QUALITY AND PROJECT MANAGEMENT
Passion for your process, product and patients
Therapure Biomanufacturing is a contract development and manufacturing organization (CDMO) with knowledge of the intricacies related to manufacturing processes and the importance of product quality and patient safety. We have a passion for enhancing our clients’ experience and we strive to exceed their expectations throughout each project.
We view quality systems and project management as key components of our drug development and manufacturing services. They are the backbone of every project we undertake.
We provide a full range of quality control services that follow through each stage of your product’s development into commercial manufacturing. Prior to product manufacturing, analytical methods are transferred to Therapure’s Quality Control department where they are qualified (for phase I–II clinical programs) or validated (for phase III–commercial programs).
Our quality control experts provide the following:
- Validation support for equipment, cleaning procedures, processes and vendor qualification
- Incoming raw material, in-process and finished product testing using our modern microbiology and chemistry laboratories
- Custom methods
- Compendial methods (USP, EP, NF)
- ICH-compliant stability protocols
- Temperature- and humidity-controlled storage chambers on 24-hour computer-monitored system
We understand that the quality of your product is critical, and our quality assurance team shares your passion. As a Therapure client, your product is manufactured according to a rigorous Quality Management System (QMS) that includes a 21 CFR part 11 compliant electronic deviation and corrective and preventative action (CAPA) management system. Our quality systems help ensure that Therapure is in compliance with current regulatory standards and industry best practices.
A 21 CFR Part 11 compliant electronic Learning Management System is under implementation. This will further contribute to our QMS. It will increase transparency in training and operational efficiency, and will support employee development.
Therapure assigns each client a dedicated Project Manager who serves as your conduit for communication within the Therapure organization. Our Project Managers have the management skills necessary to coordinate Therapure’s technical expertise and ensure your project is delivered on time, in full, on budget and within the terms of the agreement. Your Project Manager will:
- Foster a collaborative relationship through open and clear communication
- Drive project team excellence
- Work with you to build a detailed project plan from the technical transfer stage to project completion, leveraging the Therapure subject matter experts
- Identify project risks, including developing contingency and mitigation plans
- Drive project execution, engaging the expertise of required internal resources, and capturing actions and decisions over the life cycle of the project
- Manage project scope, including budgets
- Close out the project and review lessons learned to support the continual improvement of Therapure’s processes