Production Process Development

It's Time to Fine-Tune Your Processes.

At Amicus, we know that getting the most out of your production process is key to success in the pharmaceutical industry. Our services are designed to help you fine-tune and optimize every part of your commercial manufacturing process to meet the highest standards of quality and compliance.

We have worked with large and small pharma companies, so we can offer solutions to address your specific challenges. Whether you want to streamline your formulation development, CIP/SIP, or material and personnel flow, we have the expertise and commitment to get you there.

Developing Efficient & Compliant Processes for Pharmaceutical Companies

Amicus offers production process development services for quality control to ensure your pharmaceutical products are produced efficiently, safely, and according to GMP. Our solutions are tailored to your needs, whether you are a large or small pharmaceutical company. By working with Amicus, you get the expertise and collaboration to deliver real results.

Formulation Development: We take your current production formulation and design a scalable & efficient drug manufacturing process for a range of unit operations that complies with FDA regulations.

CIP/SIP Process Development: We can develop effective CIP and SIP cycles for your specific product formulations that meet applicable regulatory standards and ensure product quality.

Material, Personnel, & Process Flow Design: We can design systems for establishing and documenting the performance of effective and raw materials, personnel, and process flow to ensure a high level of control.

The Plan for Optimizing Your Pharmaceutical Process

Initial Assessment
Our experts start by conducting an assessment of your current process. We review your formulation, cleaning procedures and flow designs to identify areas to improve.
01
Solution Design
Based on our assessment, we design solutions to meet your specific needs. This includes designing scalable formulation processes, CIP/SIP cycles, and material and personnel flow.
02
Implementation Support
We provide on-site support to implement the new processes, ensuring a seamless transition and minimal downtime.
03
Compliance
Throughout the process, we ensure all changes comply with regulatory requirements and GMP manufacturing guidelines. We stay up to date with industry requirements and best practices in drug manufacturing to keep you compliant.
04
Ongoing Improvement
We continue to monitor your production processes and provide ongoing support to ensure continued efficiency and compliance. We help you adapt to new challenges and optimize further.
05

Frequently Asked Questions

Amicus works with 503b outsourcing facilities, pharmaceutical manufacturers, medical device companies, and other FDA-regulated businesses.

Our expert team stays up to date with the latest FDA guidelines and GMP regulations for pharmaceutical development. We design to these standards and provide ongoing support for continued compliance.

CIP (Cleaning In Place) and SIP (Sterilization In Place) are processes used to clean and sterilize your materials and equipment without disassembly. We design cycles for your product formulations to meet regulatory requirements and product quality.

We assess your specific goals and resources to design solutions that are scalable and cost-effective for both large pharma companies and small businesses with limited budgets.

Yes, we’re dedicated to partnering with you to improve various pharmaceutical processes, including continuous pharmaceutical manufacturing, to improve efficiency, safety, and product consistency.

Get in Touch Today!

Contact Amicus now to see how our expertise can transform your pharmaceutical manufacturing process.

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