Regulatory manufacturing

Laurence J Craigie, B S>Chem. Composite Resources, LLC industry consultant in regulatory, manufacturing, and business needs for the composite industry Member, American Society of Mechanical Engineers (Chairman RTP Corrosion Resistant Equipment Committee) Member, American Society of Testing and Materials Member, National Association of Corrosion Engineers International Member, Composite Fabricators of America (received President s Award) (Reinforced Thermosetting Plastie)... 

The creation of a process to meet FDA requirements is a multidisciplinary activity. Although the Chemical Process Development organization generates the core process, its shaping and implementation to meet the needs of all other parties involved (particularly Regulatory, Manufacturing, Pharmaceutical Sciences, and Quality Assurance) requires an extraordinary level of collaboration. The principal objective is to produce, and to demonstrate that you have indeed produced, a high-quality API in a well-controlled system of operations. 

Handbook of Biogeneric Therapeutic Proteins Regulatory, Manufacturing, Testing and Intellectual Property Issues, Taylor and Francis, Boca Raton, PL 2005. 

The use of these techniques is an important element of industrial policy since they contribute to the creation of a business friendly regulatory environment allowing the combination of measures taken for internal organisational reasons and obligations of certification without lowering the level of safety to be achieved. Wlienever possible a choice between product control and quality assurance procedures is offered to manufacturers. 

In the late 1980s attempts were made in California to shift fuel use to methanol in order to capture the air quaHty benefits of the reduced photochemical reactivity of the emissions from methanol-fueled vehicles. Proposed legislation would mandate that some fraction of the sales of each vehicle manufacturer be capable of using methanol, and that fuel suppHers ensure that methanol was used in these vehicles. The legislation became a study of the California Advisory Board on Air QuaHty and Fuels. The report of the study recommended a broader approach to fuel quaHty and fuel choice that would define environmental objectives and allow the marketplace to determine which vehicle and fuel technologies were adequate to meet environmental objectives at lowest cost and maximum value to consumers. The report directed the California ARB to develop a regulatory approach that would preserve environmental objectives by using emissions standards that reflected the best potential of the cleanest fuels. 

Sweeteaer lateasity Developer and/or manufacturer Regulatory status... 

Eour groups are involved in the production or use of motor fuels in the United States (/) manufacturers of the vehicles (2) manufacturers and/or marketers of the fuels (J) purchasers and users of fuels and vehicles and (4) federal, state, and local regulatory agencies (qv). Each has a different role. 

Establish Verification Procedures. Verification can be performed independently by the manufacturer and the regulatory agency to determine that the HACCP system within the plant is in compliance with the HACCP plan as designed. 

AppHcations of mercury include use in batteries (qv), chlorine and caustic soda manufacture (see Alkali and chlorine products), pigments (see Pigments, inorganic), light switches, electric lighting, thermostats, dental repair (see Dental materials), and preservative formulations for paints (qv) (1—3). As of the end of the twentieth century, however, increased awareness of and concern for mercury toxicity has resulted in both voluntary and regulatory reduction of mercury usage (see also Mercury compounds). 

Other L-amino acids are manufactured much more economically ia thousands of tons per year ia Japan by simplified fermentations direcdy from glucose, ethanol, acetic acid, glycerol, or / -paraffin, by means of selected auxotrophic, regulatory, and analogue-resistant bacterial mutants (94,95). 

Chemical Manufacturers Association, 1300 Wilson Blvd., Arlington, Va., 22209, (703) 741-5000, which offers information about Responsible Care (a registered trademark of CMA) and regulatory impact on the chemical industry. 

Synthetic Organic Chemical Manufacturers Association, 1100 New York Ave., N.W., Washington, D.C., 20005, (202) 414-4100, which offers information about regulatory impact on the chemical industry, particularly small and batch operations. 

PMA requirements differ between preamendment and post-amendment devices. Preamendment devices are those in commercial distribution before May 28, 1976 post-amendment devices are those first commercially distributed after the date. Class III post-amendment devices that are not substantially equivalent to preamendment Class III devices are considered new devices. Manufacturers of such devices are required to obtain PMA appHcation approval before marketing these. If the post-amendment device is substantially equivalent to a preamendment device and PDA has not initiated a regulatory process specifically requiring the submission of a PMA for the device category, a 510(k) submission can be made. 

Other U.S. regulatory clearances for sorbic acid allow its use as an antimicotic in the manufacture of food packaging materials (159), as a pesticide adjuvant when appHed to growing crops (160), and with methylceUulose and dimethylpolysiloxane as an antifoaming agent (161). 

Specialized training is an absolute requirement for technical service personnel. A typical example is a person involved in supporting a polymer for which the use is the manufacture of rotationaHy molded consumer products. The technical service person is expected to be reasonably familiar with topics such as polymer rheology evaluations, gel-permeation chromatography, rotational mol ding, color science, regulatory requirements for use, mechanical and photochemical behavior of the pigmented polymer, optics, and so forth. Expertise of this variety caimot be expected to be obtained without careful... 

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