Pharmaceutical products manufacturing

G.J. farquharson. Building and facility design for clean and sterile pharmaceutical product manufacture. In J.H. Vincent, ed. Ventilation SS Proceedings of the Second International Symposium on Ventilation for Contaminant Control, pp. 231-236, Pergamon Pre.ss, Oxford, 1989,... 

Monitoring pharmaceutical ingredients, water for pharmaceuhcal purposes, the manufacturing environment, and finished products submitted to the laboratory to demonstrate control of microbial contamination of the pharmaceutical products manufactured... 

Quality and productivity improvement share a common element-reduction in variability through process understanding. Reducing variability provides a win-win opportunity from both public health and industry perspectives. And, since pharmaceutical product manufacturing technologies and practices are generally similar between both innovator and generic... 

Process data are provided by the end user and include critical process data that are generated from, or with reference to, the end user s pharmaceutical product manufacturing specifications. 

National legal provisions on who should manufacture, import or supply pharmaceutical products, what qualifications people in the supplying agency should have, and who should dispense and sell pharmaceutical products. manufacture (manufacturing)... 

The relation between the batch size for investigational pharmaceutical products manufactured in a pilot plant or small-scale facility to the planned full-size batches may vary widely depending on the pilot plant or pharmacy batch size demanded and the capacity available in full-size production. 

Article 1 of the Pharmaceutical Inspection Convention provides that Contracting states shall exchange such information as is necessary for the mutual recognition of inspections relating to the pharmaceutical products manufactured within their territories and intended for import into other contracting States. 

Biological pharmaceutical products manufactured by these methods include vaccines, immunosera, antigens, hormones, cytokines, enzymes and other products of fermentation (including monoclonal antibodies and products derived from r-DNA). 

HME technology is an increasingly attractive process for the manufacturing of pharmaceutical dosage forms. Pharmaceutical products manufactured via HME have been approved in the United States, Europe, and Asia. Over the last three decades, patents related to pharmaceutical systems prepared by HMT have steadily increased. The United States and Germany hold approximately 56% of all issued patents for HME worldwide. ... 

Occurs in the high-boiling fraction of coal tar. Most conveniently prepared by Skraup s reaction by healing a mixture of aniline, glycerol, sulphuric acid and nitrobenzene. Used in the manufacture of dyestuffs, and pharmaceutical products. 

Human blood plasma contains over 700 different proteins (qv) (1). Some of these are used in the treatment of illness and injury and form a set of pharmaceutical products that have become essential to modem medicine (Table 1). Preparation of these products is commonly referred to as blood plasma fractionation, an activity often regarded as a branch of medical technology, but which is actually a process industry engaged in the manufacture of speciaUst biopharmaceutical products derived from a natural biological feedstock (see Pharmaceuticals). 

Pharmaceutical. Ion-exchange resins are useful in both the production of pharmaceuticals (qv) and the oral adrninistration of medicine (32). Antibiotics (qv), such as streptomycin [57-92-17, neomycin [1404-04-2] (33), and cephalosporin C [61-24-5] (34), which are produced by fermentation, are recovered, concentrated, and purified by adsorption on ion-exchange resins, or polymeric adsorbents. Impurities are removed from other types of pharmaceutical products in a similar manner. Resins serve as catalysts in the manufacture of intermediate chemicals. 

Carotenoids are also used as pigments and dietary supplements in animals and poultry feedstuffs. They are added to pharmaceutical products to provide a form of control during manufacturing and to distinguish one product from another. They also enhance the aesthetic aspects of the products (210). 

Pharmaceutical Products. Rhc ne-Poulenc offers a flaked technical-grade vanillin, Vaniltek, to be used in pharmaceutical appHcations. The single largest use for vanillin is as a starting material for the manufacture of an antihypertensive dmg having the chemical name of Methyldopa or L-3-(3,4-dihydroxyphenyl)-2-methylalanine. 

Benzylarnine, [100-46-9] CgH CH2NH2 (bp, 184°C at 101.3 kPa) produced by reaction of ammonia with benzaldehyde and hydrogenation of the resulting Schiffs base, is used as the raw material for the production of biotin (Vitamin H), as an intermediate for certain photographic materials, and as an intermediate in the manufacture of certain pharmaceutical products. 

Fine chemicals There are many applications of the austenitic steels in the manufacture and storage of fine chemicals and pharmaceutical products. These include storage tanks, pipelines, valves, stills, steam-jacketed pans, mixing vessels, filters and tableting machinery. Considerable use has been made of these steels in penicillin production. 

Thio-4-oxoselenazolidines substituted in the 3-position, have been described in a number of patents, (79. 80). They are used as intermediates in the manufacture of pharmaceutical products and color sensitizers in photography. They are obtained by action of isothiocyanates on a-hydroselenoacetic acid in the presence of strong base and in the absence of air (Scheme 77). 

At its core, each manufacturer must have a QA system appropriate to the manufacture of pharmaceutical products. Essential elements that such a system should address are summarised in Figure 11.6. 

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

Pharmaceutical microbiology may be defined as that part of microbiology which has a special bearing on pharmacy in all its aspects. This will range fiom the manufacture and quality control of pharmaceutical products to an understanding of the mode of action of antibiotics. The full extent of microbiology on the pharmaceutical area may be judged fiom the chapter contents. 

The first chapter in this section provides a unique account of the ecology, i.e. distribution, survival and life-style, of microorganisms in the factory environment, and should enable process designers, controllers and quality control personnel to comprehend, trace and eradicate the sources of failure due to extraneous microbial contaminants in the finished product. Much of the information given here is applicable to hospital manufacture also, and this is extended in a contribution (Chapter 19) dealing with contamination in hospital pharmaceutical products and in the home. 

Compressed air has many applications in the manufacture of pharmaceutical products. 

Pharmaceutical products are used in a variety of ways in the prevention, treatment and diagnosis of disease, hi recent years, manufacturers of pharmaceuticals have improved the quality of non-sterile products such that today the majority contain only a minimal microbial population. Nevertheless, a few rogue products with an unacceptable level and type of contamination will occasionally escape the quality control net and when used may, ironically, contribute to the spread of disease in patients. 

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