Office of Compliance

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

AF PA, Written comments from Richard Wasserstrom to Seth Heminway, EPA Office of Compliance, American Forest and Paper Association, Washington, March 7, 2002. 

Office of Compliance Biologies Quality Jerome A. Donlon, M.D., Ph.D., Acting... 

A second PAT team is planned and will include CDER s Office of Biotechnology, Office of Compliance and ORA Team-Bio representatives. Formation of the second PAT Team will provide an additional opportunity to develop close collaboration and cooperation between the PAT team and Team-Bio. Lessons learned from the PAT Team and Team-Bio should also be utilized to identify best practices and to develop recommendations for a broader team approach. 

Comparison of the relevant preapproval batch or batches and proposed commercial production batches CDER chemists are responsible for the comparison of the formulation, manufacturing instructions, and associated in-process and Qnished product tests and specifications established for the relevant preapproval batch or batches with the proposed commercial production batch to determine the acceptability of the firm s proposed scale-up procedure. The Field will compare the process used to make the preapproval batches with the actual process used to manufacture the validation batches. Significant differences in these processes will be evaluated by CDER s Office of Compliance, to determine whether the differences constitute fraud, and by the reviewing officers, to determine whether differences in the processes will affect the safety and effectiveness of the resulting product. 

The guidance specifies the application information that should be provided to the Center for Drug Evaluation and Research (CDER) to ensure continuing product quality and performance chacteristics of the sernisolid topical formulation for specified changes. The guidance does not comment on or otherwise affect compliance/inspection documentation defined by the Office of Compliance in CDER or the Office of Regulatory Affairs at FDA. 

Food and Drug Administration. Guidelines on General Principles of Process Validation. Rockville, MD Division of Manufacturing and Product Quality (HFN-320), Office of Compliance, Center for Drugs and Biologies (May 1987). 

Laboratory Data Integrity Assurance Division, Office of Compliance Monitoring, U.S. Environmental Protection Agency, Washington,... 

Each time an error is made, it is initialed, dated, and one of the code numbers in the list is placed next to the initials and circled. A ccpy of the list is placed in the front of each notebook for reference. Pencil or white out are not to be used under ary circumstances. Note at the bottom of Figure 11 the place for the witness or supervisor to sign. During audits, we have had many discussions about this. The consensus in the Office of Compliance Monitoring is, if there is a place for a signature, sign it. If this practice is not acceptable to the laboratory, an SOP should be developed to explain this deviation in the use of the form. 

This guidance was prepared by the Office of Compliance and the Office of Pharmaceutical Science in CDER at the FDA. 

For further information, contact Jan Welch, GHTF, Study Group 4, Office of Compliance, Center for Devices and radiological Health (HFZ-320), Food [[Page 15760]] and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850,240-276-0115. 

Report of the General Counsel of the Office of Compliance, U.S. Congress. Investigation of the Health Effects of Irradiated Mail, Case Nos. OSH-0201,02, July 2, 2002. 

Office of Compliance and Standards. In this department, data compliance to good laboratory practice (GLP), good clinical practice (GCP) and good post-marketing surveillance practice (GPMSP) is carefully controlled. Applications are checked to determine if they were prepared according to the Criteria for Reliability of Application Data. 

EPA. Guidelines for Water Reuse, EPA/625/ R-92/004 Office of Compliance, US Environmental Protection Agency Washington, Dc, 1992. 

It should be noted that the regulatory authority in each country still has the major say in the requirements within its territorial control even though the US FDA seems to exercise a significant influence on the regulatory requirements of other countries. Finally, it may be instructive to review the top reasons for product recalls based on a report from the FDA Center for Drug Evaluation and Research Office of Compliance ... 

Office of Surveillance and Biometrics Statistical Review for Filing Office of Compliance (OC) Review of Manufacturing Information for GMP Inspection Anytime After PMA filing PMA Filing Decision GMP Inspection(s) by the Field... 

CBER has three offices the Office of Compliance, the Office of Biological Product Review, and the Office of Biologies Research. The Office of Biological Product Review oversees the review of all applications to test investigational products in humans and to market new products, but staff in all three offices actually conduct the reviews. 

A further post-approval role for FDA concerns biennial facility inspections. These are performed by the Team Biologies, often in conjunction with a CMC reviewer from headquarters. Biennial inspections focus on maintenance of cGMPs during continued production post-approval and follow up on post-approval changes. Follow-up to the biennial inspections is coordinated by ORA with assistance from CDER s Office of Compliance (OC). Often, consultation from CDER s product divi-... 

To take the Bureau of Drugs as an example, there is an Office of Scientific Evaluation with divisions formed along pharmacologic lines such as the Division of Neuropharmacological Drugs, the Division of Cardiopulmonary-Renal Drugs, and the Division of Metabolic and Endocrine Drugs an Office of Compliance an Office of Pharmaceutical Re-... 

Contact the Assistant Director for Inspection Oversight, TSA Office of Compliance. 

EPA. 1995. EPA Office of Compliance sector notebook project. Profile of the dry cleaning industry. Office of Compliance, Office of Enforcement and Compliance Assurance, U.S. EPA, Washington, DC. EPA/310-R-95-001. 

US Environmental Protection Agency, Office of Compliance, Sector Notebook Project, Profile of the Metal Mining Industry, Standard Industrial Classification, Washington, DC, 10 Sept 1995. 

US Enviroimiental Agency, Office of Compliance, Sector Note Book Project, Standard Industrial classification 261-265, Profile of Pulp and Paper Industry, Washington DC, Sept 1995. 

US Environmental Protection Agency. (2005). EPA Office of Compliance Sector Notebook Project, Profile of the Rubber and Plastic Industry, 2nd edition. Chapters I, II and III [online]. Available from http //www.epa.gov/compliance/resources/publications/ assistance/sectors/notebooks/mbber.html [Accessed 20 February 2007]. 

Amended TSCA 5 Enforcement Response Policy [hereinafter 5 ERP] as amended and restated (June 8,1989) and further amended in Memorandum from John J. Neylan, Director, Policy and Grants Division, Office of Compliance Monitoring, to Michael J. Walker, Enforcement Counsel, Toxics Litigation Division, (July 1, 1993), available through http // cfpub.epa.gov/compliance/resources/policies/civil/tsca/. 

Memorandum from John J. Neyian, Director, Policy and Grants Division, Office of Compliance Monitoring, EPA, to Michael J. Walker, Enforcement Counsel, Toxics Litigation Division, EPA (July 1,1993). 

EPA Office of Compliance. National Enforcement Trends (NETS) Report, G- lb (May 2009), available tliro lihttp //www.epa.gov/compliance/data/results/nets.html numbers. 

EPA, Office of Compliance Monitoring, Office of Pesticides and Toxic Substances. Enforcement Response Policy for Test Rules Under Section 4 of the Toxic Substances Control Act (May 28,1986). 

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