Chemistry

Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 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 entire and feature now not been altered in any demeanour from the unique assets. they're the proper inexpensive instruments for: staff as a part of documented GMP education courses, for suppliers/vendors so they could provide elements, labels, and components with an figuring out of FDA specifications, and for every medical investigator, nurse, and technician to assist guarantee compliance to medical trial protocols. A key-phrase index are available on the finish of every e-book.

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Additional resources for Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical GMPs

Example text

Such procedures shall include validation of any sterilization process. 115 Reprocessing. (a) Written procedures shall be established and followed prescribing a system for reprocessing 39 batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics. (b) Reprocessing shall not be performed without the review and approval of the quality control unit. 122 Materials examination and usage criteria.

Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified. 52 (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products.

D) Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be stored separately with suitable identification. Access to the storage area shall be limited to authorized personnel. (e) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed. (f) Use of gang-printed labeling for different drug products, or different strengths or net contents of the same drug product, is prohibited unless the labeling from gang-printed sheets is adequately differentiated by size, shape, or color.

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