80(c)(1)(i) - (i) Postmarketing 15-day “Alert reports”. The applicant must report each adverse drug experience...
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21 CFR 314.80(c)(1)(ii) - (ii) Postmarketing 15-day “Alert reports”—followup. The applicant must promptly investigate all ...
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