WebJan 17, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 58.195 Retention of records. (a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter. (b) Except as provided in paragraph (c) of this ... WebTitle 21 Part 58 of the Electronic Code of Federal Regulations. Title 21, ... Toggle navigation eCFR. Home; Title 21 PART 58. CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part …
21CFR Part 58 The Good Laboratory Practices GLP Regulation
WebThe preamble to the . DRAFT 4 final rule issuing Part 58 generally discusses when Part 58 applies and also lists certain ... The GLP regulations are found in 21 CFR Part 58: ... WebAug 24, 2016 · Part 58 (21 CFR part 58) presently includes many aspects of a quality system approach. However, ... (Ref. 12). Also, in the preamble to the 1987 final rule amending part … halton region waste
eCFR :: 21 CFR 58.81 -- Standard operating procedures.
WebEnsure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented; Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap WebThe new narrow scope of the guidance states that Part 11 applies when: The record is required by a predicate rule, e.g., electronic batch records for 21 CFR Part 211 and electronic training records in 21 CFR Part 58. The electronic records are used to demonstrate compliance with a predicate rule, e.g., electronic training records for Web58.35 Quality assurance unit. Subpart C—Facilities 58.41 General. 58.43 Animal care facilities. 58.45 Animal supply facilities. 58.47 Facilities for handling test and con-trol articles. 58.49 Laboratory operation areas. 58.51 Specimen and data storage facilities. Subpart D—Equipment 58.61 Equipment design. 58.63 Maintenance and calibration ... halton region waste schedule