Shared Qualification Audits Are Best Practice For Phase 1 Drugs
March 24th, 2022 // 2:11 pm @ jmpickett
At the end of 2021, FDA released an update to its Resiliency Roadmap for FDA Inspectional Oversight. This shared FDA’s success in dealing with COVID-19 on inspections both in the US and overseas and how it is using remote interactive audits and evaluations to support its work.
During the COVID era, FDA has shown it is more focused than ever on a risk-based approach to FDA audits. It needs to be embraced by the drug industry when it comes to vendor and supplier audits, especially in phase 1 investigational drugs.
Qualification Audits In Phase 1
No, qualification audits aren’t required in the cGMP guidance for Phase 1 investigational drugs. But they are usually considered to be a best practice in the pharmaceutical industry. Qualification audits at the start of investigational drug activities are usually carried out before Phase 1 clinical trials.
Sponsors usually perform the qualification audit of CDMOs and CROs they plan to partner with. However, qualification audits for companies in the early stages are done after selection and negotiating contracts. They are then used to validate the choices made and review the compliance of the quality system the vendor has.
The audits also are important to begin the working relationship with the vendor and to review requirements of the project that will be done according to the systems, controls and processes the vendor has.
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It’s a good idea for these compliance audits to be done by quality assurance consultants from the sponsors. They are in charge of overseeing quality and compliance for the vendor. If the auditor knows the lay of the land of the vendor facility and also procedures and staff, it improves the business relationship.
Why Should You Audit?
Sponsors want to work with CDMOs that work in early-stage development and manufacturing for delivering cGMP drug ingredients, drug products and intermediates as quickly as possible. CDMOs have flexibility, knowledge of the industry, and speed necessary for early drug development. They also can pair it with the appropriate quality system that can handle the deviations, changes, and optimization needed if a non-validated process is implemented in both the laboratory and plant.
Note that CDMOs that focus on early drug development and don’t make commercial products do not have to register with FDA. So, they are not required to undergo FDA regulatory audits regularly.
When there isn’t sufficient regulatory oversight, there is more risk. So, it’s important that the sponsor check CDMO compliance to make sure it has robust procedures and systems in place so it can deliver its services well. So, qualification audits are an essential aspect of vendor oversight.
Why Shared Qualification Audits Are Critical
Auditors may be asked by many sponsors to do qualification audits of one CDMO. Note that qualification audits are different than prequalification audits. In the latter, the focus is to check whether product-specific requirements are being adhered to. On the other hand, qualification audits tend to be generic in nature and can be shared by more than one sponsor.
A shared qualification audit is a way that sponsors can save on costs; they can split what the audit costs. For CDMOs, the advantage is reducing the costs of having being host to several audits.
Depending how large the CDMO is, resources needed to handle a sponsor audit may not always be available, and this can make it more difficult to have proper QA staff and other professionals available to address operational aspects.
When sharing audits, CDMOs, auditors, and sponsors are all positioned to benefit from the adoption of shared qualification audits.
When you have determined a qualification audit is necessary, the auditing professional can decide if it’s possible to share it among several sponsors. Key issues to consider are the services the audit will cover, the standards that are the focus of the audit, and the timeframe of the audit.
If it is decided a shared audit is possible, it’s often best to talk to the sponsors separately and discuss how a shared audit may be beneficial. Then talk to the audit host and talk about logistical aspects. It’s key to make sure the audit host can handle a shared audit and there is an agreement regarding audit reports, findings, and confidentiality.
