| 1964 - 1242 pages
...Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test procedures to assure that components, drug...samples. Such records shall also provide for appropriate retesting of materials subject to deterioration. (b) The establishment of appropriate specifications,... | |
| 1974 - 402 pages
...adequate specifications and test procedures to assure that the drug components and the medicated premixes conform to appropriate standards of identity, strength,...master records containing appropriate specifications and a description of the test proChapter I — Food and Drug Administration cedures used to check them... | |
| 1993 - 192 pages
...the drug components and the Type A medicated article(s) conform to appropriate standards of fdentity, strength, quality, and purity. Laboratory controls...master records containing appropriate specifications and a description of the test procedures used to check them for each kind of drug component used in... | |
| 2003 - 210 pages
...assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity,...quality, and purity. Laboratory controls shall include: (1) Determination of conformance to appropriate written specifications for the acceptance of each lot... | |
| 1992 - 208 pages
...assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity,...quality, and purity. Laboratory controls shall include: ( 1 ) Determination of conf ormance to appropriate written specifications for the acceptance of each... | |
| 1997 - 200 pages
...assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appro-priate standards of identity,...quality, and purity. Laboratory con-trols shall include: (1) Determination of conformance to appropriate written specifications for the acceptance of each lot... | |
| United States. Congress. House. Committee on Government Operations - 1964 - 448 pages
...include the establishment of adequate specifications and test procedures to assure that conponents, drug preparations in the course of processing, and...samples. Such records shall also provide for appropriate retesting of materials subject to deterioration. (b) The establishment of appropriate specifications,... | |
| United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...preparations in the ourse of processing, and finished products conform to appropriate standards of aentity, strength, quality, and purity. Laboratory controls...establishment of master records containing appropriate speciflealons for each kind and quality of raw material used in drug production and a scription of... | |
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