Manufacturing & Supply Chain
Plan, implement, and commission CAPEX projects safely and in compliance with GMP.
We support pharmaceutical, biotech, and medtech companies with the strategic planning and implementation of capital expenditures (CAPEX)—from needs analysis and the bidding process through to GMP-compliant commissioning.
What CAPEX challenges arise in the life sciences sector?
Investments in production facilities are particularly complex in the life sciences sector:
- GMP requirements must be incorporated into the plant design from the outset (Design for GMP/Compliance)
- Requirements documentation (URS, Functional Specification) is incomplete – risk during acceptance testing and validation
- Projects go over budget and miss deadlines due to poor project management and unclear supplier responsibilities
- The qualification and validation of the new facility are being scheduled too late, delaying commissioning
Have GMP requirements already been taken into account in the early planning phase of your next plant investment?
Our CAPEX consulting services.
We support CAPEX projects from the initial needs assessment through to successful regulatory commissioning.
Needs Assessment & Investment Strategy
Analysis of investment needs: make-or-buy decisions, capacity planning, site evaluation, and business case development. Structured decision-making document for management and investors.
URS & GMP Requirements Management
Development of comprehensive User Requirement Specifications (URS) for capital investments. Integration of all GMP requirements (GMP compliance, Annex 1, CSV, hygienic design) from the outset.
Request for Proposals & Supplier Selection
Preparation of technical bidding documents (RFQ, RFP). Technical evaluation of supplier bids. Support for award decisions and contract negotiations.
Project Management & GMP Compliance Audit
Ongoing project management: milestones, budget, scope. Regular GMP compliance assessments during the construction phase. Support for Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
Frequently Asked Questions About CAPEX Consulting.
What is an URS, and why is it important for CAPEX?
The User Requirement Specification (URS) defines all the requirements that a system must meet—technical, functional, and regulatory. A comprehensive URS serves as the basis for the request for proposals, supplier evaluation, and subsequent qualification. Gaps in the URS frequently lead to renegotiations and qualification issues.
What does "Design for GMP" mean?
Design for GMP means that GMP requirements are taken into account right from the initial planning and design stages of the facility: cleanability and disinfectability, hygiene zones, material flow without the risk of cross-contamination, accessible inspection points, and the ability to document all processes.
What is a Factory Acceptance Test (FAT)?
A FAT is an acceptance test conducted at the supplier's site prior to delivery of the system. It verifies whether the system meets the requirements of the URS and, where applicable, the functional specification. FAT reports serve as an important preliminary step for the subsequent IQ/OQ qualification at the final installation site.
How are CAPEX projects related to regulatory changes?
Significant investments in new production facilities or sites may require changes to regulatory approvals (variations)—for example, if the manufacturer or manufacturing site needs to be updated in the approval. ENTOURAGE integrates regulatory impact assessments into investment planning.
Related topics.
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