Radio pharma GxP Compliance Audits and Consulting

​Regulatory Strategy, Compliance, and Inspection Readiness

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• Activities:

  • Create tailored regulatory roadmaps for product development through commercialization.

  • Prepare submissions for IND (Investigational New Drug) and NDA (New Drug Application) filings.

  • Manage interactions with regulatory bodies, including Type B and C meetings with the FDA.

  • Conduct mock inspections to identify potential non-compliance areas.

• Deliverables:

  • Regulatory submission templates.

  • Gap assessment reports and remediation plans.

  • Inspection readiness checklist and staff training.

GMP Facility Design, Qualification, and Environmental Monitoring

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• Activities:

  • Assist with facility layout design for compliance with ISO 14644 cleanroom classifications.

  • Oversee installation and qualification (IQ/OQ/PQ) of equipment, such as hot cells, isolators, and dose calibrators.

  • Review HVAC, water systems, and radiation shielding to ensure compliance.

  • Audit environmental monitoring programs, focusing on air quality and microbial control.

• Deliverables:

  • Qualification protocols and final reports.

  • Facility blueprint with recommendations for improvement.

  • Environmental monitoring audit reports.

Process Development, Manufacturing Optimization, and Stability Programs

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• Activities:

  • Develop and validate radioisotope labeling processes and aseptic filling techniques.

  • Optimize lyophilization processes to ensure product stability.

  • Implement Lean Six Sigma practices to reduce waste and increase efficiency.

  • Design and oversee stability programs to monitor potency, radioactivity, and sterility.

• Deliverables:

  • Process flow diagrams and validated SOPs.

  • Lean Six Sigma performance metrics.

  • Stability protocols and final study reports.

Quality Management System (QMS) Development and Internal Auditing

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• Activities:

  • Implement a custom QMS aligned with ICH Q10 and ISO 9001 standards.

  • Develop SOPs for document control, deviation handling, and CAPA management.

  • Conduct internal audits to identify compliance gaps and operational risks.

  • Monitor QMS effectiveness through KPIs and dashboard systems.

• Deliverables:

  • SOP templates and QMS manuals.

  • Internal audit reports with corrective action plans.

  • Dashboard tools for KPI monitoring.

CAPA, Deviation Management, and Root Cause Analysis (RCA)

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• Activities:

  • Facilitate root cause analysis (RCA) using tools such as 5 Whys and Fishbone Diagrams.

  • Develop workflows for CAPA tracking and deviation investigations.

  • Conduct CAPA audits to ensure timely resolution and prevent recurrence.

  • Integrate CAPA processes into the QMS for continuous monitoring.

• Deliverables:

  • CAPA investigation reports and effectiveness checklists.

  • Deviation logs with corrective action recommendations.

  • RCA tools and tracking dashboards.

Vendor Qualification, Supply Chain Management, and Cold Chain Compliance

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• Activities:

  • Create a vendor qualification program for raw material suppliers, CMOs, and CDMOs.

  • Conduct on-site and remote audits to assess vendors’ GMP compliance.

  • Implement supply chain risk management strategies to handle disruptions.

  • Review cold chain processes to ensure temperature-sensitive isotopes remain stable.

• Deliverables:

  • Approved vendor list and audit reports.

  • Cold chain audit checklist and risk mitigation strategies.

  • Supply chain performance dashboards.

Clinical Trial Compliance, GCP Auditing, and CTM Oversight

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• Activities:

  • Ensure CTMs are produced, labeled, and stored in accordance with GMP and GCP guidelines.

  • Oversee investigator site inspections and clinical documentation audits.

  • Provide training on blinding and randomization protocols for clinical trials.

  • Develop contingency plans for product recalls or CTM non-compliance.

• Deliverables:

  • Clinical trial quality compliance reports.

  • Investigator site inspection findings and corrective action plans.

  • Mock recall exercise results and recommendations

​Computerized System Validation (CSV) and Data Integrity Auditing

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• Activities:

  • Validate computerized systems (e.g., LIMS, ERP) for 21 CFR Part 11 compliance.

  • Conduct data integrity audits to ensure traceability, security, and completeness.

  • Implement electronic batch record (EBR) systems to streamline manufacturing documentation.

  • Review IT systems for backup protocols and disaster recovery plans.

• Deliverables:

  • CSV protocols and validation reports.

  • Data integrity audit findings with action plans.

  • Compliance roadmap for computerized systems.

Radiation Safety and Risk Management Auditing

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• Activities:

  • Develop radiation safety programs aligned with ALARA principles.

  • Conduct HAZOP studies to identify and mitigate risks in radiation handling.

  • Perform risk assessments for contamination control, equipment failures, and product recalls.

  • Implement risk management plans in accordance with ICH Q9 guidelines.

• Deliverables:

  • Radiation safety protocols and compliance reports.

  • HAZOP study reports with prioritized recommendations.

  • Risk management framework and tracking tools.

Training and Competency Development Programs

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• Activities:

  • Develop and deliver customized GMP, GCP, and radiation safety training programs.

  • Implement Learning Management Systems (LMS) to track employee competencies and certifications.

  • Conduct workshops on CAPA, deviation management, and inspection readiness.

  • Provide certifications for staff handling radioactive materials and high-risk operations.

• Deliverables:

  • Training curriculum and competency matrices.

  • LMS-generated compliance reports.

  • Workshop materials and post-training assessments.

Audit, Inspection, and Post-Inspection Management

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• Activities:

  • Design a comprehensive audit program to ensure compliance with internal and regulatory standards.

  • Provide on-site inspection support, including document retrieval and issue resolution.

  • Develop post-inspection remediation plans to address regulatory observations.

  • Conduct follow-up audits to verify corrective actions and ensure sustained compliance.

• Deliverables:

  • Audit schedules and inspection readiness checklists.

  • Post-inspection action plans and follow-up audit reports.

  • Mock audit results and corrective action recommendations.

Product Recall Management and Complaint Handling

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• Activities:

  • Develop and test product recall plans with defined triggers and communication protocols.

  • Conduct mock recall exercises to assess readiness and identify process gaps.

  • Implement complaint handling systems to track issues and prevent potential recalls.

  • Coordinate with regulatory bodies for timely reporting and resolution of product recalls.

• Deliverables:

  • Recall plan templates and mock recall reports.

  • Complaint trend analysis reports and action plans.

  • Regulatory communication logs for recall reporting.

Continuous Improvement (CI) and Operational Excellence Consulting

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• Activities:

  • Implement Lean and Six Sigma methodologies to identify and eliminate process inefficiencies.

  • Conduct process mapping to streamline workflows and reduce waste.

  • Develop performance dashboards to monitor key metrics and drive continuous improvement.

  • Foster a culture of operational excellence with employee feedback loops and training.

• Deliverables:

  • CI action plans with timelines and KPIs.

  • Process maps and bottleneck analysis reports.

  • Performance dashboards and progress tracking tools.