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Informa Insider Article by Gemini – You Have the Batch Record, Now What?

Transparent relationships help educate and empower a company’s quality team

Gone are the days when the brand brand owner or own-label distributor could abdicate the responsibility for the quality of its products to the contract manufacturing organization (CMO). Also gone are the days of the CMO saying “what we do is secret or proprietary” when it comes to sharing production and quality information with their customers; companies can no longer claim a “confidential” item is beyond the scope of an audit of their product.

With the evolution of current good manufacturing practices (cGMPs) and FDA enforcement, most brand owners today invest in their quality systems to ensure compliance. From on-site audits to batch paperwork, brand owners are instituting policies and acquiring data from CMOs, which is mandated by FDA. However, even after spending money and hiring a qualified quality staff, most brand owners are still unprepared for the moment when an auditor asks specific questions about a specific lot of its product.

Along those lines, it is popular in various quality agreements for the CMO to provide manufacturing or batch records to the brand owner either during an on-site audit or upon the request of the brand owner.

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