Solvent extraction seems to have great potential in the field of wastewater treatment, both for the economical recovery of valuable materials and for their disposal in accordance with legal requirements. The Phenox process removes phenol from catalytic crack wastewater in oil refineries. Extraction methods may show a slight gain in the value of phenols extracted from ammonium coke oven lye. Oils are obtained by extraction from oily effluents from petroleum and petrochemical plants. Solvent extraction is used commercially to recover valuable by-products of effluents generated in the wool industry and is used in the same way in the pharmaceutical industry. Several solvent extraction systems have been reported for organic treatment of industrial wastewater. The additional items included in the organic quality system regulations set out in 21 CFR 610 relate to products defined as organic and would therefore include products other than HCT/Ps specifically addressed in this document. The Center for Biologics Evaluation and Research (CBER) regulates a variety of product types, including allergens, blood and blood products, cell and gene therapies, tissues and tissue products, vaccines, and xenotransplantation products. The CBER also regulates certain devices, including some in vitro diagnostics and devices that manufacture a biologic at the point of care, as well as a small number of drugs related to blood banks or cell therapies.
This means that not all «organic products» are treated equally; The manufacturer must determine which elements of 21 CFR 610 are appropriate for the products it manufactures. For example, 21 CFR 610.53, dating periods for whole blood and blood components, is specific to blood products and would not be required for a company developing a stem cell-based therapeutic product. Because products in the field of tissue engineering and regenerative medicine are so diverse, it may be easier to understand GMP and quality requirements if the products are divided into two main categories, (1) human tissue products and (2) cellular technologies, which are studied separately. If something is required by law, it is affiliated or established by laws or statutes. Legal restrictions on air pollution require motorists to have their car`s emissions checked every few years. RBAC systems meet administrative and legal requirements for privacy and data protection because executives and IT offices can more effectively manage the data accessed and used. The regulations themselves are often drafted at such a high level that the specific requirements for many areas of activity specific to organic products and HCT/P may not be clear. Therefore, cell-based products must also be based on a large number of standards and guidelines. FDA «guidance documents» are not an extended form of legislation like regulations are and, therefore, in principle, do not have to be followed to comply with a law.
However, guidance documents outline current FDA considerations on a topic and should be considered recommendations, unless specific regulatory or legal requirements are cited. The use of the word «should» in an FDA guideline implies that an activity or approach is suggested or recommended, but not mandatory. Essentially, a guidance document is used by the FDA to express its current thoughts on an issue and make recommendations on how a company might comply with the regulations. Therefore, all guidance documents issued by the FDA include a box with the following statement on the page immediately following the table of contents. In addition to legal financial reporting requirements, audits of accounting and financial management practices often examine accounting policies used by different organizations to validate the appropriateness of the approaches used and verify information such as asset valuation or cost allocation. Many financial practices involve estimating costs or assigning value to organizational assets, particularly fixed assets that are reported as an expense on balance sheets. Asset valuation is also an important step in quantitative risk assessment, as companies need to know the value of the assets they hold and the costs incurred by the organization if those assets are lost, stolen or otherwise compromised – in order to determine the level of safeguards to implement. Cost accounting for financial assets provides an independent review of resource cost allocation and asset valuation, possibly including comparing an organization`s cost approach with industry or market standards or relevant third-party cost data. The primary objective of this type of financial audit is to ensure that the assets and costs allocated are accurate, consistent and adequately supported by evidence. In some cases, this type of audit overlaps with operational audits (described later in this chapter), at least to the extent that the functional breakdown of organizational activities includes information on cost allocation. For example, organizations that use activity-based costing in their approach to financial management and accounting first identify all the activities they perform and then measure the resource utilization associated with each activity used to determine its costs. The accuracy of these accounting methods depends on an organization`s ability to correctly and consistently calculate the direct and indirect costs of resources, including assets such as IT equipment, raw materials, hardware, software and infrastructure.
Organizations that delegate some or all of their internally managed IT operations to external service providers often need to modify their cost accounting methods to adequately reflect processes and activities that use infrastructure, hardware or other resources that do not belong to the organization.