Agency requirements

An agency requires, either within its own organization or readily available from other organizations, provision of the following administrative support funcbons ... 

EPA (2001) Environmental Protection Agency. Requirements for quality assurance project plans for environmental data operations (EPA QA R/5)... 

The fluids can be hauled by vacuum tmcks to an approved disposal site for such wastes. There are different classes of disposal sites. If regulatory agencies require that a fluid be disposed in a hazardous waste secure landfill, the cost would be very high. 

Many local regulatory agencies require the ESP to be energized whenever the FCC main blower is in operation. Some units have found that steam/moisture injection is useful at temperatures lower than 400°F as a form of resistivity modification. This is because the unit is in the surface conduction phase of the resistivity curve. At this temperature, the moisture improves surface conduction of the particles. 

Allergic reactions to ESAs have been infrequent. There have been a small number of cases of pure red cell aplasia (PRCA) accompanied by neutralizing antibodies to erythropoietin. PRCA was most commonly seen in dialysis patients treated subcutaneously for a long period with a particular form of epoetin alfa (Eprex with a polysorbate 80 stabilizer rather than human serum albumin) that is not available in the USA. After regulatory agencies required that Eprex be administered intravenously rather than subcutaneously, the rate of ESA-associated PRCA diminished. However, rare cases have still been seen with all ESAs administered subcutaneously for long periods to patients with chronic kidney disease. 

The U.S. Environmental Protection Agency requires that MTBE or other oxygenates be added to gasoline in certain areas of the U.S. during the winter to reduce emissions of carbon monoxide. 

A final impact of the protocol is pertinence. It allows for administrative review to ensure that the study, as designed and described, pertains to the needs at hand and that the result will not only meet the stated study objective but also fulfill regulatory agency requirements. 

Microfiltration is used widely in the pharmaceutical industry to produce injectable drug solutions. Regulating agencies require rigid adherence to standard preparation procedures to ensure a consistent, safe, sterile product. Microfiltration removes particles but, more importantly, all viable bacteria, so a 0.22- xm-rated filter is usually used. Because the cost of validating membrane suppliers is substantial, users usually develop long-term relationships with individual suppliers. 

Computer systems are validated for two important reasons to ensure that good business practices are followed, and to satisfy regulatory agency requirements. 

The reasons for satisfying regulatory agency requirements include ... 

Impact of change The impact of change is the effect of change on the GxP computerized system. The components by which the impact of change is evaluated may include, but not be limited to, business considerations, resource requirements and availability, application of appropriate regulatory agency requirements, and criticality of the system. 

The agency requires that all FDA-regulated industries conduct quality assessments. It is up to each particular industry (pharmaceuticals medical devices, biologies, etc.) to comply with this expectation by designing programs that meet the company s quality and compliance standards. 

---