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.