Compliance Reviews

Process safety audits and compliance reviews Resolutions and close-out procedures... 

Audits and Corrective Actions—Items considered are process safety audits, maangement system audits and compliance reviews (criteria for intemal/extemal reviews and auditors for external/internal reviews), and resolutions and close-out procedures. 

First, the Office of Conformity Audit will conduct a compliance review to ensure that the dossier meets the standards of GCP, GLP and reliability. The GCP compliance check is based on the inspection of both study sites and sponsor. For the submission of new active substance usually four study sites are inspected. If the pivotal studies are conducted overseas, the inspection may be conducted by MHLW instead of PMDA. 

Conduct periodic compliance reviews as part of any contract renewal process. 

These standards originally concerned animal safety studies today, they are applied to all animal studies, for example, toxicology, pharmacology and animal PK. GLP was legalized as an MHLW Ordinance in 21 March 1997, requiring in particular to establish SOPs and the preparation of protocols and study reports. PMDA is conducting GLP compliance reviews and on-site inspections of testing facilities. 

The NDA is transmitted to the PMDA which first conducts a reliability and a GLP compliance review. When the data quality is confirmed, specialized team of experts review the NDA data and prepare a list of requests and questions addressed to the applicant. After receiving the answers from the applicant, a review report is prepared. Samples of the active principle might also be requested, for analytical control by the National Institute of Health Sciences. 

Determines drug therapy compliance Review of selected patient- ... 

Distribution risk management Compliance review and training Carrier safety Handling and storage Emergency preparedness... 

The operator s incident/accident experience and causal factors, complaints, legislative compliance reviews, and the operator s internal audit results The combined national experience of operators National and international trends and experience General industry experience and developing standards... 

Provide evidence of successful completion of the Driver-Training Program requirements in Part 380, Subpart B, when requested by employers and/or an authorized Federal Motor Carrier Safety Administration (FMCSA), state, or local official as part of a compliance review (The program must be for the operation of commercial motor vehicles (CMVs) representative of the subject matter he/she will teach.) ... 

Identifies drivers certified mder 380.401, when requested by employers and/or an authorized FMCSA, state, or local official in the course of a compliance review. 

Compliance Review — The FMCSA will conduct a compliance review on a Mexico-domiciled motor carrier within 18 months after the FMCSA issues the motor carrier provisional operating authority. 

The criteria used in a compliance review to determine whether a Mexico-domiciled motor carrier granted provisional operating authority under 365.507 exercises the necessary basic safety management controls are specified in Part 385, Appendix B. 

Satisfactory Rating — If the FMCSA assigns a Mexico-domiciled motor carrier a satisfactory rating following a compliance review, the FMCSA will provide the carrier written notice as soon as practicable, but not later than 45 days after the completion of the compliance review. 

A Mexico-domiciled motor carrier committing certain types of violations identified through roadside inspections, or any other means, may be subjected to an expedited safety audit or compliance review, or may be required to submit a written response demonstrating corrective action. 

The violations that may subject a Mexico-domiciled motor carrier to a safety audit or compliance review or written response include ... 

A satisfactory response to a written demand for corrective action does not excuse a carrier from the requirement that it imdergo a safety audit or compliance review (as appropriate) during the provisional registration period. 

If at the end of this 18-month period, the FMCSA has not been able to conduct a safety audit or comphance review, the carrier will remain in the safety monitoring system until a safety audit or compliance review is conducted. If the results of the safety audit or compliance review are satisfactory, the carrier s provisional operating authority or provisional Certificate of Registration will become permanent. 

Unsatisfactory Rating — If a carrier is assigned an unsatisfactory safety rating following a compliance review or a safety audit determines that a carrier does not exercise the basic safety management controls necessary to ensure safe operations, the Federal Motor Carrier Safety Administration (FMCSA) wOl provide the carrier written notice (as soon as practicable) that the carrier s registration wiU be suspended. 

If the carrier demonstrates that the compliance review or safety audit contained a material error, its registration will not be suspended. 

Conditional Rating — If a carrier is assigned a conditional rating following a compliance review, the carrier is subject to the same provisions as a carrier that receives an unsatisfactory rating, except that its provisional registration will not be suspended. 

Failure to Provide Documents or Evidence — If a carrier fails to provide the necessary documents for a safety audit or compliance review upon reasonable request, or fails to submit evidence of the necessary corrective action as provided by 385.105, the FMCSA will provide the carrier written notice (as soon as practicable) that its registration will be suspended 15 days from the service date of the notice unless it provides all necessary documents and information. 

The carrier is rated satisfactory or conditional after a compliance review or... 

FMCSA will schedule a new entrant for a safety audit as soon as practicable if the new entrant that commits any of the actions listed above and has not had a safety audit or compliance review. 

If the new entrant has had a safety audit or compliance review, FMCSA will send the new entrant a notice advising it to submit evidence of corrective action within 30 days of the service date of the notice. 

Unfit — If a new entrant is determined to be unfit after a compliance review, its new entrant registration will be revoked. 

Lack of Safety Audit or Compliance Review — If a safety audit or compliance review has not been performed by the end of the 18-month period through no fault of the motor carrier, the carrier will be permitted to operate as a new entrant until a safety audit or compliance review is performed and a final determination is made regarding the adequacy of its safety management controls. 

Based on the results of the safety audit or compliance review the FMCSA will either ... 

Note A safety audit will not result in a safety fitness determination. Safety fitness determinations follow completion of a compliance review. 

Converting CR (compliance review) information into a safety rating. 

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