21st Century Initiatives
Commissioning Agents, Inc. is on the cutting edge of new approaches to quality assurance: a quality systems approach (ICH Q10) that uses quality risk management principles (ICH Q9), grounded on a solid understanding of the process and product based on development studies (ICH Q8) and continuous improvement strategies, which use Process Analytical Technology - PAT (in accordance with FDA guidance on PAT).
We can help you achieve efficient compliance with services such as:
Compliance Approach
Commissioning Agents, Inc. offers its clients practical compliance experience. We identify issues and offer customized solutions that can be integrated into the way in which our client does business. We apply and offer the "owners" perspective. Our compliance consultants have experience with both FDA and EMEA regulations and inspection practices, and have intimate knowledge of the difference between FDA and EMEA requirements and expectations.
Commissioning Agents Compliance Team
Our team's expertise includes aseptic processing, sterilization, lyophilization, analytical laboratory compliance, biotechnology manufacturing and API manufacturing. In addition to compliance services, we offer our clients additional support, including Project Management, Design Review, Commissioning and Validation. This allows us to assist our clients with their project from start to finish in an efficient manner.
Service Description
1. cGMP Compliance Consulting and Auditing services: Completing GMP compliance audits of manufacturing facilities, analytical laboratories, clinical trial material manufacturing facilities, contract manufacturing facilities and distribution centers, and preparing GMP compliance action plans and responses to inspection citations and warning letters.
2. New facilities preparation providing compliance expertise during the design phase, performing design review and helping clients present their design to the FDA.
3. Preparation for regulatory inspections: performing mock-inspections followed by preparation for inspections, and implementing action plans to address the compliance deficiencies and regulatory risk.
4. Quality Assurance services: supporting QA department in all Quality unit responsibilities such as establishing quality systems, policies, procedures, documentation control, deviations, investigations, CAPA, change control and out of specifications results, and reviewingbatch manufacturing and analytical documentation, validation documentation and cleaning validation.
5. Regulatory filing preparation and/or review: preparing QA and cGMP compliance review of regulatory filing, such as applications for new drugs, investigational drugs, comparability protocols, supplements and drug master files.
"Commissioning Agents was key to improving our operations and compliance after we received an FDA Warning Letter. They didn't just tell us what was wrong; they helped us implement practical compliance solutions. Upon re-inspection, the warning letter was lifted and we had no 483 observations."
Our goal is not to "raise" the compliance bar. Our goal is to help you get over it. CAI's industry-experienced compliance consultants help you develop effective and workable compliance strategies, plans, and procedures - solutions that will be used!
