Reduced regulatory requirement

There are no additional or reduced regulatory requirements for closing sites. Computer systems should be maintained in a validated state of compliance up until the very last day of their operational life. GxP records must be archived and stored for the required retention periods. Archived records should be readily retrievable to support critical quality operations like recall, customer complaints, and batch investigation. Computer systems should then be decommissioned, as discussed later in this chapter. Some computer systems may be disassembled and sent for installation at other sites as part of a program of drug product transfers. 

There is an apparent gray area for certain low molecular weight polymers that are often collectively referred to as oligomers. The term oligomer has no significance in the determination as to how a substance should be notified in Canada, a substance is a polymer or it is a chemical. Certain polymers are characterised as requiring reduced regulatory requirement (RRR) polymers, and these new... 

Type of polymer a reduced regulatory requirement (RRR) polymer... 

Research investigators should be aware of the ethical, legal, and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal, or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration. 

Requires FDA to support the office of the US Trade Representative to reduce the burden of regulation and harmonise international regulatory requirements consistent with the purposes of the FD C Act. 

The U.S. Department of Energy (DOE) is researching technologies for the stabilization and immobilization of fly ash contaminated with radionuclides and metals that will reduce waste material volume and consistently satisfy regulatory requirements. The Mixed Waste Focus Area (MWFA), a DOE/EM-50 program, has stated the need for improved stabilization methods that would accept higher ash waste loadings. To address these issues, the MWFA has invested in a sintered ceramic stabilization technique developed by Clemson University. 

The formation of isocyanurates in the presence of polyols occurs via intermediate allophanate formation, i.e, die urethane group acts as a cocatalyst in the dimerization reaction. By combining cyclotrimeiization with polyurethane formation, processibility is improved, and the friability of the derived foams is reduced. Modification of cellular polymers by incorporating amide, imide, oxazolidinone, or carbodiimide groups has been attempted but only the urethane-modified isocyanurate foams are produced in the 1990s. PUIR foams often do not require added fire retardants to meet most regulatory requirements. A typical PUIR foam formulation is shown in Table 2. 

---