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" For each drug product, masterformula records shall be prepared, endorsed, and dated by a competent and responsible individual and shall be independently checked, reconciled, endorsed, and dated by a second competent and responsible individual. The record... "
The Code of Federal Regulations of the United States of America - Page 77
1969
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Drug Safety, Part 4

United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 448 pages
...disposition, and use in drug manufacture or processing.* 9 133.7 Muter-formula and hatch-production records. (a) For each drug product, master-formula...individual actively performing or the individual actively supervising or checking each step in the operation. (3) A batch number that permits determination of...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1964 - 1784 pages
...batch-production records. (a) For each drug product, masternnula records shall be prepared, enirsed, and dated by a competent and responsible individual...individual actively performing or the individual actively supervising or checking each step in the operation. (3) A batch number that permits determination of...
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Drug Safety: Hearings Before a Subcommittee of the Committee on ..., Parts 1-2

United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 1600 pages
...their origin, receipt, examination, testing, disposition, and use in drug manufacture or processing.* g 133.7 Master-formula and batch-production records....batch, including dates, specific identification of each bati ti of components used, weights or measures of components and products in conr=e of processing,...
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Drug Safety: Hearings Before a Subcommittee of the Committee on Government ...

United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 844 pages
...shall be retained for at least 2 years after distribution has been completed. The batch-prodnction and control record shall include: (1) An accurate...individual actively performing or the individual actively supervising or checking each step in the operation. (3) A batch number that permite determination of...
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Competitive problems in the drug industry: hearings before Subcommittee on ...

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - Pharmaceutical industry - 1967 - 410 pages
...theoretical yield. (4) A description of the containers, closures, packaging, and finishing materials. <o) Manufacturing and control instructions, procedures,...individual actively performing or the individual actively supervising or checking each step in the operation. (3) A batch number that permits determination of...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1969 - 698 pages
...their origin, receipt, examination, testing, disposition, and use in drug manufacture or processing. [30 FR 932, Jan. 29. 1965] § 133.7 Master-formula...individual actively performing or the individual actively supervising or checking each step in the operation. (3) A batch number that permits determination of...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its ...

Cosmetics - 1979 - 840 pages
...after distribution has been completed. Tbe batch-production and control record shall Include: . i} An accurate reproduction of the appropriate master-formula...individual actively performing or the individual actively supervising or checking each step in the operation. (3) A batch number that permits determination of...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its ...

Cosmetics - 1979 - 1068 pages
...years after distribution has been completed. The batch-production and control record shall Inelude: (1) An accurate reproductIon of the appropriate master-formula...controlling of the batch, including dates, specific identifleatlon of each batch of components used, weights or measures of components and products In...
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The Code of Federal Regulations of the United States of America

Administrative law - 1968 - 636 pages
...their origin, receipt, examination, testing, disposition, and use in drug manufacture or processing. [30 FR 932, Jan. 29, 1965] § 133.7 Master-formula...individual actively performing or the individual actively supervising or checking each step in the operation. (3) A batch number that permits determination of...
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The Code of Federal Regulations of the United States of America

Administrative law - 1970 - 654 pages
...origin, receipt, examination, testing, disposition! and use in drug manufacture or processing. [30 FB 932, Jan. 29, 1965] § 133.7 Master-formula and batch-production...individual actively performing or the individual actively supervising or checking each step in the operation. (3) A batch number that permits determination of...
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