GRAM delivers exceptional quality — in our relationships, our processes and our results. Our track record of cGMP compliance and FDA approval reflects our long-term consistency and reliability.
Measure Success Through Your Product’s Life Cycle
Our approach to sterile manufacturing fully supports cGMP compliance. We have established key metrics that focus on quality throughout the product life cycle. GRAM has developed and applied robust quality systems for validation, document management, quality control and batch release. Our quality systems are continuously audited internally, as well as by clients and regulatory agencies.
Simplify Compliant Document Management
GRAM employs a validated, CFR Part 11 compliant electronic system for document management. Our team uses this system for training and documents, including standard operating procedures, protocols, specifications and forms.
Leverage Quality Processes and Equipment
We offer microbial and chemical testing services for raw materials, in-process compounds, finished goods and stability samples. GRAM performs testing in accordance with USP/NF and EP methodologies and monographs, in addition to client-specific methods. Our analytical capabilities include endotoxin testing, bioburden, microbial limits, particulate, pH, TOC, GC, HPLC, Karl Fischer, UV Vis and various wet chemistry tests. We have validated all analytical equipment that uses software to collect and analyze data for full compliance with 21 CFR Part 11.