Good Manufacturing Practices GMPs

Blood transfusion is highly regulated worldwide by government institutions, such as the USFDA, and through associations of blood banks, such as the American Association of Blood Banks (AABB). Strict regulations on good manufacturing practices (GMP) have been estabhshed to ensure maximum safety of the transfused products. 

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). 

Quahty assurance must remain independent of manufacturing so that problems can be reported freely to upper management without fear of retribution. QA should have oversight responsibihty for QC. A reporting stmcture helps to ensure the independence of both quahty units and conforms to both Good Manufacturing Practice (GMP) and ISO 9000 requirements. 

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... 

The use or presence of poisonous or deleterious substances in cosmetics and dmgs is prohibited. The presence of such materials makes the product "adulterated" or "misbranded" and in violation of good manufacturing practices (GMP), which ate appHcable to dmgs and, with minor changes, to cosmetics (6). 

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). 

E-number and generic name, eg, lysozyme or glucose oxidase. AMEEP has defined Good Manufacturing Practice (GMP) for microbial food enzymes. 

Quality system regulation The past good manufacturing practice (GMP) and process validation (PV) was renamed to quality system regulation (QSR). It is important for the medical device industry (that uses an extensive amount of plastics) and also in other product industries where they want to follow strict processing procedures. It sets up an important procedure for many plastic fabricators to consider that targets to ensure meeting zero defects. 

There are a number of other regulations/directives that you will need to consult, as appropriate. These address topics such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), the conduct of clinical trials, variations to authorised drugs, and the use of genetically modified organisms. A list of the most relevant directives is shown in Table 1.5. 

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). 

Investigational products should be manufactured, handled, and stored in accordance with applicable 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.)... 

All stages of antibiotic manufacture from fermentation through to finished product are governed by the code of good manufacturing practice (GMP), of whieh quality eontrol is one aspect. GMP requires that there should be a eomprehensive system, so designed, documented, implemented and controlled, and so furnished with personnel, equipment and other resourees as to provide assuranee that products will consistently be of a quality appropriate to their intended use. ... 

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. 

Good manufacturing practice (GMP) comprises that part of quality assurance which is aimed at ensuring that a product is consistently manufactured to a quality appropriate to its intended use. GMP requires that (i) the manufacturing process is fully defined before it is commenced and (ii) the necessary facilities are provided. In practice, this means that personnel must be adequately trained, suitable premises and equipment employed, correct materials used, approved procedures adopted, suitable storage and transport facilities available and appropriate records made. 

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]. 

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