Good pharmaceutical manufacturing practice

Lactic acid is generally recognized as safe (GRAS) for multipurpose food use. Lactate salts such as calcium and sodium lactates and esters such as ethyl lactate used in pharmaceutical preparations are also considered safe and nontoxic (7). The U.S. Food and Dmg Administration fists lactic acid (all isomers) as GRAS and sets no limitations on its use in food other than current good manufacturing practice (46). 

Two similar dosage forms, eg, tablets, that contain the same amount of the same dmg entity and meet USP/NF and current good manufacturing practices (FDA) are referred to as pharmaceutical equivalents (PE). When, upon adiriinistration, such tablets achieve similar profiles of AUC, and... 

Good Manufacturing Practice. The GMPs were issued by the U.S. FDA in 1978 to provide minimum quahty standards in the production of pharmaceuticals (qv) for the finished dosage form as well as their ingredients. The standard has been updated periodically. 

Current Good Manufacturing Practice for Finished Pharmaceuticals," Code of Federal Regulations, Tide 21, Part 211.25, U.S. FDA, Washington, D.C., 1988. 

Food and pharmaceutical grades of calcium carbonate are covered by the Food Chemicals Codex (7) and the United States Pharmacopeia (8) and subject to U.S. Food and Dmg Administration Good Manufacturing Practices (9). Both purity requirements and test methods are available (7,8). Calcium carbonate is listed in the U.S. Code of Federal Regulation as a food additive, and is authorized for use in both paper and plastic food contact appHcations. 

Current Good Manufacturing Practice for Finished Pharmaceuticals, Sampling and Testing of In-Process Materials and Drug Products, (1998), CFR, Title 21, Part 211, Volume 4, Section 211.110. 

Current Good Manufacturing Practices for Finished Pharmaceuticals, U.S. Food and Drug Administration, 21 CFR 210 and 211... 

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients... 

Part 211, current Good Manufacturing Practice for Finished Pharmaceuticals. 

Annex 18 Good manufacturing practice for active pharmaceutical ingredients (The ICH Guide) Annex 19 Reference and Retention Samples... 

Pharmaceutical products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice and Good Laboratory Practice. 

In 2002, the FDA announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century . The purposes of this... 

Since the U.S. vs. Barr decision in 1993 (relevant to pharmaceuticals and related fields, rules applied by the Federal Food Drug Administration, FDA), outlier tests may no longer be applied to physicochemical tests, under the assumption that such test methods, having been optimized and validated for the particular set of circumstances, rarely produce outliers. These tests may not be applied to CU results at all. Good manufacturing practices mandate that operators work according to pre-set procedures and write down any observed irregularities as they... 

Quality Control Records. Accurate quality control records are of utmost importance and may be required by law, as in the pharmaceutical industry. A few years ago, mandatory Good Manufacturing Practices were proposed for the cosmetic industry. Although the proposal was later dropped, many manufacturers go by the rules worked out at that time for laboratory testing and record keeping. The food industry also requires extensive testing and record keeping. 

Good manufacturing practices for pharmaceutical products. In WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823, Annex 1). 

Medicinal products and bulk pharmaceutical chemicals are produced mainly in batch processes. Controlling these products and chemicals at the end of their manufacturing processes is not in line with the general principle of quality assurance, which is that quality should be built into the product. It is then necessary to ensure that appropriate good manufacturing practices are adhered to throughout the manufacture of both bulk pharmaceutical chemicals (active ingredients as well as excipients) and medicinal products. 

Good Manufacturing Practice and certification of starting materials for the industrial manufacture of medicinal products. Concept paper on a Community regulatory framework , 1995 European Commission, Directorate General IE, Industry Consumer Goods Industries III/E/3 Pharmaceuticals, July. 

Good Manufacturing Practice for Pharmaceutical Products , 1992, WHO Technical Reports Series, No 823. 

Chemical and pharmaceutical manufacturers must establish their own internal reference materials, when no pharmacopoeial monograph exists, to satisfy the requirements of Good Manufacturing Practice (European Commission 1997). 

PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS... 

Current Good Manufacturing Practices [135] establish the requirements for maintaining a stability program and require that most pharmaceutical dosage forms have an established expiration date supported by test data [134]. There are few allowable exceptions. 

Code of Federal Regulations, Title 21, Food and Drugs, Part 211, Current good manufacturing practice for finished pharmaceuticals, Subpart G, 211.137 Expiration Dating. 

The current Good Manufacturing Practice (cGMP) regulations are guidelines that FDA requires a pharmaceutical manufacturer to meet. Compliance with the cGMPs is a prerequisite for the approval of NDAs, INDs, and antibiotic forms. General areas in which... 

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