Compliance Requirements

Appendix B of the standard outlines a nonmandatory compliance section regarding hazard assessment and PPE selection. This Appendix outlines general guidelines for identifying, organizing, and analyzing sources of hazards and selection criteria for the appropriate PPE. 

Appendix B further describes suggested steps that employers can take when conducting a hazard assessment. According to the Appendix, a survey should include observations of employees and their relation to injury or illness that can occur from work areas where eye, face, head, foot, or hand protection may be necessary to prevent injury from any of the following hazard sources  

After the hazard assessment has been conducted and the data has been collected, it should be organized in a logical outline that will estimate the potential for employee injury The organized data will help to decide the type of hazard(s) involved, the level of risk, and the seriousness of potential injury The appropriate levels of PPE are then selected based on the hazard determination and the availability of PPE. The user should be properly fitted for the specified PPE, and the employer should make sure that it is comfortable to wear. Hazard reassessments should be conducted as necessary based on the introduction of new or revised processes, equipment, and accident experience, to ensure the continued suitability of selection of the proper PPE. 

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Prior to beginning any training activity, exact training needs should be identified. Training needs may vary based on hazards, potential exposures, work requirements, roles and responsibilities, job descriptions, and compliance requirements. Job hazard analyses and employee surveys... 

The Secretary of Homeland Security determines which chemical facilities must meet the security requirements of DHS regulations based on the degree of risk posed by each facility. However, initially, screening of chemical facilities for compliance requirements was done on the basis of potential consequence rather than risk. 

Table 14-1 lists these requirements and provides a record of compliance for future analysis. Requiring completion of this record for each process incident investigated enhances the probability that all elements are covered. Auditing of incident reports against these requirements provides the forum for continuous improvement in meeting compliance requirements. 

T raining T/F T/F Training was available, timely (initially and in reviews) adequate and verified to be effective to achieve functional and compliance requirements... 

The Foundation is committed to complying with the laws regulating charities and charitable donations in all 50 states of the United States. Compliance requirements are not uniform and it takes a considerable effort, much paperwork and many fees to meet and keep up with these requirements. We do not solicit donations in locations where we have not received written confirmation of compliance. To SEND DONATIONS or determine the status of compliance for any particular state visit http //www.gutenberg.net/fundraising/pglaf... 

Good Laboratory Practice 58.105(a) requires that all test articles be appropriately characterized. Compliance requires documentation that characterization has been done. The tests conducted to provide this documentation, however, are not GLP-regulated, although such tests wiU in many instances be subject to CGMP standards (e.g., when the test article will also be used in human clinical studies). 

The rationale for bringing a new instrument into the laboratories should be well founded. The benefits of acquiring the instrument, such as increasing productivity, meeting a specific need or regulatory compliance requirements, or enhancing the capability of the laboratories, should justify the expenditure of valuable resources required to bring the instrument in house and to support its operation. 

Requires a commitment on the part of the purchaser to an external audit for GMP and/or ISO 9000 compliance Requires more internal quality control on the part of the purchaser beyond certificate of analysis acceptance... 

Providing documented evidence to achieve and maintain the validated status and uphold GMP compliance requires a systematic approach and rigorous controls throughout all phases of the computer system validation life cycle. Formal testing at key stages in the life cycle will provide records to demonstrate that predefined requirements have been met and that the computer system is fully documented. 

This Professional Edition of a pragmatic guide is designed to enlighten the industry at large, which suffers somewhat from the confusion created by earlier guidance documents now withdrawn. Written by an international expert in computer software and computer validation, it will become a classic of its kind when properly used to help companies implement their compliance requirements to meet the FDA and the MCA. 

Use of conservation tillage was one of the primary ways United States farmers met Conservation Compliance requirements of the 1985 Farm Bill. More than 75% of conservation plans for fields with Highly Erodible Land mandated some level of crop residue cover achievable through the use of conservation tillage. 

Compliance Requirements During the Drug Development Process... 

For an extensive discussion regarding compliance requirements during clinical activities, refer to Chap. 3, Role of Quality Assurance Throughout Clinical Trials. ... 

Some of the measures used to keep a facility in compliance require a firm to... 

The appropriate signatory to meet compliance requirements would be the director of quality control. Additional signatures from quality assurance are not necessarily required but would provide an opportunity for regulatory oversight. 

The goal of this chapter is to provide an understanding of the overall stability study process and its corresponding compliance challenges. It is hoped that such an understanding will result in stability studies that not only meet all regulatory and compliance requirements, but also improve and increase the assurance of the quality of the marketed product. 

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