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You Have the Batch RecordNow What?

Brand owners are investing in their quality systems, but most are still unprepared for an auditor’s detailed questions about a specific product lot.

Gone are the days when the 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.

While this might seem to be a simple secretarial task, it is important that the brand owner understand these documents. An unprepared brand owner will likely be unable to explain what the paperwork means, and how it all fits together within its quality system. 

For instance, an FDA auditor may require the brand owner to produce information for XX lot during the course of an audit. This inquiry is likely motivated by a specific purpose, so every answer will be critical.  

However, without the necessary understanding of that paperwork, the uninformed presentation of this document and the quality member’s inability to talk about any specifics will certainly cause the situation to escalate into other batches, items or areas.

Think about this: Within the time frame between a request for paperwork and its presentation, the brand owner’s quality team will be responsible for re-familiarizing themselves with the 20-plus page document, and they must also provide that copy to the auditor—plus, they are expected to answer questions about the batch. Specifically, questions may arise about the testing procedures, yield calculations, deviations, etc.

Without the brand owner’s quality team having a working knowledge of the documents, it would be impossible for anyone to demonstrate the necessary understanding of the entire quality process. This certainly will not inspire confidence in the eyes of the auditor. 

Along the same lines, and through recent warning letters, it’s clear FDA is now mandating brand owners be a second set of eyes for everything made by its manufacturing partner. The cGMPs require brand owners to provide for the release of their products to the marketplace, so brand owners cannot hide behind the paperwork provided by the CMO—they are responsible for knowing what’s there and the potential impact on their products.

A strong quality agreement between the CMO and the brand owner is a necessary first step to empower the brand owner’s quality team with all the necessary information and training to perform the task. However, the brand owner must incorporate those same responsibilities into its own systems to ensure a seamless quality relationship with its CMO. 

Reviewing the audit situation above, the brand owner’s quality team would satisfy any auditor by demonstrating not only a working knowledge of how a batch record works, but also by presenting that the quality team member has been trained on the CMO’s procedures and batch records, and that he or she can speak from a position of authority.

This level of partnership goes well beyond the traditional audit and basic certificates of analysis (CoAs), which are industry norm. It proves to any auditor the brand owner has aggressively interpreted the cGMP requirements between the CMO and brand owner, has a transparent partnership in place with the CMO, and has expended the resources to ensure cGMP compliance.   

Armed with specific training and the ability to discuss batch paperwork and other quality documents provided by the CMO, brand owners will have an unparalleled level of security and confidence in their quality systems. This, coupled with a strong quality/manufacturing agreement, will significantly reduce compliance costs and mitigate the stress of having to present this information to any auditing body.

In a sense, the brand owner is really an advocate for the CMO in any audit situation. Consequently, preparing the brand owner’s quality team for the inevitable questions they will face is not only an integral part the relationship the brand owner must have with its CMO, but also a responsibility the CMO must willingly undertake.

View the INSIDER Gallery “Transparency in Partnership" for more on maintaining solid, transparent partnerships.

Michael  Finamore is CEO of Gemini Pharmaceuticals Inc., a contract manufacturer of both dietary supplements and over-the-counter (OTC) pharmaceuticals for more than 30 years. All Gemini production is carried out in pharmaceutical cGMP environment.

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