Compact Regs CFR 21: Parts 210 and 211, Pharmaceutical and by Food and Drug Administration

By Food and Drug Administration

The Compact Regs sequence offers full-text, pocket-sized structure (3 3/4 inch x five 0.5 inch) verbatim reproductions of key US FDA rules. The texts are whole and feature no longer been altered in any demeanour from the unique resources. they're the right reasonably cheap instruments for: staff as a part of documented GMP education courses, for suppliers/vendors so they may supply elements, labels, and elements with an knowing of FDA standards, and for every scientific investigator, nurse, and technician to assist guarantee compliance to medical trial protocols. A key-phrase index are available on the finish of every publication.

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Additional info for Compact Regs CFR 21: Parts 210 and 211, Pharmaceutical and Bulk Chemical GMPs (10-pack)

Sample text

The reserve sample shall be stored in the same immediate containerclosure system in which the drug product is marketed or in one that has essentially the same characteristics. The reserve sample consists of at least twice the quantity necessary to perform all the required tests, except those for sterility and pyrogens. Except for those for drug products described in paragraph (b)(2) of this section, reserve samples from representative sample lots or batches selected by acceptable statistical procedures shall be examined visually at least once a year for evidence of deterioration unless visual examination would affect the integrity of the reserve sample.

Deviation from this requirement is permitted if such deviation is temporary and appropriate. (b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary. 160 General requirements. (a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.

The written program shall be followed and shall include: (1) Sample size and test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability; (2) Storage conditions for samples retained for testing; (3) Reliable, meaningful, and specific test methods; (4) Testing of the drug product in the same container-closure system as that in which the drug product is marketed; (5) Testing of drug products for reconstitution at the time of dispensing (as directed in the labeling) as well as after they are reconstituted.

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