By Food and Drug Administration

Compact Regs components 210 and 211. content material: publication conceal; identify; Copyright; half 210-CURRENT stable production perform IN production, PROCESSING, PACKING, OR protecting of substances; normal; half 211--CURRENT stable production perform FOR comprehensive prescription drugs; key-phrase INDEX TO 21 CFR elements 210 AND 211. summary: Compact Regs elements 210 and 211

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Extra info for Compact Regs Parts 210 and 211 : Cfr 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical Gmps (10 Pack)

Sample text

D) Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in the batch production record. (e) Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records.

5, 1982; 50 FR 8996, Mar. 6, 1985; 55 FR 11577, Mar. 29, 1990; 66 FR 56035, Nov. 180 General requirements. 137, 3 years after distribution of the batch. 137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling. (c) All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred.

43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41354, Aug. 130 Packaging and labeling operations. There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate the following features: (a) Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products. (b) Identification and handling of filled drug product containers that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots.

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