Quality Management

From day one to delivery, our Quality mindset is grounded in your success.

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Quality as a Guiding Principle

Quality is the foundation for everything we do. In AAV manufacturing, patient safety, product consistency and efficacy, rigorous compliance, and scalability are the cornerstones for developing and delivering safe and effective gene therapies. At Forge, our highly trained Quality Unit maintains strict quality oversight to support our cGMP manufacturing efforts and to ensure compliance with all regulatory requirements.

Our Quality Unit Structure

Our Quality Unit is set up to support clients at every phase of manufacturing and represents 30% of Forge’s organization. Each step ensures that we deliver safe and effective drug products as intended for the patients our clients serve.

Comprehensive Quality Assurance

Quality Assurance (QA) at Forge is a collaborative effort aimed at ensuring that products are manufactured in compliance with cGMP standards and Safety, Quality, Identity, Potency, and Purity (SQUIPPs) requirements essential for patient safety. Our dedicated QA teams provide support for your program across several areas including AAV and plasmid manufacturing, document control, and quality oversight of the laboratories.

Not merely an internal regulatory body committed to the compliance of stringent regulations and guidelines set forth by the FDA, EMA, and other regulatory agencies, our QA teams work alongside various departments and hand-in-hand with you to support the production of safe, pure, and effective products.

Stringent Quality Control

To ensure that the highest standards of quality are being met at every stage, Quality Control (QC) at Forge is embedded as a critical aspect of our manufacturing process. Led by a team laser-focused on the testing and verification of every production batch at multiple stages, our meticulous QC approach is unwavering to safeguard the quality and safety of your product.

QC teams systematically perform the analytical testing that is critical to achieving quality and safety standards. This includes continuous monitoring to mitigate risks and multistep facility and equipment controls. A separate team performs environmental monitoring.

Optimizing Manufacturing with Our Quality Systems

Our Quality Systems form the backbone of our commitment to excellence—spanning everything from document control and deviation management to training, audits, corrective and preventive actions, continuous improvements, change controls, and electronic data integrity. At the Hearth, these systems are seamlessly integrated with cutting-edge equipment and automated workflows to ensure compliance, consistency, and confidence at every step of AAV manufacturing and quality control.

Whether it’s in our dedicated QC labs or across our broader manufacturing operations, Forge’s rigorous framework ensures that every therapy is built on data you can trust and systems you can rely on.

Support from Industry Leaders in Quality

Our partnership with Veeva and its trusted systems support our rigorous approach to Quality and our mission to deliver safe, reliable gene therapies. They include Veeva Quality, Veeva Laboratory Information System (LIMS), and Veeva Regulatory Information Management (RIM). At Forge, we put resources behind what matters most and make Quality a daily reality. 

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