Production and quality control

The manufacture of the new drug must be carried out under the conditions laid down in the marketing authorization (MA) (see section 11.8). Since it is not usually practical for manufacturers to dedicate a plant to the production of one 

The clips are manufactured from Du Pont Delrin 500 acetal copolymer resin. This is a general moulding grade. 

The process is injection moulding, using an eight-impression tool, with hot runners to minimize scrap. No reground material is permitted. 

The injection moulding machine is an 80-ton clamp Negri-Bossi. Temperatures in plasticizing and injection sections are 185 C. The mould cooling water is at 70°C. 

The essential quality control tests check that, (a) the correct shot size has been injected and (b) the correct thermal conditions have been observed. 

If the shot size is deficient, or the temperatures too low, the polymer will not develop its full strength properties, and a brittle moulding will result. 

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E. Flanigan, Fligh Performance Eiquid Chromatography in the Production and Quality Control of Salmon Calcitonin, Purdue University, West Lafayette, Ind., 1991, p. 207. 

Committee For Proprietary Medicinal Products, Xotes to Applicants for Marketing Authorisations on the Production and Quality Control of Monoclonal... 

Organisation chart showing the arrangements for quality assurance, including production and quality control. 

The company was a private label manufacturer of home maintenance and personal care products. Its laboratory would be involved with new product development, evaluation of raw materials, testing of competitive products, and quality control. Laboratory personnel would also be responsible for chemical safety in the plant and for proper waste disposal. 

Applications X-ray fluorescence is widely used for direct examination of polymeric materials (analysis of additives, catalyst residues, etc.) from research to recycling, through production and quality control, to troubleshooting. Many problems meet the concentration range in which conventional XRF is strong, namely from ppm upwards. Table 8.42 is merely indicative of the presence of certain additive classes corresponding to elemental analysis element combinations are obviously more specific for a given additive. It should be considered that some 60 atomic elements may be found in polymeric formulations. The XRF technique does not provide any structural information about the analytes detected the technique also has limited utility when... 

ITMs provide a valuable service to all phases of tablet manufacture, from research to production and quality control [109 111]. As a research tool, ITMs allow in-depth study of the mechanism of tablet compaction by measuring the forces that develop during formation, ejection, and detachment of tablets. ITMs can also provide clues about how materials bond,... 

T. Inada and T. Fukuda, Direct Synthesis and Growth of Indium Phosphide by the Liquid Phosphorous Encapsulated Czochralski Method O. Oda, K. Katagiri, K. Shinohara, S. Katsura, Y. Takahashi, K. Kainosho, K. Kohiro, and R. Hirano, InP Crystal Growth, Substrate Preparation and Evaluation K. Tada, M. Tatsumi, M. Morioka, T. Araki, and T. Kawase, InP Substrates Production and Quality Control... 

Advances in instrumentation, such as diode arrays and ruggedized interferometers, have made IR and Raman instruments readily available for process work. NIR hardware has always been used more for production and quality control than laboratory and research work. They, too, have become smaller, faster, more rugged and, in 1980s dollars, less expensive. Explosion-proof enclosures allow close proximity to reactors containing solvents and can be operated in dusty locations (raw material handling situations). 

Expert systems, however, have their disadvantages. Perhaps the most significant one is that it is hard to prove rigorously that they will not give an unexpected behavior. This causes production and quality control organizations to be reluctant to adapt to the methods. Writing a specification for expert system control is less exact and, therefore, more difficult to adapt to quality control methods that were developed for time-temperature-based plans. The... 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

It is the responsibility of all departmental managers or supervisors (production and quality control) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance. 

Catty, D. and Raykundalia, C. (1988) Production and quality control of polyclonal antibodies, in Antibodies vol. 1—A Practical Approach (Catty, D ed.), 1RL, Oxford. 

More than seventy elements may be detected by standard procedures. Atomic gases, such as O, N, H, He. Ar, Ne, Kr, Xe, and Rn and the halogens are excluded. Nonmetallic substances, such as C, S, and Se. require vacuum path specuometets foi optimum detection and measurement. Analytical ranges may extend from fractional parts per million to about 40% concentration. Computer-controlled photoelectric optical emission spectrometers will output printed percent concentrations for 30 to 50 elements per sample in just a few minutes. This form of analytical instrumentation is used widely in production and quality control, as well as for research studies. 

The method can be applied in foodstuff production and quality control of finished products, also in nutrient production. Application of the method offered is very simple. It can be realized both in discreet and... 

M. Soholic, B. Filipovic, and M. Pokorny, HPLC procedures in monitoring the production and quality control of chlortetracycline, J. Chromatogr., 509 189 (1990). 

As well as these general criteria there may be specific tests appropriate to specific products with regard to quality control. Therefore, each product s production and quality control should be considered independently, taking into account any special characteristic. The considerations for each product must also relate to its clinical use. Therefore, a preparation to be administered repeatedly over a long period of time or in large doses will probably need to be subjected to more stringent tests (particularly for antigenicity) than a product that is applied only once (e.g. a vaccine). 

Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised. 

K. Tada, M. Tatsumi, M. Morioka, T. Araki, and T. Kawase, InP Substrates Production and Quality Control M. Razeghi, LP-MOCVD Growth, Characterization, and Application of InP Material... 

Guideline on Production and Quality Control of Monoclonal Antibodies. Document III/5271/94 in Volume 3AB4a of the Rules Governing Medicinal products in the European Union, http //www.tga.gov.au/docs/pdf/euguide/vol3a/3ab4aen.pdf... 

Concept paper on the need to revise the guideline on production and quality control of monoclonal antibodies. CHMP/BWP/64/04,21 October 2004. http //www. emea.eu.int/pdfs/human/bwp/006404en.pdf... 

European Medicines Evaluation Agency (EMEA) Guideline. Production and Quality Control of Monoclonal Antibodies, Directive 75/318/EEC, 1995. http // www.q-one.com/guidance/emea.htm... 

Committee for Proprietary Medicinal Products (1991). EEC Regulatory Document Note for Guidance Production and quality control of cytokine products derived by biotechnological processes. Biologicals 19, 125-131. 

Production and quality control of monoclonal antibodies of murine origin (7/1987)... 

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