Gibco Cell Culture Quality and Compliance

Key highlights:

• Unified global quality framework aligning processes, documentation, and raw material standards.
• Certified facilities operating to international medical device and GMP requirements.
• Proactive quality planning that embeds risk management and continuous improvement.

All facilities undergo routine internal and third-party audits to verify compliance with international standards and reinforce consistent quality across regions. These shared standards enable every Gibco product to be manufactured with precision and confidence. The table below highlights each facility’s focus, certifications, and CTS qualifications.

All Gibco products are manufactured under current Good Manufacturing Practices (cGMP) within a globally harmonized Quality Management System (QMS) that helps to ensure safety, consistency, and complete traceability. Every manufactured lot is governed by document-controlled batch records that capture each production step in real time and are independently verified for accuracy. We also maintain rigorous complaint tracking and resolution processes to help ensure that every concern is reviewed, investigated, and used to continually strengthen our systems. To support regulatory compliance, customers can request Drug Master Files (DMFs) and CTS Regulatory Support Files (RSFs), enabling documentation needed for audits and submissions.

Together, these practices form the foundation of the Gibco QMS—a connected framework designed to uphold product integrity and earn customer confidence through quality, transparency, and reliability. Our Quality Management System connects every step of production with that same focus on trust and consistency.

The following core quality programs illustrate how we maintain alignment, transparency, and performance across all Gibco product manufacturing sites. Click each to learn more.

Submit a request for a Thermo Fisher Scientific CTS Regulatory Support File or DMF LOA, at thermofisher.com/regulatory.

Our global manufacturing network operates under a unified Quality Management System that maintains the same exacting standards at every site. Through verified processes, aligned equipment design, and harmonized specifications, Gibco products produced at different locations—including Inchinnan (Scotland) and Grand Island (U.S.)—deliver equivalent quality and performance. Manufacturing Facility Equivalency Documentation is available for liquid media, Animal Origin Free (AOF) dry powder media (DPM), and Advanced Granulation Technology (AGT) platforms, confirming consistent manufacturing controls and full inter-site comparability. Customers can rely on Gibco products for uniform product quality, documentation integrity, and dependable supply—anywhere in the world.

We offer two agreement options to support transparency and documentation oversight customers expect from a trusted supplier. Change Notification Agreements deliver timely communication for product or process updates that may affect qualification or documentation. Customers can enroll in this program independently so they receive advance notice of any approved changes. Quality Agreements establish a broader, formal framework that defines quality responsibilities and expectations across multiple sites, helping streamline onboarding and supplier management. Both options are designed to simplify qualification, maintain alignment across our global network, and minimize disruption to your operations.

For agreement requests or additional information, collaborate with our Quality specialists at bpg-multisiteqagrequest@thermofisher.com.

Every Gibco product begins with carefully qualified raw materials evaluated through a harmonized global supplier quality and risk assessment program. This process includes oversight of supplier consistency, traceability, and compliance, helping to ensure confidence in every material used. Our quality controls and testing practices align with globally recognized standards to maintain transparency and reliability across all sites.

Manufacturing takes place in controlled environments that support aseptic processing, including the use of classified cleanrooms and verified sterile filtration steps. These controls protect product integrity and facilitate reproducible performance across formulations.  Raw materials and finished products undergo physical, chemical, microbiological, and functional testing to confirm identity, purity, and performance before release. Each step is designed to maintain full material traceability—from qualified suppliers through to finished product release—for confidence in every lot delivered. This comprehensive testing approach helps ensure every lot meets Gibco product quality standards for safety, consistency, and reliability.

For customers seeking enhanced data transparency, Gibco VeriCert Exchange Services are available to facilitate secure, electronic access to quality control data for custom media and raw materials using industry-accepted ASTM International standards for electronic data exchange—supporting data trending and streamlined qualification.

Our commitment to supplier assurance, controlled processing, and rigorous release testing safeguards every Gibco product formulation—delivering the consistency and reliability expected from a trusted global partner.

Gibco products are labeled according to their intended use to meet regulatory and quality requirements. These designations describe how each product type is manufactured and controlled, offering transparency so researchers can make informed qualification decisions based on their own applications and regulatory needs.

All Gibco products—regardless of label—are manufactured in facilities operating under ISO-certified Quality Management System (QMS) standards, offer the same commitment to quality, consistency, and traceability across the portfolio.

While customers may choose to qualify products outside the stated label claim, these definitions clarify the manufacturing approach, quality controls, and documentation available for each category:

• Research Use Only (RUO): A finished product formulation intended for nonclinical laboratory research. RUO products are not intended for diagnostic procedures or therapeutic use.
• Research or Further Manufacturing (RMF): A finished product formulation intended for use in further manufacturing processes, including those supporting clinical development or commercialization. RMF products are not for direct administration into humans or animals.
• Cell Therapy Systems (CTS): A finished product formulation designed to meet regulatory expectations for use in the production of cell, gene, and tissue-based therapies. CTS products include enhanced quality documentation to support qualification and regulatory submissions.

These definitions offer clarity on how Gibco products are categorized and documented, supporting researchers in selecting and qualifying the right materials for their specific research, manufacturing, or regulatory needs.

Our Gibco Quality and Compliance Support teams bring together scientific, regulatory, and quality experience to assist customers across all stages of their cell culture workflow. Each group works within Thermo Fisher Scientific’s global Quality Management System (QMS) to help provide accurate documentation, audit coordination, and technical guidance.