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GMP MATERIALS MANAGEMENT AS A MANAGED SERVICE

Enabling the next-gen pharma facilities of the future

We embed with your teams to design, qualify, and manage GMP materials that are fit for function, commercially scalable, and audit-ready from day one.

Download GMP Materials Blueprint
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THE LIGHTHOUSE FRAMEWORK

One single operating standard for your entire GMP Materials Program

The Lighthouse framework connects design, qualification, supply chain, and sustainability into one auditable material lifecycle by using a common architecture. This creates a controlled material program where every component is specified, qualified, traceable, and commercially dependable across large molecule GMP facilities and sites.

OUR SOLUTIONS

Four disciplines, one integrated program

Each capability within the Fastnet bio model is designed to function as a standalone engagement or as part of a fully integrated materials lifecycle program.

Design

Materials Selection and Design

Translate process requirements into audit-ready assemblies, without costly redesign cycles.

Get to audit-ready faster.

Design
Qualification

Qualification and Compliance

Build a qualification program that survives regulatory scrutiny and scales with your portfolio.

Build a scalable qual program.

Qualification
supply

Supply Chain and ERP

Convert your GMP materials from a sourcing variable into a controlled, predictable asset.

Gain control of your supply chain.

Supply Chain
sustain

GMP Release and Sustain

Keep GMP release workflows on track and inspection-ready, from first batch to ongoing compliance.

Stay inspection-ready from day one.

Sustainability
20+
Subject Matter Experts
Up to 90%
Reduction in E&L Qualification Timelines
Up to 30%
Reduction in Supply Chain Costs
<14 Months
Tech Transfer to GMP Release
YOUR PROGRAM PRIORITY

Tailored to your operational context

The materials lifecycle program looks different depending on where in the organization you sit. See how the program applies to each specific operational mandate.

GMP materials designs that arrive FAT qualified, documented, and ready to validate.

We work from your P&ID, process parameters, and regulatory constraints to configure complete GMP materials designs, with all documentation structured for FAT/SAT. Standardize your GMP materials architecture early and give every downstream function a single source of truth.

  • Process visualization
  • Assembly standardization
  • Component selection
  • Naming conventions

See Our Design Approach

Qualification frameworks designed for inspection readiness and clean transfer between sites.

We build end-to-end material qualification programs structured as reusable assets from the start. The qualification package for your first molecule becomes the framework for the next one.

  • GMP risk assessments
  • E&L packages aligned to USP <665>, USP <1665> and Annex 1
    Contamination
  • Control Strategies
  • SOPs
See Our Qualification Approach

ERP master data, dual sourcing, and supplier qualification managed as one program.

We combine deep GMP materials knowledge with supply chain execution. Run a cost analysis of your current program and restructure the supply controls that are driving unnecessary spend with targeted improvements across BOM accuracy, vendor qualification, and sourcing strategy.

  • Properly maintained specification
  • ERP master data management
  • Qualified alternates
  • Dual-sourcing strategy
  • Supplier qualification programs built around commercial volumes

See Our Supply Chain Approach

Accelerate tech transfer without rebuilding your material qualification from the ground up.

We build process-agnostic qualification frameworks designed to be portable across molecules and sites from the outset. Close material qualification gaps systematically before the transfer initiates, with a material program built for transfer from the start.

  • Pre-qualified
  • Properly documented
  • Ready for site-specific gap
  • Ready for assessment
See How We Support Tech Transfers

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Fastnet bio Hero Blueprint Cover No Grid
GMP MATERIALS SYSTEM BLUEPRINT

A new standard for GMP materials programs

The GMP Materials System Blueprint defines the architecture of a complete materials program, integrating component specification, E&L qualification, supply chain governance, and sustainability reporting. It is structured as an operational reference designed to give Quality, Engineering, Supply Chain, and MSAT leaders a shared frame of reference for what materials program maturity looks like at commercial scale.

Download the Blueprint
SPEAK TO A FASTNET BIO SME

Get a personalized program strategy

Book a 30-minute scoping call with a Fastnet bio specialist. No sales material, just a direct conversation with someone who has done the work. Our specialists work with Quality, Engineering, MSAT, and Supply Chain teams to map existing material programs against the Lighthouse framework and identify where the highest-impact gaps lie. 

Not ready to talk yet? You can also use our Scope Calculator to estimate SMEs required for your GMP materials program scope and walk into the resourcing conversation with a total SME hour estimate and recommended team size.

Estimate project needs
Discuss your scope with an expert