Good Manufacturing Practices (GMP) or current Good Manufacturing Practices (cGMP) are regulations established by the U.S. Food & Drug Administration (FDA) that apply to the methods, equipment, facilities and controls required for manufacturing pharmaceuticals and other products.
IRISYS’ experienced formulation development scientists and manufacturing unit work together to optimize the formulation and scale-up for the GMP manufacturing of clinical trial materials and commercial pharmaceutical products. The GMP manufacturing team complies with IRISYS’ rigorous Standard Operating Procedures and FDA Guidelines.
Commercial manufacturing requires a higher level of knowledge, performance, and regulatory scrutiny than production of clinical trial materials. IRISYS has successfully met the requirements for audits conducted by regulatory authorities including recent FDA and California Food & Drug Board inspections.
IRISYS provides the following cGMP manufacturing services:
- Scale up from R&D to cGMP manufacturing
- Technology transfer
- Drug development process
- Formulation optimization
- Clinical trial materials manufacturing
- Pharmaceutical products manufacturing
- Release testing
- Certificates of Analysis
- Formal stability studies according to ICH guidelines
- Commercial product manufacturing