Meet FDA Standards With Expert Validation Services
At Amicus, we know manufacturing a quality product that meets FDA standards is non-negotiable for your business. Good Manufacturing Practice (GMP) starts with manufacturing equipment and production process validation, which proves every aspect of your process is properly designed and works consistently.
Without validation, variability in your process can lead to inconsistent product quality, production errors, and patient safety risks that strain your quality systems and your bottom line. Amicus designs and validates processes and equipment so your manufacturing outputs are safe, reliable, and of the highest quality. Process qualification and validation will help your production remain cost-effective and patient-safe.
Achieve Regulatory Compliance With Our Validation Processes
In the process qualification stage, Amicus develops validation protocols and monitors critical areas for quality assurance so you meet FDA standards. If you need process validation or facility and equipment qualification, contact Amicus. Our validation team will help you manage your projects and develop well-designed processes through every aspect of quality control, process design, and employee training.
Facility Protocols & Qualifications: We monitor your facility's protocols and qualifications to guarantee that you meet all regulatory requirements and that everything runs smoothly.
Aseptic Process Validation (Media Fill Simulation): Our team uses a media fill simulation to perform test procedures to prove the sterility and safety of your aseptic production process.
Process Performance Qualification: We assess your overall manufacturing process to show that your current production processes are consistent and that you produce high-quality products.
Automated Equipment Protocols: We'll help you develop an equipment validation process to easily validate your automated systems.
Continued Process Verification: Maintain consistent product quality and compliance in your manufacturing process.
Stages of Process Validation & Operational Qualification
Our validation process begins with a thorough assessment of your current manufacturing processes and equipment. We work with you to design a comprehensive validation plan specific to your business and regulations. Here’s how it works:
Assessment and Planning
Protocol Development
Implementation
Monitoring and Verification
Documentation and Reporting
Frequently Asked Questions
Process validation is establishing documented evidence that a manufacturing process produces a consistent product meeting its pre-determined specifications and quality attributes.
Validation means that all aspects of your manufacturing process meet regulatory standards. It reduces the chances of product variability, patient safety risks, and costly production errors.
Amicus develops and implements protocols for the validation of your equipment, ensuring it operates reliably and meets all necessary regulatory requirements.
Amicus provides validation services for pharmaceutical manufacturing companies, 503b outsourcing facilities, cannabis product manufacturers, medical device manufacturers, and other FDA-regulated industries.
Process validation should be an ongoing effort, with initial validation followed by continued process verification to maintain ongoing compliance and product quality.
Validate Your Processes & Equipment Today!
Partner with Amicus to design and validate your processes and equipment, guaranteeing consistent, high-quality manufacturing outcomes. Contact us today to learn more about our validation services and how we can help you meet FDA standards.
