The next logical item would be ensuring the raw material supply chain is viable for the ingredients in the Brand Owner’s product. While most contract manufacturers do not freely share that information, it only shows the weakness of the partnership if each side doesn’t trust
each other. The raw material information is truly confidential. Additionally, if disclosed or used by the Brand Owner for something other than a verification of the ingredients used in the product, it violates a number of signed agreements between the parties. Information exchanged between the parties concerning potential supply chain interruption can lead to even a greater cooperation. The CMO should be aware of potential supply chain issues and relate those to the Brand Owner. By working closely together you can pre-empt supply issues allowing the CMO to secure critical components for key products before the market goes haywire. This level of partnership can only arise when the transparency is in place.
Ultimately, this transparency can bring us full circle to the critical regulatory gap caused by Covid-19, which is the inability to do an on-site audit the contract manufacturer. The new reality is that onsite audits may not be possible for the foreseeable future. However, technology has led to the concept of a “virtual audit,” which might remain a part of our businesses even after Covid-19 is defeated. Organizations like the Global Retail Marketing Association (GRMA) are working with auditing firms to establish policies and procedures for virtual audits. This enables the Brand Owner to contract with qualified audit groups to satisfy their need to visually inspect the CMO to ensure compliance to regulations. With all of the supply chain challenges today, this approach can also be used by the CMO to meet the requirement to audit/inspect new raw material suppliers anywhere in the world.
With the Virtual Audit platform and procedures established, this should be used by the Brand Owner’s Quality Team to do a “deeper dive” into a product or process outside of the services offered by a third party. With access to batch paperwork and the ability to visually “eyeball” documents (such as raw material test results or raw material supplier audits) which ordinarily are available during the audit but cannot leave the facility, the Brand Owner can quickly and inexpensively manage the most critical part of the relationship from afar. It also might allow additional Brand Owner Quality Staff participate in the Virtual Audit, as the expense of travel and the time away from the office has been eliminated.
With the accessibility of this technology and a strong quality relationship in place, the transparency the Brand Owner should expect in the relationship will be apparent – or the Brand Owner will realize they should be searching for an alternative partner.
Copyright © 2025 Gemini Pharmaceuticals. All rights reserved. Read our Privacy Policy.