Good Manufacturing Practice United States

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. 

Decaffeination Regulations. Eor decaffeinated roasted coffee, EEC standards indicate the maximum content of caffeine as 0.1% db for decaffeinated instant coffee it is 0.3% db. In the United States, decaffeination usually signifies that 97% of the caffeine has been removed. Permissible solvents for decaffeination processes are defined by national legislation, eg, EDA or EEC directive. The maximum residual solvent content after decaffeination, roasting, or instant coffee processing is to be kept within good manufacturing practice, ie, very low ppm levels or below at point of sale (46). 

Production Facilities. The manufacture of acceptable cosmetic products requires not only safe ingredients but also faciUties that maintain high standards of quaUty and cleanliness. Most countries have estabUshed regulations intended to assure that no substandard product or batch is distributed to consumers. Good Manufacturing Practices (GMP) represent workable standards that cover every aspect of dmg manufacture, from building constmction to distribution of finished products. GMPs in the United States that have been estabUshed for dmg manufacture are commonly used in cosmetic production (6,25). 

If the product is to be marketed in the United States, the plant must meet the FDA s good manufacturing practices (GMP) requirements (which now apply in most of the developed countries). If other products are being manufactured in a given plant for sale in the United States, it is not a certainty that the FDA will inspect the plant for the production of each new compound fhaf is to be produced therein. It is virtually certain that the plant will be inspected, however, if the company has not been previously cleared by the FDA for manufacturing or sale in the United States. Inspection is also likely if the new process represents a significant deviation from the processes that have been carried out in the plant in the past. Requests to the FDA for plant inspection should be made as early in the NDA cycle as the law permits as scheduling the actual date for inspection can be a problem. 

In 1994, the United States Congress, influenced by growing "consumerism" as well as strong manufacturer lobbying efforts, passed the DSHEA. DSHEA required the establishment of Good Manufacturing Practice (GMP) standards for the supplement industry however, it was not until 2007 that the FDA issued a final rule on the proposed GMP standards. This... 

Parts 210 and 211 of CFR Title 21 are the laws defining good manufacturing practices for finished pharmaceutical products. All manufacturers must follow these regulations in order to market their products in the United States. When a firm files an application to market a product in the United States through a New Drug Application (NDA), abbreviated NDA, (ANDA), Biological License Application (BLA),... 

An interesting issue has surfaced at the time of writing (October 2004) when the supply of influenza vaccine in both the United States and United Kingdom became severely limited owing to a failure in good manufacturing practices within... 

This chapter will deal with the objective of manufacturing excipient ingredients to appropriate good manufacturing practices (GMP) requirements, as stipulated by the United States Pharmacopeia (USP) (1) and the International Pharmaceutical Excipients Council excipient GMP guide (2). It is beyond the scope to address the many quality techniques for minimizing variation in excipient quality. However this chapter will address the issues concerning assurance that all excipient material within each batch meets compendial or manufacturer s specification. 

Good Manufacturing Practices for Bulk Pharmaceutical Excipients. United States Pharmacopeia 24, General Chapter <1078>, 2040-2049 (2000). 

EC-U.S. MRA on Pharmaceutical Good Manufacturing Practices. After a three-year implementation period, this agreement enables the FDA to rely on our counterparts in the EU to inspect facilities in their countries that manufacture drugs for the United States market. For more... 

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