A Brief Overview of Vendor Qualification and Quality Management

Drug manufacturers are increasingly turning to third-party vendors to help them keep up with their production goals. The FDA allows drug manufacturers to outsource production, but there are strict guidelines that these manufacturers must follow when vetting potential vendors.

The FDA knowingly admits to scrutinizing third-party vendors more heavily. That’s why it’s essential for businesses in the pharmaceutical, biotech, and medical device industries to verify their vendors using the current guidelines.

Companies looking to outsource production should familiarize themselves with these guidelines through additional pharmaceutical training and certifications.

1. Your Company Is Still Responsible for Compliance

Your company is still responsible for maintaining regulatory compliance even if your vendor is handling the majority of the manufacturing process.

These rules are established in 21 CFR Part 820 for medical device companies and FDA Q10 Pharmaceutical Quality System for those in the pharmaceutical industry.

The burden rests with the company that receives the product or service. Your company must monitor and maintain compliance regardless of who manufactured the products. This even extends to consultants that your company works with.

2. Document Your Expectations When Outsourcing

The FDA requires that you create an effective qualification process that you can use to maintain quality control.

We recommend that your business implement a system that is repeatable and scalable as you work with future vendors. Your list of requirements should include things such as:

• What quality control standards and certifications you require
• What manufacturing and production capabilities are needed
• Any necessary compliance requirements
• Whether you require specific technological capabilities
• Expected delivery dates and cycles
• What customer service standards you expect
• Overall product lifecycle management

3. Evaluate All Candidates and Audit Your Final Choices

By creating a structured framework of expectations, you can better assess which vendors are viable options for your business.

Document everything about your potential candidates and evaluate the ones that you feel are the best fit. 

The final step is to audit the candidate that you feel is a good match for your business. A successful candidate must maintain total compliance if you want to avoid potential fines and other penalties.

4. Monitor Your Suppliers and Requalify Them

Your commitment to quality extends long beyond the initial audit and quality agreements that you have your vendors sign.

Improve Your Vendor Qualification and Auditing Processes

Are you looking to improve your vendor qualification and auditing processes? The Center for Professional Innovation and Education (CfPIE) works with businesses in the pharmaceutical, biotech, medical device, and skin and cosmetics industries.

We can help your business implement a vendor qualification and auditing process that is FDA-compliant and designed to improve your ability to ensure quality control with third-party vendors. 

Please call 1-610-648-7550 if you have any questions at all about our certifications and training programs.