Good manufacturing practice standard

A variety of product safety, work safety, environmental safety aspects and other legal aspects must be taken into consideration when a process is designed. Good Manufacturing Practice standards for facilities, equipment, and working procedures must be met. GMP approval is subject to inspection and requires constant attention and updating. Extensive documentation must be provided to comply with these requirements. 

Good manufacturing practices Standards set by industry groups or individual manufacturer (not yet established by FDA) Set by FDA... 

In the case of imported medicinal products, the importer shall ensure that the products have been manufactured by manufacturers duly authorized and conforming to good manufacturing practice standards, at least equivalent to those laid down by the European Community. A copy of the manufacturing authorization shall be available. 

The qualified person shall ensure that each batch of a registered proprietary medicinal product imported from non-EC Member States has been manufactured by manufacturers duly authorized in conformity with good manufacturing practice standards at least equivalent to those laid down by this Executive Order and with the conditions of the marketing authorization. 

Calibration. Cahbration of lab instmments is important to the accuracy of test results. CaUbration, the use of an accepted standard to adjust an instmment or measurement standard so as to improve the accuracy of the instmment or measurement, is an essential requirement of both the U.S. Food and Dmg Administration (FDA) Good Manufacturing Practice (GMP) (24) and the ISO 9000 standards (25). 

Besides internal quaUty audits, there are audits conducted by external authorities for conformance to estabUshed quaUty systems. The two chief standards affecting the chemical industry are the U.S. Food and Dmg Administration Current Good Manufacturing Practice (GMP) regulation and the International Organization for Standardization ISO 9000 series. A quaUty system performance-related standard is the Malcolm Baldrige National QuaUty Award... 

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. 

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). 

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. 

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). 

Parts 100 to 169. Food standards, good manufacturing practice for foods, low-acid canned foods, acidified foods, and food labeling. 

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

The manufacture of all investigational medicinal products (including placebo) that are intended for a clinical trial must be authorised and conducted according to Good Manufacturing Practice (GMP). This should be supervised and certified by a Qualified Person . An import authorisation is required for any product from outside the EU, which should also be manufactured to GMP standards. (See Ghapters 11 and 12 for information on GMP, manufacturing authorisations and Qualified Persons.)... 

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

Good manufacturing practices (GMPs) ensure that products meet specific quality standards, are not adulterated or misbranded, and contain the correct ingredients and doses stated on the label. GMPs specifically for dietary supplements are being proposed from the FDA. Cases of adulteration have been reported to the FDA, and examples include a plantain product adulterated with digitalis and hibiscus tea adulterated with warfarin [29]. 

One of the alternative approaches under the 510(k) paradigm is Special 510(k) Device Modifications. This approach utilizes certain aspects of the Quality System Regulations (Quality System Requirements for Good Manufacturing Practices). The other alternative is the Abbreviated 510(k). This approach utilizes special controls in which standards or voluntary guidelines can facilitate 510(k) review and expedite evaluation. 

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