General Good Manufacturing Practices

GENERAL GOOD MANUFACTURING PRACTICES GUIDELINES FOR FOOD CHEMICALS4... 

The following general good manufacturing practice (GMP) requirements are applicable to computer systems. 

Static-Blok FDA-3 Anti-Static Solution is an aqueous solution Of one of a group of surface active materials regulated by the FDA under CFR 178.3400 for use in the manufacture of articles that contact food. There is no limitation in this regulation of the kind of food allowed to contact an article containing Static-Blok FDA-3, or on the kind of material (plastic, etc.) of which the article is made, or on the level of Static-Blok FDA-3 except for the general "good manufacturing practice" requirements to use no more than necessary and that "the quantity that may become a component of food shall not be intended to, nor in fact, to accomplish any physical or technical effect in the food Itself." Form Liquid Solubility in Isopropanol 100%... 

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). 

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

No coloi additive oi product containing one can be used in the aiea of the eye, in surgical sutures, or in injections, unless so stated. Also, no colorant can be used to color foods for which standards of identity have been promulgated under Section 401 of the Federal Food, Dmg, and Cosmetic Act, unless the use of added color is authorized by the standard. Colorants without restrictions can be used for coloring foods generally, in amounts consistent with good manufacturing practice. 

Chapter 22 deals with general factory and hospital hygiene and the principles of good manufacturing practice (GMP) whieh if adhered to go a long w towards compormding the success of the processes deseribed in Chapters 17 and 20. 

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. 

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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