Quality Systems that Ensure Successful Manufacturing
Our clients have discovered that GRAM is dedicated to exceptional quality in every aspect of our business. GRAM has a solid record of cGMP validation and compliance and FDA approval, which means that our clients can expect long-term consistency and reliability. Our clients benefit from GRAM’s commitment to complete transparency and frequent communication. We offer clients the ability to watch a live video feed of their fill online from any computer.
Our approach to sterile manufacturing fully supports cGMP compliance. We have established key metrics that continuously focus on quality throughout the project lifecycle. GRAM’s Quality team plays an integral role in overseeing development work through commercial manufacturing. Robust quality systems are in place for validation, document management, quality control, and batch release. Our quality systems are continuously audited internally, as well as by clients and regulatory agencies.
GRAM employs an electronic system for document management; this system is validated and CFR Part 11 compliant, and is used for management for training, material specifications, forms, stability protocols, and Standard Operating Procedures.
We offer a microbial and chemical testing services for raw materials, in-process, finished goods and stability samples. All testing is performed in accordance with USP/NF and EP methodologies and monographs, in addition to client-specific methods. Some of our analytical capabilities include endotoxin testing, bioburden, particulate, microbial limits, pH, TOC, GC, HPLC, Karl Fischer, UV Vis, AA, and various wet chemistry tests. All GRAM analytical equipment that uses software to collect and analyze data (e.g. chromatography data system) has been validated and is compliant with 21 CFR Part 11.