In an industry as tightly regulated as pharmaceuticals and biotech, inspections by Health Authorities are inevitable, intense, and immensely crucial. At GMP BRIDGE, we’ve steered clients across the globe through the rigorous process of GMP inspections, armed with firsthand experience with agencies like the FDA, ANVISA, MHRA, and European Health Authorities. Theoretically, your manufacturing sites should always be primed for spontaneous inspections. However, we understand the comfort of extra preparedness.
Here's how we fortify your readiness:
- Documentation Review & Preparation: Ensuring your records are impeccable, updated, and inspection-ready.
- Significant Deviation Investigations: A thorough review of your major deviations, ensuring that investigations and resolutions meet regulatory standards.
- GAP Assessments: Proactive identification and bridging of any gaps that could become potential inspection challenges.
- SME Trainings: Equipping your Subject Matter Experts with the knowledge and confidence to articulate processes, results, and decisions effectively.
- Inspection Process Optimization: Enhancing your document flow and inspection preparation processes for seamless execution.
- Mock Audits: Real-world rehearsal for your team, covering every conceivable scenario, ensuring nothing catches you off-guard.
- Regulatory Intelligence Gathering: Keeping you informed on evolving regulatory trends, expectations, and recent industry findings, so you're always one step ahead.
- Inspection Metrics and Analytics: Drawing from past inspections to spot patterns, enabling predictions of potential focus areas in upcoming evaluations.
- Communication Skills Workshops: Fine-tuning the soft skills of your team, ensuring they interact with inspectors with clarity, confidence, and diplomacy.
- CAPA Effectiveness Checks: Verifying that the Corrective and Preventive Actions initiated from previous inspections or internal audits are effectively implemented and sustainable.
- Site Tour Rehearsals: Strategically guiding inspectors through your facilities, highlighting areas of compliance, and setting the narrative pace.