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 in order to be integrated into the way in which the clients do business, as well as years of industry experience. We apply and offer the “owners” perspective. Our compliance consultants have experience with both the FDA and the EMEA regulations and inspection practices. They have intimate knowledge of the difference between FDA and EMEA requirements and expectations.
Commissioning Agents Compliance Team
Their expertise includes aseptic processing, sterilization, lyophilization, analytical laboratory compliance, biotechnology manufacturing and API manufacturing. In addition to compliance services we offer our clients services which include Project Management, Design Review, Commissioning and Validation. This allows us to help our clients see a project from start to finish in an efficient manner.
Service Description
1. cGMP Compliance Consulting and Auditing services to include the following:
- GMP compliance audits of:
- manufacturing facilities
- analytical laboratories
- clinical trial material manufacturing facilities
- contract manufacturing facilities
- distribution centers
- GMP compliance action plans
- Response to inspection citations and warning letters
2. New facilities preparation: provide compliance expertise during the design phase, perform design review and help present design to the FDA.
3. Preparation for regulatory inspections: perform mock-inspections followed by preparation for inspections and by implementation of action plans to address the compliance deficiencies and regulatory risk.
4. Quality Assurance services: support QA department in all Quality unit responsibilities such as establishing quality systems, policies, procedures, documentation control, deviations, investigations, CAPA, change control, out of specifications results, review of batch manufacturing and analytical documentation, validation documentation, cleaning validation.
5. Regulatory filing preparation and/or review: preparation, QA and cGMP compliance review of regulatory filing such as applications for new drugs, investigational drugs, comparability protocols, supplements, 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!
