Source: https://www.federalregister.gov/documents/2002/02/07/02-3023/agency-information-collection-activities-proposed-collection-comment-request-cgmp-regulations-for
Timestamp: 2018-02-23 16:54:29
Document Index: 77590245

Matched Legal Cases: ['arts 210', 'art 211', 'art 211', '§\u2009211', 'art 211', '§\u2009211', '§\u2009211', '§\u2009211', '§\u2009211', 'art 211']

Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; CGMP Regulations for Finished Pharmaceuticals
Agency Information Collection Activities; Proposed Collection; Comment Request; CGMP Regulations for Finished Pharmaceuticals
Submit written or electronic comments on the collection of information by April 8, 2002.
67 FR 5825
5825-5828 (4 pages)
CGMP Regulations for Finished Pharmaceuticals—21 CFR Parts 210 and 211 (OMB Control No. 0910-0139)—Extension
https://www.federalregister.gov/d/02-3023 https://www.federalregister.gov/d/02-3023
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with the CGMP to ensure that such drug meets the requirements of the act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
The general requirements for recordkeeping under part 211 (21 CFR part 211) are set forth in § 211.180. Any production, control, or distribution record associated with a batch and required to be maintained in compliance with part 211 must be retained for at least 1 year after the expiration date of the batch and, for certain over-the-counter (OTC) drugs, 3 years after distribution of the batch (§ 211.180(a)). Records for all components, drug product containers, closures, and labeling are required to be maintained for at least 1 year after the expiration date and 3 years for certain OTC products (§ 211.180(b)).
In order to facilitate improvements and corrective actions, records must be maintained so that data can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures (§ 211.180(e)). Written procedures for these evaluations are to be established and include provisions for a review of a representative number of batches and, where applicable, records associated Start Printed Page 5826with the batch, and provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted under § 211.192 for each drug product.
Section 211.160(a)—The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanism, must be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. These requirements must be followed and documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms must be recorded and justified.
Section 211.182—This section specificies requirements for equipment cleaning records and the use log.
Section 211.184—This section specifies requirements for component, drug product container, closure, and labeling records.
Section 211.186—This section specifies master production and control records requirements.
Section 211.188—This section specifies batch production and control records requirements.
Section 211.192—This section specifies the information that must be maintained on the investigation of discrepancies found in the review of all drug product production and control records by the quality control staff.
Section 211.194—This section explains and describes laboratory records that must be retained.
Section 211.196—This section specifies the information that must be included in records on the distribution of the drug.
Start Printed Page 5827
Section 211.198—This section specifies and describes the handling of all complaint files received by the applicant.
Section 211.204—This section specifies that records be maintained of returned and salvaged drug products and describes the procedures involved.
1. Section 211.22(d)—Responsibilities and procedures of the quality control unit;
2. Section 211.56(b)—Sanitation procedures;
3. Section 211.56(c)—Use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents;
4. Section 211.67(b)—Cleaning and maintenance of equipment;
5. Section 211.68(a)—Proper performance of automatic, mechanical, and electronic equipment;
6. Section 211.80(a)—Receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers or closures;
7. Section 211.94(d)—Standards or specifications, methods of testing, and methods of cleaning, sterilizing, and processing to remove pyrogenic properties for drug product containers and closures;
8. Section 211.100(a)—Production and process control;
9. Section 211.110(a)—Sampling and testing of in-process materials and drug products;
10. Section 211.113(a)—Prevention of objectionable microorganisms in drug products not required to be sterile;
11. Section 211.113(b)—Prevention of microbiological contamination of drug products purporting to be sterile, including validation of any sterilization process;
12. Section 211.115(a)—System for reprocessing batches that do not conform to standards or specifications, to insure that reprocessed batches conform with all established standards, specifications, and characteristics;
13. Section 211.122(a)—Receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials;
14. Section 211.125(f)—Control procedures for the issuance of labeling;
15. Section 211.130—Packaging and label operations, prevention of mixup and cross contamination, identification and handling of filed drug product containers that are set aside and held in unlabeled condition, identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch;
16. Section 211.142—Warehousing;
17. Section 211.150—Distribution of drug products;
18. Section 211.160—Laboratory controls;
19. Section 211.165(c)—Testing and release for distribution;
20. Section 211.166(a)—Stability testing;
21. Section 211.167—Special testing requirements;
22. Section 211.180(f)—Notification of responsible officials of investigations, recalls, reports of inspectional observations, and any regulatory actions relating to good manufacturing practice;
23. Section 211.198(a)—Written and oral complaint procedures, including quality control unit review of any complaint involving specifications failures, and serious and unexpected adverse drug experiences;
24. Section 211.204—Holding, testing, and reprocessing of returned drug products; and
25. Section 211.208—Drug product salvaging.
The burden estimates for the recordkeeping requirements in table 1 of this document are based on: (1) FDA's institutional experience regarding creation and review of such procedures and similar recordkeeping requirements and (2) data provided to FDA to prepare an economic analysis of the potential economic impact of the May 3, 1996, proposed rule entitled “Current Good Manufacturing Practice: Proposed Amendment of Certain Requirements for Finished Pharmaceuticals” (61 FR 20104). Annual SOP maintenance is estimated to involve 1 hour annually per SOP, totaling 25 hours annually per recordkeeper.
The May 3, 1996, proposed rule revising part 211 CGMP requirements would require additional SOPs. Cost estimates for those additional SOPs were included in the proposed rule, but are not included here. Any comments on those estimates will be evaluated in any final rule based on that proposal
FDA estimates the total burden of this collection of information as follows:
[FR Doc. 02-3023 Filed 2-6-02; 8:45 am]