How to Conduct a Successful Audit of Your CDMO
Audits are a fact of life in drug development. And, as drug developers increasingly outsource manufacturing, it’s important that the raw materials used in their final products are monitored to ensure that they are safe, effective, free of excessive impurities and sourced from quality suppliers. But while Contract Development & Manufacturing Organizations (CDMOs) are usually responsible for auditing raw material suppliers, it’s the sponsor’s job to audit the CDMO.
While most drug manufacturers properly vet their CDMOs to ensure that they follow current Good Manufacturing Practices (cGMP) across all operations and conduct regular meetings and correspondence to ensure that everyone is on the same page, it’s still important to conduct regular audits to revisit key quality criteria.
Not only are supplier audits a good idea, they’re also driven by international regulatory guidance. For example, in the U.S. CFR 211.84 is used by the FDA to outline recommendations for establishing processes around testing, cleaning equipment and other quality control guidelines.
To carry out these recommendations most effectively, CDMO audits are typically held in person, but these are not typical times. The pandemic has forced companies to delay audits or resort to virtual audits conducted via video call, or leveraging advanced technologies, such as AI or Virtual Reality. While in-person audits are essential in critical industries such as pharmaceuticals, after the pandemic has passed, it’s likely that audits will be conducted less frequently because of the time savings that virtual audits have enabled.
A good rule of thumb for CDMO audits, however, is to conduct one-to-two per year, usually when the sponsor first begins working with a CDMO and then about halfway through a project. Many sponsoring firms leverage experienced consultants to assist with the auditing process. Consultants can play a major role in conducting the audit, as well as communicating and collaborating with the CDMO throughout the project, but it should never replace the involvement of the sponsor, who often understands first-hand the project and communicates most frequently with key stakeholders.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!
In addition to these general guidelines for conducting a sponsor audit, below are eight considerations to think about before conducting a CDMO audit:
- Develop an audit plan. You should leverage guidance from the FDA but also be thoughtful about your audit plan and make sure it provides enough detail and action items to be thorough; the plan should also offer the flexibility to pivot if needed (as we all know too well from COVID-19).
- Review the CDMO’s quality approach. Every CDMO should have an official quality manual or index of Standard Operating Procedures (SOPs). This manual should be shared with you from the beginning of the engagement and reviewed prior to the audit. You should also ask the CDMO if any of its SOPs have changed since you last visited. It’s also important to review regulatory guidance that may have changed since your last visit. This is where a consultant can be quite helpful, since he/she should be proficient in all regulatory affairs.
- Bring along a leave-behind document. It’s useful to provide a brief agenda or presentation to let the CDMO know what you hope to accomplish during the audit. It’s also a good time to share your passion for the project, a pep-talk of sorts that can share key goals and inspire greater collaboration and enthusiasm. CDMOs often feel isolated from the actual impact of the work they do, so this can help everyone see the end-goal and feel like they’re part of the team.
- Tour the plant. Guided by the CDMO’s QA manager, this tour should allow you take the time to review key areas and tasks and ask questions along the way. You can note some of the material lot numbers, ask for identification of equipment and the names of staff members performing key tasks.
- Save the documentation for later. As most of us know, documentation runs rampant in API manufacturing – and is a necessary requirement. You should review all required documentation on the project, but save it for later. An audit is not a good time to review QA reports. It’s important to know that the CDMO is writing effective SOPs that comply with regulatory requirements, but leave it to the CDMO to ensure their own ways of ensuring adherence.
- Review CDMO suppliers. In addition to key areas, such as the production controls, quality system, packaging and labeling, you should also examine the CDMO’s oversight of its suppliers and any subcontractors it uses. Ask if and how it evaluates suppliers to make sure they’re meeting the same high standards as your own.
- Follow the FDA Systems-Based Inspections guidance. You should follow the FDA’s systems-based inspection approach, spending time reviewing the foundational quality systems, such as change control deviations and investigations. Ask to see any Corrective and Preventive Actions (CAPA) or Out of Specifications (OOS) reports, as well as documentation for completed training programs for staff. Also ask to see original qualifications, calibrations and preventative maintenance records.
- Hand out a report card. It’s important in your closing meeting to share your observations and impressions openly and honestly, allowing for ample opportunity for feedback from your CDMO as well. An audit should not only work to uncover any quality issues with your CDMO, but it should also nurture a stronger relationship of mutual trust and respect.
COVID-19 has put a new face on CDMO audits, but their importance will remain today and into the future to ensure that you’re working with the right CDMO for your API manufacturing project. Regardless of the format or rules of conduct, a CDMO audit can go a long way to keeping your project on track, while building long-term relationships along the way.
Author Biography
Jean-Noel David, who holds an MBA from the Goizueta Business School at Emory University in Atlanta and a Master of Science degree from ENSTA Paris, is the managing director for Seqens CDMO North America. He is responsible for growing manufacturing capacity, staff and equipment in North America and integrating U.S. operations throughout Seqens’ 24 manufacturing sites and R&D centers around the world.