GMPs and Audit Formulations
It is important for supplement brand owners to keep communication lines open with their contract manufacturers, and audits are a good way to ensure a positive relationship, as well as to ensure quality of products and overall productivity.
This slide show was adapted from “Tips for Successful Audits of Contract Manufacturers.”
Good Manufacturing Practices (GMPs)
GMPs (good manufacturing practices) are practices presented by FDA to ensure the quality and purity of dietary supplements. Marketers or own-label distributors are responsible for following current GMPs.
FDA and third-party certifiers typically perform audits; however, companies can perform their own vendor audits. Audits cover a variety of areas including personal, labeling operations, distribution and more.
Audit Notification and Agenda
Auditors can choose the areas they’d like the audit to focus on, however they should make sure to find a mutually agreeable date with the vendor as to not take the vendor by surprise. Auditors are then required to send the vendor the decided agenda, and it is common for audits to go past the scope of the agenda.
During the Audit and Exit Interview
During an audit, an auditor should not be trying to catch the vendor doing something wrong, but instead should be trying to understand the way the vendor works. He or she should examine work procedures, employees and documentation. The exit interview will help clear up any miscommunications and reveal how open the vendor is to improvements.
Vendors Preparing for an Audit
If you are a vendor preparing for an audit, is important to keep everything documented. All documents should be retrieved easily, and performing self-audits in a regular basis can prepare the facility and employees for a real audit. Vendors should make sure to partake in the exit interview to discuss any findings or misunderstandings.
Once a vendor has received the final report, it is important they follow up and respond immediately to any corrections. Audits help strengthen customer/vendor relationships, so being compliant will ensure a quality product in the long run.
For More Information
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