Thermo Scientific CGMP Chemicals

Services to Enhance the Delivery of Raw Materials for Regulatory Compliance and Patient Safety

When scaling operations toward your vision of commercialization, it is critical to secure reliable raw materials, optimize capacity, and comply with regulatory requirements.

Thermo Fisher Scientific CGMP chemical supply chain specialists can help you ensure compliance and reduce process interruptions or delays.

Storage | Sourcing Strategy and Procurement | Inventory Management | Sampling | Dip Tube Exchange | Chemical Container Recycling, Reuse, and Disposal | CGMP and GDP-Validated Facilities

Raw material storage space compliant with Current Good Manufacturing Practices (CGMP) and Good Distribution Practices (GDP) helps ensure that products are consistently controlled according to quality standards. Maintaining such standards in storage also helps ensure regulatory compliance, which is crucial for market approval and consumer trust.

The Thermo Fisher team can offer CGMP- and GDP-compliant storage to help maintain the safety, integrity, and potency of biopharmaceutical raw materials, which can be sensitive to environmental conditions, such as temperature, humidity, and light. Their regulated service centers help prevent contamination, degradation, and other quality issues that could compromise patient safety and product efficacy.

• ISO 9001:2015 certified
• Validated CGMP/GDP-compliant Quality Management System (QMS) and technology systems
• HAZMAT-controlled for flammables, corrosives, poisons, and oxidizers
• Temperature mapped, controlled, and monitored*
• ISO Class 8-qualified cleanrooms; CFR 21 Part 11 compliant*

*Available at select locations.

When precision and consistency are paramount, any disruption or variability in materials can lead to significant process delays, increased costs, or even recalls. A well-defined sourcing and procurement strategy enables process continuity.

The Thermo Fisher team can help find the right suppliers and manufacturers, becoming a single point of contact to consolidate and manage your chemical orders. Ensuring a reliable supply of raw materials is essential for the consistent production of safe and effective biopharmaceutical products.

Services include:

• Sourcing support: material documentation, selection, qualification
• Supplier management: audit facilitation, quality agreements
• Alternate sourcing assistance: identifying more than one chemical manufacturer to meet formulation requirements
• Order management: consolidating chemical orders and providing logistics visibility

Equipping your team with their essential raw materials when needed can help save valuable facility space so that you maintain consistent, efficient operations. Optimizing stock levels can also help minimize waste and reduce holding costs.

The Thermo Fisher team can help mitigate stockouts, reduce inventory carrying costs, and improve overall supply chain efficiency, helping you build supply continuity for your most critical CGMP chemicals.

• Inventory level calculations based on 12-month forecasted lead times and process demands
• Management and monitoring of inventory levels by Thermo Fisher CGMP supply chain specialists
• Readily available inventory stored offsite in a Thermo Fisher facility and delivered as needed

Preparing materials can often be resource intensive when trying to ensure they meet stringent quality and safety standards before entering processes. It allows for the early detection of contaminants or inconsistencies, which can prevent costly process errors and ensure the integrity of the final product. Thorough sampling supports regulatory compliance by providing the necessary documentation and traceability required for audits and quality assurance.

Our highly trained team can help your materials accelerate through quality release steps, so they are ready for their application into processes upon delivery. Quality specialists confirm material labels, forms, and product labels match, and conduct sampling^* in CGMP-compliant environments within ISO Class 8-qualified cleanrooms. They also label sample bottles and product containers and prepare quality documentation. Specialists work with you to adapt and meet your QC requirements.

4 sampling types are available:

• Individual (ID)
• Composite
• Tailgate
• 500 L bulk

Nitrogen overlay* can be added as a part of this service.

*Available at select locations.

Exchanging dip tubes helps maintain the purity and integrity of the chemical solutions, as worn or contaminated dip tubes can introduce impurities. Regular replacement helps prevent cross-contamination between different batches of chemicals, ensuring consistent quality and efficacy of the biopharmaceutical products.

Our team can exchange dip tubes to help further prepare solutions for operations. Exchanges are conducted in CGMP-compliant environments within ISO Class 8-qualified soft-wall cleanrooms to exchange dip tubes in liquid chemical drums and totes with reusable, undamaged dip tubes.

Proper recycling, reuse, and disposal of chemical containers are essential for minimizing environmental impact and promoting sustainability. Effective management of these containers ensures that hazardous residues are safely handled, reducing the risk of contamination and harm to both humans and the ecosystem.

The Thermo Fisher team supports your sustainability goals and E&HS with solutions that recycle, reuse, donate, or repurpose unwanted chemical raw materials generated by your processes.

Facilities and environments with CGMP and GDP compliance are crucial for ensuring that CGMP-manufactured chemicals maintain their stringent quality standard, which is essential for the safety and efficacy of the final products when approaching regulatory filings. Thermo Fisher has facilities in North America compliant to CGMP and GDP standards where chemical services are conducted, becoming an extension of your process space and quality requirements to help protect the efficacy of raw materials, from sourcing through delivery.