What does post-handover support include?
Post-handover support includes SOP training, audit readiness, maintenance setup, and APR/PQR implementation to ensure your facility operates smoothly and compliantly.
How do you support regulatory inspection readiness?
We conduct mock audits, prepare documentation, and train personnel to ensure your site is fully compliant and confident during inspections.
Can you help with setting up maintenance systems?
Yes, we develop preventive and corrective maintenance plans tailored to your equipment and facility type to reduce downtime and ensure compliance.
What is included in APR/PQR setup?
Our team helps define product review criteria, documentation templates, and reporting systems aligned with GMP to ensure robust annual quality reviews.
Is on-site support available after project handover?
Absolutely. Our experts provide on-site assistance during the initial operational phase to help your team transition seamlessly and address real-time issues.
What do Post-Handover Support services include?
Our services include customized SOP training, regulatory inspection readiness audits, preventive maintenance calendars, APR/PQR frameworks, and compliance reference guides for GMP-aligned operations.
Who benefits from Post-Handover Support services?
Pharmaceutical manufacturers transitioning to full operations after project handover, particularly those seeking GMP compliance and audit readiness, benefit from our tailored support services.
How do these services ensure regulatory compliance?
Our services align with ICH Q10, GMP, US FDA 21 CFR Part 211, EU GMP Annex 1, and WHO TRS 1019, ensuring your facility meets global regulatory standards and is audit-ready.
What deliverables are provided with the service?
Clients receive customized SOP training sessions, regulatory inspection readiness audits, preventive maintenance calendars, APR/PQR frameworks, and compliance reference guides.
Can the support services be customized for our facility’s needs?
Yes, our services are tailored to your facility’s specific operational and regulatory requirements, ensuring practical and compliant solutions for seamless operations.
How do the services support inspection readiness?
We conduct thorough inspection readiness audits and provide tailored SOP training and APR/PQR frameworks to ensure your facility is fully prepared for regulatory inspections.