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Regulatory Support for Radiopharmaceutical Operations

At GxP Auditing and Consulting Services, we specialize in helping radiopharmaceutical manufacturers and clinical sponsors meet complex regulatory requirements with confidence. Our GxP radiopharmaceuticals compliance services are tailored to the unique needs of facilities working with radioactive compounds, from early development to commercial production.

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With deep expertise across GMP, GCP, and GLP standards, our consultants bring hands-on experience in quality systems, aseptic processing, radiation safety, and inspection readiness. Whether you're preparing for an FDA audit, optimizing production workflows, or qualifying a new site, we ensure every aspect of your operation meets global compliance expectations.

GxP Radiopharmaceuticals Compliance Services

Why GxP Compliance Is Critical in Radiopharma

Radiopharmaceuticals require highly specialized handling and production environments. These products often combine short-lived radioisotopes with biologically active molecules, demanding precision, sterility, and traceability at every step. Regulatory bodies such as the FDA, EMA, MHRA, and IAEA maintain strict requirements for these operations.

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Our role is to help you meet those requirements while maintaining operational efficiency. From cleanroom qualification to deviation management and data integrity, our GxP radiopharmaceuticals compliance services are built to reduce compliance risk and improve overall product quality.

​Regulatory Strategy, Compliance, and Inspection Readiness

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.

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Deliverables:

  • Regulatory submission templates.

  • Gap assessment reports and remediation plans.

  • Inspection readiness checklist and staff training.

Our Approach to Radiopharma Compliance

We believe compliance should support, not hinder your operations. Our team works closely with your internal stakeholders to understand your processes, identify gaps, and implement sustainable solutions. Every engagement begins with a detailed compliance risk assessment tailored to your radiopharmaceutical product type, scale, and region of operation.

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We use industry-standard tools and methodologies aligned with FDA, EMA, and WHO guidelines, and tailor our approach to your unique challenges, whether you're a clinical-stage company or managing commercial production.

Why Choose GxP Audit Consult?

  • Deep Radiopharma Expertise: Our consultants understand the scientific, technical, and regulatory complexities of working with radiopharmaceuticals.

  • Comprehensive GxP Knowledge: We support compliance across GMP, GCP, GLP, and GDP requirements.

  • Cost-Effective Engagements: Clients trust us to deliver high-impact results without the overhead of large consulting firms.

  • Global Regulatory Experience: We’ve helped clients prepare for audits and inspections by the FDA, EMA, MHRA, PMDA, and more.

GMP Facility Design, Qualification, and Environmental Monitoring

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.

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Deliverables:

  • Qualification protocols and final reports.

  • Facility blueprint with recommendations for improvement.

  • Environmental monitoring audit reports.

Process Development, Manufacturing Optimization, and Stability Programs

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.

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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

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.

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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)

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.

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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

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.

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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

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.

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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

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.

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Deliverables:​

  • Data integrity audit findings with action plans.

  • Compliance roadmap for computerized systems.

  • CSV protocols and validation reports.

Radiation Safety and Risk Management Auditing

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.

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Deliverables:

  • Radiation safety protocols and compliance reports.

  • HAZOP study reports with prioritized recommendations.

  • Risk management framework and tracking tools.

Training and Competency Development Programs

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.

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Deliverables:

  • Training curriculum and competency matrices.

  • LMS-generated compliance reports.

  • Workshop materials and post-training assessments.

Audit, Inspection, and Post-Inspection Management

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.

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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

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.

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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

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.

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Deliverables:

  • CI action plans with timelines and KPIs.

  • Process maps and bottleneck analysis reports.

  • Performance dashboards and progress tracking tools.

Frequently Asked Questions (FAQs)

Ready to Strengthen Your Radiopharma Compliance?

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