From Detection to Resolution – Ensuring Lasting Regulatory Compliance
In the life sciences sector, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP) form the foundation of quality, safety, and regulatory trust. Any gaps in these areas can lead to costly delays, product recalls, or enforcement actions.
At BioBoston Consulting, we provide GMP, GDP, and GLP compliance gap closure plans that identify deficiencies, implement corrective measures, and establish systems to sustain compliance long-term. Our structured approach ensures your organization remains fully inspection-ready for FDA, EMA, and global regulatory authorities.
Why Compliance Gap Closure Matters
Compliance is not just about passing an inspection—it is about maintaining product quality, patient safety, and operational integrity. Gaps in GMP, GDP, or GLP processes can result in:
- Regulatory warnings or fines.
- Disrupted supply chains.
- Compromised product quality or trial data integrity.
- Loss of market trust and revenue.
A compliance gap closure plan ensures issues are resolved effectively, preventing recurrence and strengthening your quality systems.
BioBoston Consulting’s Gap Closure Methodology
We do not just identify problems—we guide you through to complete resolution. Our GMP, GDP, and GLP gap closure process includes:
- Comprehensive Gap Assessment – Reviewing facilities, documentation, and operational practices against regulatory standards.
- Root Cause Analysis (RCA) – Determining the true source of compliance gaps.
- Corrective and Preventive Actions (CAPA) – Developing targeted solutions to address and prevent future issues.
- Process Redesign and Optimization – Updating workflows to align with FDA, EMA, and WHO requirements.
- Training and Competency Building – Ensuring staff understand and apply best practices.
- Implementation Support – Helping integrate solutions into daily operations.
- Effectiveness Verification – Confirming that corrective measures achieve intended results.
Areas We Cover in Compliance Gap Closure
Our compliance closure plans address deficiencies across the entire GxP spectrum:
GMP (Good Manufacturing Practices)
- Manufacturing process control.
- Batch documentation and traceability.
- Equipment qualification and calibration.
GDP (Good Distribution Practices)
- Cold chain management.
- Distribution records and traceability.
- Storage conditions and transportation compliance.
GLP (Good Laboratory Practices)
- Laboratory data integrity and documentation.
- Equipment validation and maintenance.
- Method verification and analyst training.
Benefits of Working with BioBoston Consulting
- Regulatory Expertise – In-depth knowledge of U.S., EU, and global GxP regulations.
- Tailored Solutions – Gap closure plans designed for your specific operations.
- Proven Results – Clients achieve compliance readiness with zero major findings.
- Sustainable Compliance – Processes built to prevent future gaps.
The Risk of Delaying Gap Closure
Delaying corrective action increases risk exposure and can magnify compliance issues. Our GMP, GDP, and GLP gap closure plans ensure issues are resolved quickly, minimizing disruption and protecting your reputation.
Continuous Compliance for Long-Term Success
Regulatory standards evolve, and so must your compliance systems. BioBoston Consulting offers ongoing monitoring and improvement programs to keep your operations inspection-ready year-round.
Do not wait for an inspection to expose your vulnerabilities. Take proactive steps with BioBoston Consulting’s GMP, GDP, and GLP compliance gap closure plans and ensure lasting regulatory success.