5 Best Practices for Maximizing the Benefits of a Supplier Audit

3. Recognize Your Own Technical Capabilities & Limits

Some auditors have prior experience in manufacturing or laboratory settings, while others may have come from a quality assurance background and have little if any technical knowledge of things like GMP equipment, production operations, GMP utilities, and analytical testing. Recognize your weaknesses and fortify them with the help of a professional auditing consultant who has the direct experience necessary to fill in the knowledge gap.

The GMP utilities used by the CDMO and their compliance with regulations are often overlooked or disregarded entirely during audits. Auditor ignorance of HVAC, clean or pure steam, purified water and WFI systems, autoclaves, clean compressed air, nitrogen, and other gases used in equipment operation or in processing activities in manufacturing is a common cause of this problem. These areas also tend to be less well understood by the CDMO’s staff which may lead to noncompliance.

While some GMP utilities can be integrated into the building management system, others might operate independently. In any scenario, the CDMO must receive alarm notifications (such as out-of-specification or out-of-range circumstances), have designated staff members to acknowledge each alarm and record the steps taken to fix the problem. Insist on seeing proof that each utility alarm has been electronically acknowledged, investigated, root cause identified, problem resolved, and most importantly fully documented.  

Gases like clean compressed air and nitrogen, as well as purified and WFI water systems, need to be sampled and tested at regular intervals at each point of usage. Check to see if samples were taken and tested per the frequency dictated by the supplier’s procedures. Sadly, these schedules are rarely met. In order to maintain focus during the audit and identify areas for improvement, you need to have a thorough grasp of the supplier’s GMP utility management process.

4. Identifying the Good & Bad: This is not a Debate Competition

The strengths and weaknesses of a supplier are one of the main takeaways from a thorough audit, along with a comprehensive assessment of the supplier’s level of compliance that may inform your company’s purchasing and other strategic choices. If the auditor’s intention is to impress the supplier with his or her knowledge, then engaging in a debate over the auditor’s interpretation of the regulations is of no use. Experienced GMP auditors tend to avoid this kind of competitive back-and-forth since it doesn’t accomplish much. Spend as much time as is needed finding compliance problems, professionally communicating them to the audit host, and making notes that will be useful for producing the audit report. The upper echelons of your firm should be aware of both the supplier’s strengths and weaknesses. The biggest benefit comes from including all of this information.

5. Conduct interviews with the CMO’s Staff, Operators & Personnel

Quality systems at CDMOs are often drafted by managers and directors with extensive expertise in the field. The knowledge of the employees who implement these processes is crucial to guarantee that your company’s product will be manufactured, tested, stored, and executed properly at all times. Speak with the production operators who will be making your product.   Inquire as to how they would conduct line clearances, load powders into a blender, run a spray dryer, make use of a conical mill, set up a tablet press, visually examine tablets, use metal detectors, and so on. Determine whether they have a firm grasp of their duties by comparing their responses to the CDMO’s SOPs. Keep an ear out for statements like “I normally do…” or “I normally set up the equipment like this…” These expressions indicate poor training, lack of supervision, and a disregard for standard operating procedures.

Takeaways & Conclusion

The supplier audit establishes the framework for future collaboration with the supplier, and the ensuing report should answer the following questions: Will the supplier work to resolve the problems I’ve identified?  Do I have faith that the CDMO will alert and involve appropriate employees at my company without delay if problems arise during production or testing? Does the quality of the supplier’s systems and documentation satisfy my company’s needs and regulatory requirements?  Is the vendor interested in being merely a resource, or do they want to be a collaborator in the product’s success? Finding peace of mind in the answers can help you decide whether to go with the supplier or explore alternatives.