Batch records are crucial documents in various industries like pharmaceuticals, biotechnology, food and beverage, and chemicals, where they are used to ensure product quality and consistency. They provide a detailed account of the production process for a specific batch of product, helping to maintain product consistency, and compliance with industry regulations and standards.

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Batch Record review helps to ensure that your product meets regulatory requirements, quality standards and product specification BEFORE the products are released to the market. Batch Record Review can help to avoid costly recalls or the distribution of adulterated products.

Companies that do not follow FDA regulations and cGMPs may lose their product approvals / product registration; or they may lose the ability to import, market or distribute their product in the US. In order to maintain market access companies must keep manufacturing records and they must supply safe, effective, unadulterated products that meet applicable packaging, labeling, and testing requirements.

The manufacturer or license holder is responsible for all products that they manufacture, even if the physical making, packaging, or labeling of the product is done by someone else.

Yes. Our default is to review batch records to FDA GMP Manufacturing standards. If your product requires a less stringent review, please tell us in advance.

Set up a short call where we learn about your product and your specific needs. We take this information and adjust our review process to ensure the correct level of review. We review your batch manufacturing record, raw data, on process testing, final release testing, deviations, nonconformances, etc and complete the batch review form. Upon completing the review, a short batch review summary is complete for the client.

We can host a virtual meeting to review and findings.

If the review process discovers missing data, incorrect data, unmet specifications, illegible records, unmet testing specifications, labeling errors, etc these are documents in the Batch Record Review Form and in the Batch Review Summary. Detailed locations, reason for identifying the gaps, and recommended corrections are included in the batch review documentation.

We take your batch data and upload it to validated external tools. We then present this data to the client to improve process and product understanding. Depending on the data, we should be able to identify trends, material impact, and verify critical parameters.

The FDA mandates that medical device companies establish and maintain a Device History Record (DHR) that contains all documentation related to manufacturing, labeling, test acceptance, and identifying the device, and demonstrates that the device was manufactured according to the information in the Device Master Record (DMR).