GMP Facility Design & Automation

Optimize Your Facility With Expert Design & Automation Solutions

As a trusted and experienced consulting partner, Amicus specializes in pharmaceutical facility design and automation services that meet the highest quality and regulatory standards. Our expertise in Current Good Manufacturing Practices (cGMP) and GMP facility design means we can deliver solutions that prioritize efficient manufacturing processes and business profit.

Our expert consultants help pharmaceutical companies of various sizes with FDA compliance and process optimization. We will work with your engineering design firm or cleanroom manufacturer to develop facility specifications that meet your current needs and future plans. We also help with selecting and sourcing automated fill-finish equipment so your facility has the right technology to achieve your goals.

A pharmaceutical worker in full CPE picks over vials laid out on a stainless steel table. She is part of the GMP facility design team at Amicus.

Meet GMP Facility Requirements

At Amicus, our consultants use their in-depth knowledge of manufacturing processes and FDA regulations to design GMP facilities and deliver automation services. We see facilities that are not set up for the processes they are running, often due to remodeled old facilities or poor initial planning. That misalignment causes inefficiencies and compliance issues.

We examine your intended processes, develop facility specifications, and create designs that optimize process, material, and personnel flows. We help you achieve CGP and GMP compliance and simplify your manufacturing process so your facilities run safely and smoothly.

Cleanroom Design: We work with your engineering firm or cleanroom manufacturer to deliver client-specific solutions within your budget and according to your production needs, future plans, manufacturing work, and FDA expectations.

Fill-Finish Automated Equipment: Our team will select and source the best fill-finish automated equipment to meet your capacity and goals.

Quality Assurance and Control: The designs and equipment we choose have all undergone quality control tests and are approved for product safety and efficacy.

How Our Design & Automation Process Works

Consultation
We start by understanding your business goals, production process, and regulatory requirements. This allows us to conduct our assessment with a clear idea of your goals.
01
Facility Audit
Our experts conduct a full facility and operational assessment. We identify areas for improvement and develop the specifications for a compliant and efficient facility.
02
Working with Engineering Design Firms
We work with your chosen engineering design firm or cleanroom manufacturer to develop the detailed design for your GMP facility.
03
Equipment Selection and Sourcing
We assist in selecting and sourcing automated fill-finish equipment for your facility. We consider your capacity, budget, and future plans so you have the right technology at your disposal.
04
Implementation and Support
We support you throughout the implementation phase to ensure a seamless integration of all the equipment and new design. Our team is always available to help with any issues and optimize your operation.
05

Frequently Asked Questions

GMP regulations ensure products are produced and controlled to quality standards. They aim to eliminate risks of contamination in pharmaceutical production that cannot be removed by testing the final product.

Amicus offers facility design and automation services that meet GMP requirements. We work with your team to develop specs, select equipment, and implement processes to be compliant.

We offer our services to pharmaceutical manufacturing companies, 503b outsourcing facilities, cannabis product manufacturers, medical device manufacturers, and any other FDA-regulated industries.

We use our industry knowledge and connections to select and source high-quality, reliable fill-finish equipment that meets your capacity and regulatory requirements.

Yes, we can work with big and small budgets to deliver client-specific solutions that are effective and manageable.

Partner With Amicus for Efficiency & Compliance!

At Amicus, we will help you meet the highest quality and regulatory standards. Contact us today to book your consultation and see how our pharmaceutical facility design and automation services can improve your operation.

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