What are Post-Handover Support Services?

Our services provide comprehensive support post-project handover, including customized SOP training, regulatory inspection readiness audits, preventive maintenance plans, and APR/PQR frameworks to ensure GMP-compliant operations.

Why is it Critical?

Post-handover support ensures a smooth transition to operational efficiency, maintains product quality, and aligns facilities with global regulatory standards, minimizing risks during inspections.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services delivers expert-led support, guiding pharmaceutical facilities to establish sustainable, audit-ready operations with a focus on compliance and performance.

Our Expert Support Approach

At Indivirtus Healthcare Services, our Post-Handover Support services are led by seasoned regulatory experts specializing in GMP compliance. We provide hands-on SOP training, conduct thorough inspection readiness audits, and develop preventive maintenance and APR/PQR systems tailored to your facility’s needs.

Our approach emphasizes practical implementation and ongoing guidance, ensuring your team is equipped to maintain regulatory alignment and operational excellence in a sustainable GMP-compliant environment.

Post-Handover Support Deliverables

Customized SOP Training Sessions: Tailored training for operational and compliance procedures.

Regulatory Inspection Readiness Audits: Comprehensive audits to prepare for regulatory inspections.

Preventive Maintenance Calendar: Structured plans for equipment and system upkeep.

APR/PQR Frameworks: Tools for annual and periodic product quality reviews.

Compliance Reference Guides: Supplemental resources for ongoing regulatory adherence.

Regulatory Compliance & Global Standards

Our Post-Handover Support services align with stringent global standards, ensuring your facility is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance quality assurance and regulatory confidence.

  • ICH Q10: Pharmaceutical Quality System framework for robust operations.
  • GMP: Global good manufacturing practice guidelines for quality assurance.
  • US FDA 21 CFR Part 211: U.S. regulations for pharmaceutical manufacturing and quality control.
  • EU GMP Annex 1: European guidelines for sterile manufacturing compliance.
  • WHO TRS 1019: Global standards for GMP-aligned operations.

Applications & Use Cases

Our Post-Handover Support services are essential for pharmaceutical manufacturers transitioning to full operations after project completion. Ideal for ensuring GMP compliance, these solutions support regulatory inspections, equipment maintenance, and product quality reviews. Key use cases include establishing sustainable quality systems, preparing for FDA or EMA audits, and optimizing operations for new or upgraded facilities.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led post-handover support backed by certified regulatory experts with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.

With a commitment to industry best practices, we empower your facility with sustainable, compliant, and efficient operations, driving regulatory success and operational excellence.

Frequently Asked Questions

Frequently Asked Questions

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.