COMPLIANCE STATUS

The specific requirements to complete the NSR process will vaiy depending on the source location and characteristics, the federal and state regulations which apply, the compliance status of the facihty if it is existing, and the nature of other sources in the area. Atmospheric dispersion modehng is often necessary to determine the maximum offsite ambient air concentrations of the various pollutants that will be... 

These regulahons will apply to an estimated 34,000 "major" industrial sources. "Major" sources are defined according to their "potential to emit" and the cutoff levels vary depending on both the pollutant and the local areas compliance status with the National Ambient Air Quality Standard (NAAQS) for that pollutant. For the present, the EPA has exempted all "nonmajor" sources, of which there are estimated to be about 350,000, from this permithng, unhl they have studied further the feasibility of permithng them. However, the states can require permitting of some of these sources. 

CHCS Compliance Engine Advanced Systems Laboratories, Inc. 7137 West Main St. Lima, NY 144SS (716) 624-3276 Assists with SARA Title 111 compliance. User inputs information and system provides compliance status and tasks required for compliance. 

The facility periodically reviews its compliance status to assure that the programs which have been implemented are operating as designed. 

Overall compliance status and history of the company or facility... 

Compliance Status of Major Air Pollution Facilities, U.S. Environmental Protection Agency, Office of General Enforcement, Washington, D.C. (November, 1977). 

During a GLP inspection of a facility by the EPA, the inspectors usually examine SOPs and may check the items outlined below to determine the compliance status of the system. Commonly, inspectors request copies of SOPs to include them in the inspection report in support of their observations. 

Evaluate regulatory compliance status of all facilities providing clinical and nonclinical testing as well as manufacturing facilities... 

Center for Biologies Evaluation and Research. Manual of Standard Operating Procedures and Policies, SOPP 8407. Compliance Status Checks, Dec. 13,1996. 

The risk associated with not performing site follow-up visits is that any corrections that maybe needed will not occur in atimely manner. Expanding the initial scope of work due to late identification of deficiencies will inevitably delay the project and possibly jeopardize its overall compliance status. 

Inform management of compliance status, regulatory risk, and civil liability... 

There is difficulty in measuring compliance status against emerging trends and expectations. 

Provides executive management with a clear picture of the overall compliance status of each system or procedure Process-gap-analysis rating system provides a quantifiable assessment Corrective actions presented to bring system back to a 100% compliance status... 

WHAT IS YOUR COMPANY S CURRENT COMPLIANCE STATUS ... 

This focus helped field investigators conduct more effective, efficient, and comprehensive inspections of medical device manufacturers by evaluating key elements of a firm s overall quality system and compliance status. This new and improved inspection approach also led to an unprecedented number of administrative, regulator, and judicial actions against the medical device industry. 

When corrective and preventative actions are consistently minimalist and not concise, the results will eventually be reflected in product quality and in the firm s compliance status. Additionally, many problem, can arise when corrective and preventative actions are installed and presumed to be absolute without a short-and long-term assessment of the action. It is important not to assume that the CAPA installed today is necessarily the best practice or solution over the long haul. A long-term review of the CAPA will be the best indicator of its long-term viability. 

A periodic evaluation of the long and short-term effects of selected CAPAs or overall CAPA trends can reveal valuable information about a company s quality and compliance status and could provide an indication of product quality for any given period, once again allowing for decisions to be made about future product release activities. 

In recent years, the industry and FDA have evidenced the impact substandard laboratory practices, rampart OOS data, and lack offorward quality in the laboratory has had on marketed products, attempts to commercialize new products, overall company credibility, and compliance status. 

Periodically evaluate the quality and compliance status of the organization, regardless of the stage of product development or commercialization it is in. 

Once again, this importance of an effective management review system that provides continuous, up-to-date, comprehensive, and concise information about the company s overall compliance status is clear in light of the possible regulatory ramifications. In the event that a company has failed to... 

Summary, conclusions, and overall compliance status for the given platform/network/architecture should be documented, as well as a detailed description of each area of noncompliance. For each noncomphance, the nature of the remediation as well as the associated estimated completion date should be documented. If the remediation is longer term, the interim stopgap measure that will be taken should be documented. Finally, and perhaps most importantly, the person accountable for the remediation action must be documented. 

Periodic review — these should be conducted at least annually and are intended to evaluate the current compliance status of the system and identify any need for any system revalidation due to an accumulation of changes to the system or its functionality. 

If a facility conducts nonclinical laboratory studies, it is a testing facility and is subject to inspection by the FDA to determine its GLP compliance status. If a facility conducts nonclinical laboratory studies as well as studies that do not meet the definition of nonclinical laboratory study, then only those portions of the facility that conduct nonclinical laboratory studies are subject to a GLP inspection by the FDA. The portions of the facility that conduct studies other than nonclinical laboratory studies are not subject to inspection by the FDA unless the FDA has inspectional authority under some other set of regulations. 

Regular inspections of test facility to assess compliance status. 

The second responsibility may again be seen as dictated by self-interest. Since the sponsor should commission a GLP-compliant study, it lays squarely in his responsibility to ensure that the test facility to be chosen for the conduct of the study should indeed be able to perform the study under the conditions of the GLP Principles. Furthermore the requirement that the study should be conducted under GLP should certainly be fixed in the contract between sponsor and the test facility, i.e. the CRO. However, for assessing the ability of a test facility to conduct a study in compliance with GLP, the sponsor would be ill advised to rely solely on the assurances of the test facilities contacted for the possibility to perform such studies. The sponsor should either monitor the selected CRO prior to the initiation of the study, or the respective National Compliance Monitoring Authority may be contacted to determine the current GLP compliance status of the test facility. 

In the second case, the question of whether the sponsor performing the analyses would indeed be in a position to generate these data under the provisions of the GLP Principles, the sponsor obviously has to be made aware of this requirement by the Study Director. The GLP Principles do burden the Study Director with the responsibility of ascertaining the GLP compliant conduct of the whole study. This responsibility implicitly includes - as has been explicitly stated in the respective OECD Consensus Document (OECD No. 8,1999) - that the Study Director should be aware of the GLP compliance status of any facilities or sites involved in the study. If a contract facility were not GLP compliant, the Study Director would have to indicate this in the final report. Therefore, in the event of an unsatisfactory answer from the part of the sponsor, the Study Director would have to exclude the performance of this analysis from the GLP statement, and it is then again up to the Receiving Authority to judge whether these data can be considered acceptable or not. 

GLP Compliance Status The level of adherence of a test facility to the GLP Principles as assessed by the (National) GLP Monitoring Authority. 

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