Source: https://www.federalregister.gov/documents/2002/05/16/02-12263/agency-information-collection-activities-submission-for-omb-review-comment-request-cgmp-regulations
Timestamp: 2017-10-24 04:40:27
Document Index: 170885615

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

Federal Register :: Agency Information Collection Activities; Submission for OMB Review; Comment Request; CGMP Regulations for Finished Pharmaceuticals
A Notice by the Food and Drug Administration on 05/16/2002
Submit written comments on the collection of information by June 17, 2002.
67 FR 34939
34939-34942 (4 pages)
Docket No. 02N-0007
02-12263
CGMP Regulations for Finished Pharmaceuticals—21 CFR Parts 210 and 211 (OMB Control Number 0910-0139)—Extension
https://www.federalregister.gov/d/02-12263 https://www.federalregister.gov/d/02-12263
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 Start Printed Page 34940the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices (CGMPs) 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.
FDA has the authority under section 701(a) of the act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the act regarding CGMP procedures for manufacturing, processing, and holding drugs and drug products. The CGMP regulations help ensure that drug products meet the statutory requirements for safety and have their purported or represented identity, strength, quality, and purity characteristics. The information collection requirements in the CGMP regulations provide FDA with the necessary information to perform its duty to protect public health and safety. CGMP requirements establish accountability in the manufacturing and processing of drug products, provide for meaningful FDA inspections, and enable manufacturers to improve the quality of drug products over time. The CGMP recordkeeping requirements also serve preventive and remedial purposes and provide crucial information if it is necessary to recall a drug product.
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 with 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 211.68(b)—All appropriate controls must be exercised over all computers or related systems and control data systems to assure that changes in master production and controls records or other records are instituted only by authorized persons.
Section 211.137—Requirements regarding product expiration dating and compliance with 21 CFR 201.17.
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 Start Printed Page 34941laboratory 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 211.166(c)—Specifies homeopathic drug product requirements.
Section 211.180(e)—Written records required by this part 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. Written procedures must be established and followed for such evaluations and must include provisions for a representative number of batches, whether approved or unapproved or rejected, and a review of complaints, recalls, returned or salvaged drug products, and investigations conducted under § 211.192 for each drug product.
Section 211.180(f)—Procedures must be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations, conducted under § 211.198, § 211.204, or § 211.208, any recalls, reports of inspectional observations issued, or any regulatory actions relating to good manufacturing practices brought by FDA.
Section 211.182—Specifically explains equipment cleaning and the use log.
Section 211.184—Specifies component, drug product container, closure, and labeling records.
Section 211.186—Specifies master production and control records.
Section 211.188—Specifies batch production and control records.
Section 211.194—Explanation and description of laboratory records that must be retained.
Section 211.204—Specifies that records be maintained of returned and salvaged drug product and describes the procedures involved.
Written procedures, referred to here as standard operating procedures (SOPs), are required for many part 211 records. The current SOP requirements were initially provided in a final rule published in the Federal Register of September 29, 1978 (43 FR 45014), and are now an integral and familiar part of the drug manufacturing process. The major information collection impact of SOPs results from their creation. Thereafter, SOPs need to be periodically updated. A combined estimate is provided in table 1 of this document for routine maintenance of SOPs. The 25 SOP provisions under part 211 in the combined maintenance estimate include:
(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, 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 mix-up 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 FDA's institutional experience regarding creation and review of such procedures and similar recordkeeping requirements, and 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.
In the Federal Register of February 7, 2002 (67 FR 5825), the agency requested comments on the proposed collection of information. There were no comments received.
21 CFR ­Section
SOP Maintenance (See previous list of 25 SOPs) 4,184 1 4,184 25 104,600
New startup SOPs 100 25 2,500 20 50,000
211.34 4,184 .25 1,046 .5 523
211.67(c) 4,184 50 209,200 .25 52,300
211.68 4,184 2 8,368 1 8,368
211.68(a) 4,184 10 41,840 .5 20,920
211.68(b) 4,184 5 20,920 .25 5,230
211.72 4,184 .25 1,046 1 1,046
211.80(d) 4,184 .25 1,046 .1 105
211.100(b) 4,184 3 12,552 2 25,104
211.105(b) 4,184 .25 1,046 .25 262
211.122(c) 4,184 50 209,200 .25 52,300
211.130(e) 4,184 50 209,200 .25 52,300
211.132(c) 1,698 20 33,960 .5 16,980
211.132(d) 1,698 .2 340 .5 170
211.137 4,184 5 20,920 .5 10,460
211.160(a) 4,184 2 8,368 1 8,368
211.165(e) 4,184 1 4,184 1 4,184
211.166(c) 4,184 2 8,368 .5 4,184
211.173 1.077 1 1,077 .25 269
211.180(e) 4,184 .2 837 .25 209
211.180(f) 4,184 .2 837 1 837
211.182 4,184 2 8,368 .25 2,092
211.184 4,184 3 12,552 .5 6,276
211.186 4,184 10 41,840 2 83,680
211.188 4,184 25 104,600 2 209,200
211.192 4,184 2 8,368 1 8,368
211.194 4,184 25 104,600 .5 52,300
211.196 4,184 25 104,600 .25 26,150
211.198 4,184 5 20,920 1 20,920
211.204 4,184 10 41,840 .5 20,920
Total 848,625
[FR Doc. 02-12263 Filed 5-15-02; 8:45 am]