What are Facility Upgrade Services?

Our services deliver comprehensive brownfield upgrades, including GMP gap assessments, retrofitting, plant expansion, seamless technology transfers, and downtime management, ensuring regulatory compliance and operational efficiency.

Why is it Critical?

Upgrading legacy facilities ensures product quality, compliance with evolving GMP standards, and scalability, minimizing risks and enabling audit-ready operations for global markets.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services provides expert-led upgrade solutions, modernizing pharmaceutical facilities with minimal disruption while aligning with global regulatory standards.

Our Expert Upgrade Approach

At Indivirtus Healthcare Services, our Facility Upgrade services are led by experienced regulatory and engineering experts specializing in GMP-compliant modernization. We conduct detailed GMP gap assessments, design retrofitting and expansion plans, manage technology transfers, and optimize shutdown schedules to minimize production downtime.

Our tailored approach integrates regulatory insights and operational expertise, delivering scalable and audit-ready solutions that ensure compliance with global standards and enhance facility performance.

Facility Upgrade Deliverables

Comprehensive GMP Gap Analysis Reports: Detailed assessments identifying compliance gaps.

Retrofitting and Expansion Design Plans: Tailored designs for facility modernization.

Tech Transfer Documentation and Coordination: Seamless transfer of processes and technologies.

Downtime Management and Execution Schedule: Optimized plans to minimize operational disruptions.

Final Validation Readiness Review: Comprehensive review ensuring audit readiness.

Regulatory Compliance & Global Standards

Our Facility Upgrade services align with stringent global standards, ensuring your modernized facility is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence and operational reliability.

  • GMP (WHO, USFDA, EMA): Global good manufacturing practice guidelines for facility upgrades.
  • Schedule M (2024): India’s updated GMP requirements for pharmaceutical manufacturing.
  • ISPE Baseline® Guides: Industry best practices for facility design and modernization.
  • ICH Q10: Pharmaceutical Quality System framework for robust compliance.
  • EU GMP Annex 1: European guidelines for sterile manufacturing upgrades.

Applications & Use Cases

Our Facility Upgrade services are essential for pharmaceutical manufacturers modernizing legacy plants or expanding operations to meet GMP standards. Ideal for retrofitting, technology transfers, and compliance upgrades, our solutions support regulatory audits and operational scalability. Key use cases include upgrading legacy manufacturing facilities, implementing new technologies, and ensuring compliance for global market expansions.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led facility upgrade solutions backed by certified regulatory and engineering 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 compliant, efficient, and scalable upgrades, driving regulatory success and operational excellence.

Frequently Asked Questions

Frequently Asked Questions

What does a GMP gap assessment include?

A GMP gap assessment includes a detailed audit of facility design, equipment, documentation, and processes to identify deviations from current GMP standards and regulatory expectations.

Can Indivirtus manage both retrofitting and expansion?

Yes, Indivirtus provides architectural and engineering support to retrofit existing facilities and plan expansion projects that comply with GMP and operational efficiency goals.

How is tech transfer handled during brownfield upgrades?

We manage the tech transfer lifecycle including facility readiness, equipment qualification, documentation preparation, and training for seamless process integration.

How do you minimize downtime during upgrades?

We develop a phased execution plan that segments construction and validation into manageable phases, ensuring critical operations are not interrupted wherever possible.

Are brownfield upgrades suitable for regulatory audits?

Yes. All upgrades are planned and executed with regulatory compliance in mind, ensuring readiness for inspections by USFDA, EMA, WHO, and other authorities.

What do Facility Upgrade services include?

Our services include GMP gap assessments, retrofitting and expansion design, technology transfer coordination, downtime management, and final validation readiness reviews for compliant facility upgrades.

Who benefits from Facility Upgrade services?

Pharmaceutical manufacturers modernizing legacy facilities or expanding operations to meet GMP standards benefit from our tailored upgrade solutions.

How do these services ensure regulatory compliance?

Our services align with GMP (WHO, USFDA, EMA), Schedule M (2024), ISPE Baseline® Guides, ICH Q10, and EU GMP Annex 1, ensuring compliance with global regulatory standards.

What deliverables are provided with the service?

Clients receive GMP gap analysis reports, retrofitting and expansion design plans, tech transfer documentation, downtime management schedules, and validation readiness reviews.

Can the upgrade services be customized for our facility’s needs?

Yes, our services are tailored to your facility’s specific operational, regulatory, and scalability requirements, ensuring practical and compliant upgrade solutions.

How do the services minimize operational disruptions?

We optimize shutdown timelines and provide detailed execution schedules to ensure minimal production downtime during retrofitting and technology transfers.