COMPLIANCE REVIEW

Parsons provides audit, system evaluation, standard operating procedures, and training services associated with compliance review. We have helped our clients find practical solutions for regulatory compliance issues, develop and maintain quality systems, and ensure the validity and accuracy of their data. Parsons participates in two major compliance-monitoring areas, environmental and pharmaceutical.

Compliance reviews include actions to:

• Determine compliance with applicable laws, regulations, permit conditions, orders, and settlement agreements
• Review and evaluate the activities of the regulated community
• Determine if imminent and substantial endangerment may exist
• Identify substantial risks to human health and the environment

Environmental compliance monitoring and review consists of:

• Surveillance and pre-inspection activity to obtain general site information
• Inspections on site of record reviews, observations, sampling, and interviews
• Investigations or record reviews
• Recording reviews derived from routine self-monitoring requirements, inspection reports, citizen or employee tips, or remote sensing
• Targeted information gathering to provide or acquire more accurate information
• Remediation compliance monitoring of work required by regulation

Pharmaceutical compliance monitoring programs consist of:

• Preparing protocols for stability studies following guidances ICH Q1A, Q1B, and Q1C as well as Food and Drug Administration Draft Guidance for Stability of Drug Substances and Drug Products and ICH Q5C
• Developing and validating stability-specific and stability-indicating analytical methods
• Preparing current good manufacturing practice-compliant standard operating protocols for operation of the stability testing laboratory
• Preparing standard operating protocols for upkeep and maintenance of the stability sample storage
• Using statistically sound sampling techniques required for stability studies
• Using statistically sound techniques to estimate drug substance retest and expiration dating
• Evaluating, selecting, installing, and implementing computerized stability information systems compliant with 21 CFR 11, good automated manufacturing practice for computerized tracking, data collection, and information handling systems
• Elucidating mechanistic pathways and kinetics associated with degradation of active pharmaceutical ingredients (API) and drug products
• Preparing and reviewing final stability report required as part of the chemistry, manufacturing and controls portion of the New Drug, Abbreviated New Drug, and Biological Licensing Submissions
• Meeting the client's operating goals and ensuring that those goals are in compliance and valid