Comprehensive Compliance

All regulatory inspections must be analyzed by the compliance department to determine the main areas for GMP enhancement. An action plan or GMP enhancement master plan should then be designed to correct all deficiencies—and not only those cited in an FD-483. (For a detailed discussion of this subject, refer to Chap. 16, The Compliance Upgrade Master Plan) Subsequent internal quality assessments should initially focus on areas identified during the regulatory inspection and use the FD-483 as a platform from which to launch a comprehensive compliance and quality upgrade master plan. 

Commitment to and execution of a comprehensive compliance upgrade master plan. (For an extensive discussion on the compliance upgrade master plan, see Chap. 16, The Compliance ETpgrade Master Plan. )... 

Chemical Process Safety Report—News and Analysis on Regulation of Chemical Process Safety and Accident Prevention, Thompson Publishing, Washington D.G., (202) 872-4000 or (800) 677-3789. The Chemical Process Safety Report is a comprehensive compliance manual covering OSHA s PSM standard. The publisher updates this howto manual on a monthly basis. The annual subscription includes a valuable indexed ref-... 

Gershey, E.L., Party, E., and Wilkerson, A. (1991) Laboratory Safety in Practice A Comprehensive Compliance Program and Safety Manual, Van Nostrand Reinhold. 

At a minimum, mining health and safety regulations play an important role. However, comprehensive compliance with all regulations is no assurance of an injury- and illness-free workplace. Therefore, regulations notwithstanding, it remains the responsibility of management and workers alike to strive for this goal. 

Under the Comprehensive Environmental Response, Compensation, and LiabiHty Act (CERCLA)/RCRA regulations in effect at the end of 1986 bromine is regulated as a hazardous waste or material. Therefore, it must be disposed of in an approved hazardous waste faciHty in compliance with EPA and/or other appHcable local, state, and federal regulations and should be handled in a manner acceptable to good waste management practice. The reportable quantity is 45.4 kg for corrosivity (62). 

Ensure that the contractor/subcontractor can implement a comprehensive health and safety program in compliance with applicable regulations, including accident prevention programs, medical surveillance, training, work practice controls, use of personal protective equipment, and so on. 

W. R. Acorn. Code Compliance for Advanced Technology Facilities A Comprehensive Guide for Semiconductor and Other Hazardous Operations. Park Ridge, NJ Noyes Publications, 199.3. 

Tests carried out on protection systems comprise factory tests, on-site commissioning tests and maintenance checks. Those made on individual relays will demonstrate the compliance of the equipment with specification and the verification of its operation under simulated conditions, while tests carried out on-site prior to the equipment being put into service ensure that the full protection scheme and associated equipment operate correctly. These on-site tests must be comprehensive and should include ... 

Emissions from hazardous waste combustors are regulated under two statutory authorities RCRA and the CAA. The MACT standards set emission limitations for dioxins, furans, metals, particulate matter, total chlorine, hydrocarbons/carbon monoxide, and destruction and removal efficiency (DRE) for organics. Once a facility has demonstrated compliance with the MACT standards by conducting its comprehensive performance test (CPT) and submitting its notification of compliance (NOC), it is no longer subject to the RCRA emission requirements with a few exceptions. RCRA-permitted facilities, however, must continue to comply with their permitted emissions requirements until they obtain modifications to remove any duplicative emissions conditions from their RCRA... 

Analyses of developed countries e-waste management shows Japan to have perhaps the best-functioning system, in terms of scope and compliance levels. Korea, Canada, and Australia have well-advanced systems as well. Switzerland s system is seen as a model of comprehensive management, and the Swiss, Norway, Belgium, Sweden, and the Netherlands have all exceeded minimum EU e-waste directives collection and recycling targets. 

OSHA IMIS Records of workplace inspections, including those prompted by accidents where a worker is injured 1984-Present Information from OSHA field inspections, a third party More accurate description of impacts on employees and contractors Keyword indexing allows for easy search and retrieval Not comprehensive, limited to incidents selected by OSHA Inspections without abstracts cannot be keyword searched causal information unavailable Designed to assist compliance enforcement, not to report on incident causes Limited information from State-Plan states Not designed to be a lessons-leamed database... 

EPA ARIP Responses to questionnaires sent by EPA from facilities that have had significant releases purpose is to learn about causes and consequences of hazardous material incidents 1986-Present Supplements NRC reports for more significant events Additional information on causal factors, consequences, and company safety programs Data are easily analyzed for common causes Includes all states and localities Survey relies on voluntary compliance Not comprehensive limited to select cases Checklist approach limits value of information to understand root cause Not designed to be a lessons-leamed database... 

Naltrexone is prescribed at a dose of 50 mg once per day for at least 12 weeks as part of a comprehensive alcohol treatment program. Like all treatments for substance use disorders, it works only as well as the addict allows it to work. This is why it is important to use it as a component of an overall treatment plan. Otherwise, poorly motivated alcohol abusers will seldom remain adherent with naltrexone and it will have little chance of providing benefit. A long-acting depot formulation of naltrexone currently in development might improve these compliance problems. 

In its 1984 policy statement, FDA stated that until some form of regulatory control was instituted, new versions of these drugs could be marketed only if the new version was in all significant respects identical to the old version. The life of one of these products is, of course, imcer-tain. FDA could at any time decide to regulate any or all of these products in a more comprehensive way. FDA announced a new draft Compliance Pohcy Guide in October 2003 that confirmed... 

Could regulators conduct their own audits, not depending upon validation by laboratories In theory that strategy could be successful, but two problems stand in the way. First, resources, including time and expertise, permit only a very cursory spot check on compliance. Those limited resources are much better spent in reviewing comprehensive validation reports than in conducting very limited tests of system performance and compliance. 

The initial assessment begins to establish the therapeutic alliance between the physician and the family. A working partnership with the parents and with the youngster is essential for comprehensive treatment and for compliance. The physician should be a collaborator with the child and family to empower them to effect improvements in their lives. Within this therapeutic alliance, the psychological power of medication treatment needs to be considered (see Chapter 33) to avoid the pitfall of assuming that medication alone will independently transform the identified problems. 

---