Quality control and regulation

Any person working within the pharmaceutical industry or allied/support industries in a scientific capacity will be well aware that a good deal of their everyday work requires conformance to quality standards dictated by various regulatory bodies. For a scientist coming directly from university into the industry, there may weU be some culture shock and bewilderment caused by the plethora of standards and procedures that require to be followed as part of their job. Additionally, it may be disturbing to discover that non-compliance with these quality standards and regulatory requirements could result in severe penalties for their employer and loss of their own job. 

We shall concentrate on the area of new chemical entities (NCEs) rather that new biological entities or biopharmaceuticals. These latter materials are governed by very similar regulations and quality requirements, but are somewhat outside of the experience of the author. The focus will be on regulatory requirements in the USA and Europe. 

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Parenteral Drug Association (PDA). 3 Bethesda Metro Center, Suite 1500, Bethesda, MD 20814, U.S.A. Phone +1 301-656-5900, Fax +1 301-986-0296. E-mail info pda.org. URL http //www.pda.org. PDA is a non-profit international association of more than 10,500 scientists involved in the development, manufacture, quality control, and regulation of pharmaceuticals/biopharmaceuticals, and related products. The association also provides educational opportunities for government and university sectors that have a vocational interest in pharmaceutical/biopharmaceutical sciences and technology. The association publishes the PDA Journal of Pharmaceutical Science and Technology. It holds an annual meeting and sponsors several symposia and educational programs. 

The control and regulation of indoor air quality are influenced by individual property rights and a complicated mosaic of federal, state, and local government jurisdiction with conflicts, overlaps, and gaps in addressing these issues. Table 23-3 shows a large number of agencies and departments involved in indoor air quality control efforts at the federal level. 

Research use of analytical results in the framework of a nonanalytical setting, such as a governmental investigation into the spread of pollution here, a strict protocol might exist for the collection of samples (number, locations, time, etc.) and the interpretation of results, as provided by various consultants (biologists, regulators, lawyers, statisticians, etc.) the analytical laboratory would only play the role of a black box that transforms chemistry into numbers in the perspective of the laboratory worker, calibration, validation, quality control, and interpolation are the foremost problems. Once the reliability and plausibility of the numbers is established, the statisticians take over. 

Hampton, R. Y. ER-associated degradation in protein quality control and cellular regulation. Curr Opin Cell Biol 2002, 34, 476-82. 

The production of the API and finished dosage form is required to comply with GMP regulations discussed in Chapter 9 and Section 10.2. The quality system, quality control, and validation of equipment and processes have to be developed and adhered to in the manufacturing process. Proper records and documentation are required to be kept in the forms of batch records. 

Rules and regulations for air quality control and/or solid waste disposal have been established for explosives in general. The regulations vary from state to state (1,3-DNB 1,3,5-TNB). 

This book tells the story of the ubiquitin system as we currently know it from the regulation of basic cellular processes to quality control and the pathogenetic mechanisms of disease, from X-ray crystallography of the 26S proteasome to the interaction between substrates and their ligases, to the development of mechanism-based drugs, and to target-specific aberrant processes. 

Quality control and assurance Final product must be made under current good manufacturing process (cGMP)— emphasis placed on the final bulk product The product is the manufacturing process —cGMPs from seed stock or first step onward evaluated with equal scrutiny Regulated under analytical procedures and method validation, chemistry, manufacturing and control (CMC) documentation... 

Simon JE. Domestication and production considerations in quality control of botanicals. In Eskinazi D, Blumenthal M, Farnsworth NR, Riggins CW, eds. Botanical Medicine - Efficacy, Quality Assurance and Regulation. Larchmont, NY Mary Ann Liebert Inc., 1999 133-137. 

Table E-5 contains a list of federal, state and local statutes, regulations and ordinances that are relevant to hazardous waste generators. The list includes requirements for raw material handling, waste disposal, air quality control, and discharges to sewers.

The readily excitable fluorescence or phosphorescence of phosphors can also be made use of in the automation, control, and regulation of automatic sorting processes, in packaging, or in quality control. 

Regulatory Affairs The FDA s Office of Regulatory Affairs is increasingly active in international standards activities relevant to quality control and conforming assessment, including activities relevant to ISO—9001 and laboratory regulation. 

Product testing is one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertains to the quality control and drug product testing. 

The use of chemical analysis to monitor the quality of the raw materials or finished products of industrial processes goes back a long way.313,314 Indeed, some techniques owe their development to the need of industry for rapid analytical techniques. However, analytical methods are now often intimately bound up with the production itself, and supply much of the information required for the control and regulation of the process.315 A good example of a continuous monitoring technique that can be used in process control is that of electrodeless conductivity measurement its history has been described.316 A history of early industrial pH measurement and control systems has been given.317... 

With the use of microprocess technology, the fluorination with DAST can be performed under decomposition conditions in continuous-flow mode [50], Temperatures of 90-100 °C and reaction times of 60-120 min are necessary for high conversions in order to compensate for the slow intrinsic reaction rate. A continuous quality control allows regulation of the process parameters (PAT, process analytical technology). A throughput of 5-10kg/day using three parallel modules was achieved. 

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