GMP / cGMP Manufacturing
IRISYS serves as a contract manufacturing organization (CMO), sometimes called a contract development and manufacturing organization (CDMO), for our clients. We provide cGMP contract manufacturing services, helping small and mid-sized pharmaceutical companies with comprehensive services from drug development through drug manufacturing.
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. As an experienced CMO, IRISYS is well-versed with these regulations.
IRISYS’ knowledgeable 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 GMP manufacturing
- Pharmaceutical products manufacturing
- Release testing
- Certificates of Analysis
- Formal stability studies according to ICH guidelines
- Commercial product manufacturing
Frequently Asked Questions:
What are the current good manufacturing practices?
cGMP stands for Current Good Manufacturing Practice. It refers to FDA regulations that govern manufacturing facilities and their processes to ensure proper design, monitoring, and control. Organizations that practice cGMP contract manufacturing standards, should establish strong quality management systems, obtain quality raw materials, establish strong operating procedures, identify and review product quality deviations, and maintain reliable testing laboratories. This formal system of controls at a contract manufacturing organization helps to prevent unsafe errors such as contamination and mix-ups as well as system deviations that lead to failures and errors. cGMP contract manufactures that practice current good manufacturing practice ensure that safe quality standards are met.
It is important to understand that CGMPs are a minimum set of requirements. At IRISYS we have comprehensive and modern quality systems and processes, as well as risk management approaches that exceed these minimum standards.
Why is GMP so important?
Testing alone is not adequate to ensure quality. In most instances, testing is performed on a small sample of a batch so that a majority of the batch can be used for end users rather than be destroyed by the testing itself.
It’s imperative that drugs are manufactured with practices and conditions required by cGMP regulations to assure that quality is built into the design and manufacturing process at every step of its manufacturing cycle. Facilities that are in great condition, equipment that is properly managed and operating at peak performance, proper training and use of qualified employees, and reliable and duplicable processes, are a few examples of how cGMP contract manufacturing organizations requirements help to ensure the safety and efficacy of drug products.