Citations within the context of their regulations

Review the enforcement history for every citation given out with the Pharmaceutical sector.

21 CFR 211.22(b) - (b) Adequate laboratory facilities for the testing and approval (or rejection) of components, dru...

21 CFR 211.22(d) - (d) The responsibilities and procedures applicable to the quality control unit shall be in writin...

21 CFR 211.22(a) - (a) There shall be a quality control unit that shall have the responsibility and authority to app...

21 CFR 211.22(c) - (c) The quality control unit shall have the responsibility for approving or rejecting all procedu...

21 CFR 211.28(d) - (d) Any person shown at any time (either by medical examination or supervisory observation) to ha...

21 CFR 211.28(b) - (b) Personnel shall practice good sanitation and health habits.

21 CFR 211.28(a) - (a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall...

21 CFR 211.28(c) - (c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings a...

21 CFR 211.25(c) - (c) There shall be an adequate number of qualified personnel to perform and supervise the manufac...

21 CFR 211.25(b) - (b) Each person responsible for supervising the manufacture, processing, packing, or holding of a...

21 CFR 211.25(a) - (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product sha...

21 CFR 211.52 - Washing and toilet facilities.

21 CFR 211.46(a) - (a) Adequate ventilation shall be provided.

21 CFR 211.46(d) - (d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be comp...

21 CFR 211.46(b) - (b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temper...

21 CFR 211.46(c) - (c) Air filtration systems, including prefilters and particulate matter air filters, shall be use...

21 CFR 211.48(b) - (b) Drains shall be of adequate size and, where connected directly to a sewer, shall be provided ...

21 CFR 211.48(a) - (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free ...

21 CFR 211.50 - Sewage and refuse.

21 CFR 211.56(b) - (b) There shall be written procedures assigning responsibility for sanitation and describing in s...

21 CFR 211.56(a) - (a) Any building used in the manufacture, processing, packing, or holding of a drug product shall...

21 CFR 211.56(c) - (c) There shall be written procedures for use of suitable rodenticides, insecticides, fungicides,...

21 CFR 211.42(d) - (d) Operations relating to the manufacture, processing, and packing of penicillin shall be perfor...

21 CFR 211.42(a) - (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug ...

21 CFR 211.42(b) - (b) Any such building shall have adequate space for the orderly placement of equipment and materi...

21 CFR 211.42(c) - (c) Operations shall be performed within specifically defined areas of adequate size

21 CFR 211.42(c)(1) - (1) Receipt, identification, storage, and withholding from use of components, drug product contai...

21 CFR 211.42(c)(2) - (2) Holding rejected components, drug product containers, closures, and labeling before dispositi...

21 CFR 211.42(c)(3) - (3) Storage of released components, drug product containers, closures, and labeling;

21 CFR 211.42(c)(4) - (4) Storage of in-process materials;

21 CFR 211.42(c)(5) - (5) Manufacturing and processing operations;

21 CFR 211.42(c)(6) - (6) Packaging and labeling operations;

21 CFR 211.42(c)(7) - (7) Quarantine storage before release of drug products;

21 CFR 211.42(c)(8) - (8) Storage of drug products after release;

21 CFR 211.42(c)(9) - (9) Control and laboratory operations;

21 CFR 211.42(c)(10) - (10) Aseptic processing, which includes as appropriate:

21 CFR 211.42(c)(10)(i) - (i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable;

21 CFR 211.42(c)(10)(ii) - (ii) Temperature and humidity controls;

21 CFR 211.42(c)(10)(iii) - (iii) An air supply filtered through high-efficiency particulate air filters under positive press...

21 CFR 211.42(c)(10)(iv) - (iv) A system for monitoring environmental conditions;

21 CFR 211.42(c)(10)(v) - (v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;

21 CFR 211.42(c)(10)(vi) - (vi) A system for maintaining any equipment used to control the aseptic conditions.

21 CFR 211.65(a) - (a) Equipment shall be constructed so that surfaces that contact components, in-process materials...

21 CFR 211.65(b) - (b) Any substances required for operation, such as lubricants or coolants, shall not come into co...

21 CFR 211.63 - Equipment design, size, and location.

21 CFR 211.68(b) - (b) Appropriate controls shall be exercised over computer or related systems to assure that chang...

21 CFR 211.68(a) - (a) Automatic, mechanical, or electronic equipment or other types of equipment, including compute...

21 CFR 211.67(a) - (a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of th...

21 CFR 211.67(c) - (c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in §§...

21 CFR 211.67(b) - (b) Written procedures shall be established and followed for cleaning and maintenance of equipmen...

21 CFR 211.67(b)(1) - (1) Assignment of responsibility for cleaning and maintaining equipment;

21 CFR 211.67(b)(2) - (2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;

21 CFR 211.67(b)(3) - (3) A description in sufficient detail of the methods, equipment, and materials used in cleaning ...

21 CFR 211.67(b)(4) - (4) Removal or obliteration of previous batch identification;

21 CFR 211.67(b)(5) - (5) Protection of clean equipment from contamination prior to use;

21 CFR 211.67(b)(6) - (6) Inspection of equipment for cleanliness immediately before use.

21 CFR 211.80(b) - (b) Components and drug product containers and closures shall at all times be handled and stored ...

21 CFR 211.80(c) - (c) Bagged or boxed components of drug product containers, or closures shall be stored off the fl...

21 CFR 211.80(a) - (a) There shall be written procedures describing in sufficient detail the receipt, identification...

21 CFR 211.80(d) - (d) Each container or grouping of containers for components or drug product containers, or closur...

21 CFR 211.94(c) - (c) Drug product containers and closures shall be clean and, where indicated by the nature of the...

21 CFR 211.94(d) - (d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, s...

21 CFR 211.94(a) - (a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to ...

21 CFR 211.94(b) - (b) Container closure systems shall provide adequate protection against foreseeable external fact...

21 CFR 211.87 - Retesting of approved components, drug product containers, and closures.

21 CFR 211.89 - Rejected components, drug product containers, and closures.

21 CFR 211.84(e) - (e) Any lot of components, drug product containers, or closures that meets the appropriate writte...

21 CFR 211.84(a) - (a) Each lot of components, drug product containers, and closures shall be withheld from use unti...

21 CFR 211.84(b) - (b) Representative samples of each shipment of each lot shall be collected for testing or examina...

21 CFR 211.84(c)(1) - (1) The containers of components selected shall be cleaned when necessary in a manner to prevent ...

21 CFR 211.84(c)(2) - (2) The containers shall be opened, sampled, and resealed in a manner designed to prevent contami...

21 CFR 211.84(c)(3) - (3) Sterile equipment and aseptic sampling techniques shall be used when necessary.

21 CFR 211.84(c)(4) - (4) If it is necessary to sample a component from the top, middle, and bottom of its container, s...

21 CFR 211.84(c)(5) - (5) Sample containers shall be identified so that the following information can be determined: na...

21 CFR 211.84(c)(6) - (6) Containers from which samples have been taken shall be marked to show that samples have been ...

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...

21 CFR 211.84(d)(2) - (2) Each component shall be tested for conformity with all appropriate written specifications for...

21 CFR 211.84(d)(3) - (3) Containers and closures shall be tested for conformity with all appropriate written specifica...

21 CFR 211.84(d)(4) - (4) When appropriate, components shall be microscopically examined.

21 CFR 211.84(d)(5) - (5) Each lot of a component, drug product container, or closure that is liable to contamination w...

21 CFR 211.84(d)(6) - (6) Each lot of a component, drug product container, or closure with potential for microbiologica...

21 CFR 211.82(a) - (a) Upon receipt and before acceptance, each container or grouping of containers of components, d...

21 CFR 211.82(b) - (b) Components, drug product containers, and closures shall be stored under quarantine until they...

21 CFR 211.86 - Use of approved components, drug product containers, and closures.

21 CFR 211.100(a) - (a) There shall be written procedures for production and process control designed to assure that ...

21 CFR 211.100(b) - (b) Written production and process control procedures shall be followed in the execution of the v...

21 CFR 211.101(a) - (a) The batch shall be formulated with the intent to provide not less than 100 percent of the lab...

21 CFR 211.101(d) - (d) Each component shall either be added to the batch by one person and verified by a second pers...

21 CFR 211.101(b) - (b) Components for drug product manufacturing shall be weighed, measured, or subdivided as approp...

21 CFR 211.101(b)(1) - (1) Component name or item code;

21 CFR 211.101(b)(4) - (4) Batch for which component was dispensed, including its product name, strength, and lot number...

21 CFR 211.101(c) - (c) Weighing, measuring, or subdividing operations for components shall be adequately supervised

21 CFR 211.101(c)(1) - (1) The component was released by the quality control unit;

21 CFR 211.101(c)(3) - (3) The containers are properly identified. If the weighing, measuring, or subdividing operations...

21 CFR 211.105(a) - (a) All compounding and storage containers, processing lines, and major equipment used during the...

21 CFR 211.105(b) - (b) Major equipment shall be identified by a distinctive identification number or code that shall...

21 CFR 211.113(a) - (a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug prod...

21 CFR 211.113(b) - (b) Appropriate written procedures, designed to prevent microbiological contamination of drug pro...

21 CFR 211.110(c) - (c) In-process materials shall be tested for identity, strength, quality, and purity as appropria...

21 CFR 211.110(b) - (b) Valid in-process specifications for such characteristics shall be consistent with drug produc...

21 CFR 211.110(d) - (d) Rejected in-process materials shall be identified and controlled under a quarantine system de...

21 CFR 211.110(a) - (a) To assure batch uniformity and integrity of drug products, written procedures shall be establ...

21 CFR 211.110(a)(1) - (1) Tablet or capsule weight variation;

21 CFR 211.110(a)(3) - (3) Adequacy of mixing to assure uniformity and homogeneity;

21 CFR 211.110(a)(5) - (5) Clarity, completeness, or pH of solutions.

21 CFR 211.111 - Time limitations on production.

21 CFR 211.103 - Calculation of yield.

21 CFR 211.115(a) - (a) Written procedures shall be established and followed prescribing a system for reprocessing ba...

21 CFR 211.115(b) - (b) Reprocessing shall not be performed without the review and approval of the quality control un...

21 CFR 211.137(b) - (b) Expiration dates shall be related to any storage conditions stated on the labeling, as determ...

21 CFR 211.137(d) - (d) Expiration dates shall appear on labeling in accordance with the requirements of § 201.17 of ...

21 CFR 211.137(a) - (a) To assure that a drug product meets applicable standards of identity, strength, quality, and ...

21 CFR 211.130(b) - (b) Identification and handling of filled drug product containers that are set aside and held in ...

21 CFR 211.130(d) - (d) Examination of packaging and labeling materials for suitability and correctness before packag...

21 CFR 211.130(c) - (c) Identification of the drug product with a lot or control number that permits determination of...

21 CFR 211.130(e) - (e) Inspection of the packaging and labeling facilities immediately before use to assure that all...

21 CFR 211.130(a) - (a) Prevention of mixups and cross-contamination by physical or spatial separation from operation...

21 CFR 211.130 - Packaging and labeling operations.

21 CFR 211.122(d) - (d) Labels and other labeling materials for each different drug product, strength, dosage form, o...

21 CFR 211.122(f) - (f) Use of gang-printed labeling for different drug products, or different strengths or net conte...

21 CFR 211.122(e) - (e) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed.

21 CFR 211.122(h) - (h) Printing devices on, or associated with, manufacturing lines used to imprint labeling upon th...

21 CFR 211.122(c) - (c) Records shall be maintained for each shipment received of each different labeling and packagi...

21 CFR 211.122(b) - (b) Any labeling or packaging materials meeting appropriate written specifications may be approve...

21 CFR 211.122(a) - (a) There shall be written procedures describing in sufficient detail the receipt, identification...

21 CFR 211.122(g) - (g) If cut labeling is used for immediate container labels, individual unit cartons, or multiunit...

21 CFR 211.122(g)(2) - (2) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examina...

21 CFR 211.122(g)(3) - (3) Use of visual inspection to conduct a 100-percent examination for correct labeling during or ...

21 CFR 211.134(a) - (a) Packaged and labeled products shall be examined during finishing operations to provide assura...

21 CFR 211.134(c) - (c) Results of these examinations shall be recorded in the batch production or control records.

21 CFR 211.134(b) - (b) A representative sample of units shall be collected at the completion of finishing operations...

21 CFR 211.132(b)(1) - (1) Each manufacturer and packer who packages an OTC drug product (except a dermatological, denti...

21 CFR 211.125(e) - (e) Returned labeling shall be maintained and stored in a manner to prevent mixups and provide pr...

21 CFR 211.125(d) - (d) All excess labeling bearing lot or control numbers shall be destroyed.

21 CFR 211.125(c) - (c) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, ...

21 CFR 211.125(a) - (a) Strict control shall be exercised over labeling issued for use in drug product labeling opera...

21 CFR 211.125(f) - (f) Procedures shall be written describing in sufficient detail the control procedures employed f...

21 CFR 211.125(b) - (b) Labeling materials issued for a batch shall be carefully examined for identity and conformity...

21 CFR 211.142(a) - (a) Quarantine of drug products before release by the quality control unit.

21 CFR 211.142(b) - (b) Storage of drug products under appropriate conditions of temperature, humidity, and light so ...

21 CFR 211.142 - Warehousing 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...

21 CFR 211.150(a) - (a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviati...

21 CFR 211.150 - Distribution procedures.

21 CFR 211.160(a) - (a) The establishment of any specifications, standards, sampling plans, test procedures, or other...

21 CFR 211.160(b) - (b) Laboratory controls shall include the establishment of scientifically sound and appropriate s...

21 CFR 211.160(b)(1) - (1) Determination of conformity to applicable written specifications for the acceptance of each l...

21 CFR 211.160(b)(2) - (2) Determination of conformance to written specifications and a description of sampling and test...

21 CFR 211.160(b)(3) - (3) Determination of conformance to written descriptions of sampling procedures and appropriate s...

21 CFR 211.160(b)(4) - (4) The calibration of instruments, apparatus, gauges, and recording devices at suitable interval...

21 CFR 211.176 - Penicillin contamination.

21 CFR 211.165(d) - (d) Acceptance criteria for the sampling and testing conducted by the quality control unit shall ...

21 CFR 211.165(a) - (a) For each batch of drug product, there shall be appropriate laboratory determination of satisf...

21 CFR 211.165(c) - (c) Any sampling and testing plans shall be described in written procedures that shall include th...

21 CFR 211.165(f) - (f) Drug products failing to meet established standards or specifications and any other relevant ...

21 CFR 211.165(b) - (b) There shall be appropriate laboratory testing, as necessary, of each batch of drug product re...

21 CFR 211.165(e) - (e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the f...

21 CFR 211.167(a) - (a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be a...

21 CFR 211.167(c) - (c) For each batch of controlled-release dosage form, there shall be appropriate laboratory testi...

21 CFR 211.170(a) - (a) An appropriately identified reserve sample that is representative of each lot in each shipmen...

21 CFR 211.170(a)(1) - (1) For an active ingredient in a drug product other than those described in paragraphs (a) (2) a...

21 CFR 211.170(a)(3) - (3) For an active ingredient in an OTC drug product that is exempt from bearing an expiration dat...

21 CFR 211.170(b) - (b) An appropriately identified reserve sample that is representative of each lot or batch of dru...

21 CFR 211.170(b)(1) - (1) For a drug product other than those described in paragraphs (b) (2) and (3) of this section, ...

21 CFR 211.170(b)(3) - (3) For an OTC drug product that is exempt for bearing an expiration date under § 211.137, the re...

21 CFR 211.166(b) - (b) An adequate number of batches of each drug product shall be tested to determine an appropriat...

21 CFR 211.166(c)(1) - (1) There shall be a written assessment of stability based at least on testing or examination of ...

21 CFR 211.166(c)(2) - (2) Evaluation of stability shall be based on the same container-closure system in which the drug...

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)(1) - (1) Sample size and test intervals based on statistical criteria for each attribute examined to a...

21 CFR 211.166(a)(2) - (2) Storage conditions for samples retained for testing;

21 CFR 211.166(a)(3) - (3) Reliable, meaningful, and specific test methods;

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...

21 CFR 211.166(a)(5) - (5) Testing of drug products for reconstitution at the time of dispensing (as directed in the lab...

21 CFR 211.180(b) - (b) Records shall be maintained for all components, drug product containers, closures, and labeli...

21 CFR 211.180(f) - (f) Procedures shall be established to assure that the responsible officials of the firm, if they...

21 CFR 211.180(d) - (d) Records required under this part may be retained either as original records or as true copies...

21 CFR 211.180(c) - (c) All records required under this part, or copies of such records, shall be readily available f...

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)(1) - (1) A review of a representative number of batches, whether approved or rejected, and, where appl...

21 CFR 211.180(e)(2) - (2) A review of complaints, recalls, returned or salvaged drug products, and investigations condu...

21 CFR 211.196 - Distribution records.

21 CFR 211.194(d) - (d) Complete records shall be maintained of the periodic calibration of laboratory instruments, a...

21 CFR 211.194(e) - (e) Complete records shall be maintained of all stability testing performed in accordance with § ...

21 CFR 211.194(c) - (c) Complete records shall be maintained of any testing and standardization of laboratory referen...

21 CFR 211.194(b) - (b) Complete records shall be maintained of any modification of an established method employed in...

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)(1) - (1) A description of the sample received for testing with identification of source (that is, loca...

21 CFR 211.194(a)(2) - (2) A statement of each method used in the testing of the sample. The statement shall indicate th...

21 CFR 211.194(a)(3) - (3) A statement of the weight or measure of sample used for each test, where appropriate.

21 CFR 211.194(a)(4) - (4) A complete record of all data secured in the course of each test, including all graphs, chart...

21 CFR 211.194(a)(5) - (5) A record of all calculations performed in connection with the test, including units of measur...

21 CFR 211.194(a)(6) - (6) A statement of the results of tests and how the results compare with established standards of...

21 CFR 211.194(a)(7) - (7) The initials or signature of the person who performs each test and the date(s) the tests were...

21 CFR 211.194(a)(8) - (8) The initials or signature of a second person showing that the original records have been revi...

21 CFR 211.188(a) - (a) An accurate reproduction of the appropriate master production or control record, checked for ...

21 CFR 211.188 - Batch production and control records.

21 CFR 211.188(b) - (b) Documentation that each significant step in the manufacture, processing, packing, or holding ...

21 CFR 211.188(b)(10) - (10) Any sampling performed;

21 CFR 211.188(b)(11) - (11) Identification of the persons performing and directly supervising or checking each significa...

21 CFR 211.188(b)(12) - (12) Any investigation made according to § 211.192.

21 CFR 211.188(b)(13) - (13) Results of examinations made in accordance with § 211.134.

21 CFR 211.188(b)(2) - (2) Identity of individual major equipment and lines used;

21 CFR 211.188(b)(3) - (3) Specific identification of each batch of component or in-process material used;

21 CFR 211.188(b)(4) - (4) Weights and measures of components used in the course of processing;

21 CFR 211.188(b)(5) - (5) In-process and laboratory control results;

21 CFR 211.188(b)(6) - (6) Inspection of the packaging and labeling area before and after use;

21 CFR 211.188(b)(7) - (7) A statement of the actual yield and a statement of the percentage of theoretical yield at app...

21 CFR 211.188(b)(8) - (8) Complete labeling control records, including specimens or copies of all labeling used;

21 CFR 211.188(b)(9) - (9) Description of drug product containers and closures;

21 CFR 211.198(a) - (a) Written procedures describing the handling of all written and oral complaints regarding a dru...

21 CFR 211.198(b) - (b) A written record of each complaint shall be maintained in a file designated for drug product ...

21 CFR 211.198(b)(1) - (1) The written record shall include the following information, where known: the name and strengt...

21 CFR 211.198(b)(2) - (2) Where an investigation under § 211.192 is conducted, the written record shall include the fin...

21 CFR 211.198(b)(3) - (3) Where an investigation under § 211.192 is not conducted, the written record shall include the...

21 CFR 211.182 - Equipment cleaning and use log.

21 CFR 211.192 - Production record review.

21 CFR 211.184(a) - (a) The identity and quantity of each shipment of each lot of components, drug product containers...

21 CFR 211.184(b) - (b) The results of any test or examination performed (including those performed as required by § ...

21 CFR 211.184(d) - (d) Documentation of the examination and review of labels and labeling for conformity with establ...

21 CFR 211.184(c) - (c) An individual inventory record of each component, drug product container, and closure and, fo...

21 CFR 211.184(e) - (e) The disposition of rejected components, drug product containers, closure, and labeling.

21 CFR 211.186(a) - (a) To assure uniformity from batch to batch, master production and control records for each drug...

21 CFR 211.186(b)(1) - (1) The name and strength of the product and a description of the dosage form;

21 CFR 211.186(b)(2) - (2) The name and weight or measure of each active ingredient per dosage unit or per unit of weigh...

21 CFR 211.186(b)(3) - (3) A complete list of components designated by names or codes sufficiently specific to indicate ...

21 CFR 211.186(b)(4) - (4) An accurate statement of the weight or measure of each component, using the same weight syste...

21 CFR 211.186(b)(5) - (5) A statement concerning any calculated excess of component;

21 CFR 211.186(b)(6) - (6) A statement of theoretical weight or measure at appropriate phases of processing;

21 CFR 211.186(b)(7) - (7) A statement of theoretical yield, including the maximum and minimum percentages of theoretica...

21 CFR 211.186(b)(8) - (8) A description of the drug product containers, closures, and packaging materials, including a ...

21 CFR 211.186(b)(9) - (9) Complete manufacturing and control instructions, sampling and testing procedures, specificati...

21 CFR 211.208 - Drug product salvaging.

21 CFR 211.204 - Returned drug products.

21 CFR 212.10 - What personnel and resources must I have?

21 CFR 212.100(a) - (a) Written complaint procedures. You must develop and follow written procedures for the receipt...

21 CFR 212.20(b) - (b) Materials. You must examine and approve or reject components, containers, closures, in-proce...

21 CFR 212.20(e) - (e) Quality assurance. You must establish and follow written quality assurance procedures.

21 CFR 212.20(a) - (a) Production operations. You must oversee production operations to ensure that each PET drug m...

21 CFR 212.20(c) - (c) Specifications and processes. You must approve or reject, before implementation, any initial...

21 CFR 212.20(d) - (d) Production records. You must review production records to determine whether errors have occu...

21 CFR 212.30(a) - (a) Facilities. You must provide adequate facilities to ensure the orderly handling of materials...

21 CFR 212.30(b) - (b) Equipment procedures. You must implement procedures to ensure that all equipment that could ...

21 CFR 212.30(c) - (c) Equipment construction and maintenance. Equipment must be constructed and maintained so that...

21 CFR 212.40(b) - (b) Written specifications. You must establish appropriate written specifications for the identi...

21 CFR 212.40(d) - (d) Handling and storage. You must handle and store components, containers, and closures in a ma...

21 CFR 212.40(a) - (a) Written procedures. You must establish, maintain, and follow written procedures describing t...

21 CFR 212.40(c) - (c) Examination and testing

21 CFR 212.40(c)(2) - (2) You must examine a representative sample of each lot of containers and closures for conformit...

21 CFR 212.40(c)(1)(ii) - (ii) If you do not conduct finished-product testing of a PET drug product that ensures that the c...

21 CFR 212.50(a) - (a) Written control procedures. You must have written production and process control procedures ...

21 CFR 212.50(d) - (d) Area and equipment checks. The production area and all equipment in the production area must...

21 CFR 212.50 - What production and process controls must I have?

21 CFR 212.50(b) - (b) Master production and control records

21 CFR 212.50(b)(3) - (3) A complete list of components designated by names and codes sufficiently specific to indicate...

21 CFR 212.50(b)(5) - (5) An accurate statement of the weight or measurement of each component, using the same weight s...

21 CFR 212.50(b)(6) - (6) A statement of action limits on radiochemical yield, i.e., the minimum percentage of yield be...

21 CFR 212.50(b)(7) - (7) Complete production and control instructions, sampling and testing procedures, specifications...

21 CFR 212.50(c)(11) - (11) Results of any investigations conducted.

21 CFR 212.60(c) - (c) Analytical methods. Laboratory analytical methods must be suitable for their intended use an...

21 CFR 212.60(d) - (d) Materials. The identity, purity, and quality of reagents, solutions, and supplies used in te...

21 CFR 212.60(b) - (b) Specifications and standards. Each laboratory must have sampling and testing procedures desi...

21 CFR 212.60(a) - (a) Testing procedures. Each laboratory used to conduct testing of components, in-process materi...

21 CFR 212.60(e) - (e) Equipment. All equipment used to perform the testing must be suitable for its intended purpo...

21 CFR 212.60(f) - (f) Equipment maintenance. Each laboratory must have and follow written procedures to ensure tha...

21 CFR 212.60(g) - (g) Test records

21 CFR 212.60(g)(3) - (3) A complete record of all data obtained in the course of each test, including the date and tim...

21 CFR 212.60(g)(4) - (4) A statement of the results of tests and how the results compare with established acceptance c...

21 CFR 212.60(g)(5) - (5) The initials or signature of the person performing the test and the date on which the test wa...

21 CFR 212.61(a) - (a) Stability testing program. You must establish, follow, and maintain a written testing progra...

21 CFR 212.61(b) - (b) Storage conditions and expiration dates. The results of such stability testing must be docum...

21 CFR 212.70(e) - (e) Sterility testing. Sterility testing need not be completed before final release but must be ...

21 CFR 212.70(c) - (c) Conformance to specifications. Before final release, you must conduct an appropriate laborat...

21 CFR 212.70(b) - (b) Test procedures. Before you implement a new test procedure in a specification, you must esta...

21 CFR 212.70(f)(1)(iv) - (iv) You promptly correct the malfunction of analytical equipment, complete the omitted test usin...

21 CFR 212.70(d)(3) - (3) A designated qualified individual authorizes final release by dated signature.

21 CFR 212.71(b) - (b) Investigation. You must document the investigation of a PET drug product that does not meet ...

21 CFR 212.71(c) - (c) Correction of problems. You must take action to correct any identified problems to prevent r...

21 CFR 212.71(a) - (a) Rejection of nonconforming product. You must reject a batch of a PET drug product that does ...

21 CFR 212.110(b) - (b) Record quality. All records, including those not stored at the inspected establishment, must...

21 CFR 310.305(a) - (a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription dr...

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)...

21 CFR 310.305(c)(1)(i) - (i) Any person whose name appears on the label of a marketed prescription drug product as its man...

21 CFR 310.305(g)(3) - (3) Manufacturers, packers, and distributors must permit any authorized FDA employee, at all reas...

21 CFR 312.8(a)(3) - (3) A sponsor must obtain prior written authorization from FDA to charge for an investigational d...

21 CFR 312.7(b) - (b) Commercial distribution of an investigational new drug. A sponsor or investigator shall not ...

21 CFR 312.7(a) - (a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on...

21 CFR 312.6(a) - (a) The immediate package of an investigational new drug intended for human use shall bear a labe...

21 CFR 312.20(a) - (a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigati...

21 CFR 312.20(b) - (b) A sponsor shall not begin a clinical investigation subject to § 312.2(a) until the investigat...

21 CFR 312.20(c) - (c) A sponsor shall submit a separate IND for any clinical investigation involving an exception f...

21 CFR 312.64(d) - (d) Financial disclosure reports. The clinical investigator shall provide the sponsor with suffi...

21 CFR 312.64(a) - (a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who ...

21 CFR 312.64(b) - (b) Safety reports. An investigator must immediately report to the sponsor any serious adverse e...

21 CFR 312.58(a) - (a) FDA inspection. A sponsor shall upon request from any properly authorized officer or employe...

21 CFR 312.68 - Inspection of investigator's records and reports.

21 CFR 312.61 - Control of the investigational drug.

21 CFR 312.56(b) - (b) A sponsor who discovers that an investigator is not complying with the signed agreement (Form...

21 CFR 312.56(c) - (c) The sponsor shall review and evaluate the evidence relating to the safety and effectiveness o...

21 CFR 312.56(a) - (a) The sponsor shall monitor the progress of all clinical investigations being conducted under i...

21 CFR 312.60 - General responsibilities of investigators.

21 CFR 312.66 - Assurance of IRB review.

21 CFR 312.69 - Handling of controlled substances.

21 CFR 312.62(b) - (b) Case histories. An investigator is required to prepare and maintain adequate and accurate ca...

21 CFR 312.62(c) - (c) Record retention. An investigator shall retain records required to be maintained under this ...

21 CFR 312.62(a) - (a) Disposition of drug. An investigator is required to maintain adequate records of the disposi...

21 CFR 312.52(a) - (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this par...

21 CFR 312.55(a) - (a) Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give eac...

21 CFR 312.55(b) - (b) The sponsor shall, as the overall investigation proceeds, keep each participating investigato...

21 CFR 312.59 - Disposition of unused supply of investigational drug.

21 CFR 312.50 - General responsibilities of sponsors.

21 CFR 312.57(b) - (b) A sponsor shall maintain complete and accurate records showing any financial interest in § 54...

21 CFR 312.57(a) - (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition...

21 CFR 312.57(c) - (c) A sponsor shall retain the records and reports required by this part for 2 years after a mark...

21 CFR 312.57(d) - (d) A sponsor shall retain reserve samples of any test article and reference standard identified ...

21 CFR 312.53(a) - (a) Selecting investigators. A sponsor shall select only investigators qualified by training and...

21 CFR 312.53(b) - (b) Control of drug. A sponsor shall ship investigational new drugs only to investigators partic...

21 CFR 312.53(d) - (d) Selecting monitors. A sponsor shall select a monitor qualified by training and experience to...

21 CFR 312.53(c)(1) - (1) A signed investigator statement (Form FDA-1572) containing:

21 CFR 312.53(c)(2) - (2) Curriculum vitae. A curriculum vitae or other statement of qualifications of the investigato...

21 CFR 312.53(c)(4) - (4) Financial disclosure information. Sufficient accurate financial information to allow the spo...

21 CFR 314.80(b) - (b) Review of adverse drug experiences. Each applicant having an approved application under § 31...

21 CFR 314.80(d) - (d) Scientific literature. A 15-day Alert report based on information in the scientific literatu...

21 CFR 314.80(j) - (j) Recordkeeping. The applicant must maintain for a period of 10 years records of all adverse d...

21 CFR 314.80(c) - (c) Reporting requirements

21 CFR 314.80(c)(1)(i) - (i) Postmarketing 15-day “Alert reports”. The applicant must report each adverse drug experience...

21 CFR 314.80(c)(1)(ii) - (ii) Postmarketing 15-day “Alert reports”—followup. The applicant must promptly investigate all ...

21 CFR 314.80(c)(1)(iii) - (iii) Submission of reports. The requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this sec...

21 CFR 314.80(c)(1)(iv) - Our records indicate this regulation is no longer in the CFR. See ecfr.gov for more information

21 CFR 314.80(c)(2) - (2) Periodic adverse drug experience reports

21 CFR 314.80(c)(2)(ii)(A) - (A) Descriptive information.

21 CFR 314.80(c)(2)(ii)(B) - (B) ICSRs for serious, expected, and nonserious adverse drug experiences. An ICSR for each adver...

21 CFR 314.80(g)(1) - (1) Safety report submissions, including ICSRs, ICSR attachments, and the descriptive information...

21 CFR 314.80(e) - (e) Postmarketing studies

21 CFR 314.80(e)(2) - Our records indicate this regulation is no longer in the CFR. See ecfr.gov for more information

21 CFR 314.80(f)(1) - (1) Patient information.

21 CFR 314.80(f)(2) - (2) Adverse drug experience.

21 CFR 314.80(f)(4) - (4) Initial reporter information.

21 CFR 314.81(b)(1)(i) - (i) Information concerning any incident that causes the drug product or its labeling to be mistak...

21 CFR 314.81(b)(1)(ii) - (ii) Information concerning any bacteriological contamination, or any significant chemical, physi...

21 CFR 314.81(b)(2) - (2) Annual report

21 CFR 314.81(b)(2)(i) - (i) Summary. A brief summary of significant new information from the previous year that might af...

21 CFR 314.81(b)(2)(iii) - (iii) Labeling.

21 CFR 314.81(b)(2)(viii) - (viii) Status of other postmarketing studies. A status report of any postmarketing study not inc...

21 CFR 314.81(b)(2)(iv)(a) - (a) Reports of experiences, investigations, studies, or tests involving chemical or physical prop...

21 CFR 314.81(b)(2)(iv)(b) - (b) A full description of the manufacturing and controls changes not requiring a supplemental app...

21 CFR 314.81(b)(2)(vi)(b) - (b) Summaries of completed unpublished clinical trials, or prepublication manuscripts if availabl...

21 CFR 314.81(b)(2)(vii) - (vii) Status reports of postmarketing study commitments

21 CFR 314.81(b)(2)(vii)(a) - (a) Content of status report. The following information must be provided for each postmarketing ...

21 CFR 329.100(c)(1) - (1) Each report required to be submitted to FDA under section 760 of the FD&C Act, accompanied by...

21 CFR 361.1(c)(2) - (2) Function. Each Radioactive Drug Research Committee shall select a chairman, who shall sign a...

21 CFR 361.1(c)(3) - (3) Reports. Each Radioactive Drug Research Committee shall submit an annual report on or before...

21 CFR 361.1(c)(1)(ii) - (ii) a person qualified by training and experience to formulate radioactive drugs, and

21 CFR 361.1(f)(1) - (1) The statement “Rx only”;

21 CFR 361.1(f)(11) - (11) If the drug is intended for parenteral use, a statement as to whether the contents are steri...

21 CFR 361.1(f)(12) - (12) If the drug is for other than oral use, the names of all inactive ingredients, except that:

21 CFR 361.1(f)(2) - (2) The statement “To be administered in compliance with the requirements of Federal regulations ...

21 CFR 361.1(f)(4) - (4) The established name and quantity of each active ingredient;

21 CFR 361.1(f)(5) - (5) The name and half-life of the radionuclide, total quantity of radioactivity in the drug produ...

21 CFR 361.1(f)(9) - (9) The name and address of the manufacturer, packer, or distributor;

21 CFR 361.1(d)(6) - (6) Quality of radioactive drug. The radioactive drug used in the research study shall meet appr...

21 CFR 361.1(d)(7) - (7) Research protocol. No matter how small the amount of radioactivity, no study involving admin...

21 CFR 361.1(d)(9) - (9) Approval by an institutional review board. The investigator shall obtain the review and appr...

21 CFR 361.1(b)(3)(i) - (i) Under no circumstances may the radiation dose to an adult research subject from a single stud...