Frequently Asked Questions about Batch Records

Q. What is a master batch record (MBR)?

A.The MBR is the controlling document for product manufacturing. It contains the instructions and specific manufacturing processes needed to produce a particular product. The MBR ensures the ingredients needed to produce a product are correct; added in the correct order; and the mixing, stirring, or other activities used to produce the product are conducted in the correct sequence. For example, the MBR would list an ideal ingredient amount for the product, while the completed batch record would indicate the actual amount used for the individual batch. Batch records are a requirement of 21 Code of Federal Regulations (CFR) 211.188, Batch Production and Control Records.

Q. Who is responsible for issuing the batch record to production?

A. Most companies have a document control department that is responsible for issuing the MBR to production. This department may or may not report to the quality department. The most important item to remember about releasing the batch record to manufacturing is that it needs to be tied to an actual production run. The link that ties the MBR to the completed batch record is the lot number assigned to the product being manufactured. Each manufacturing run must have a different lot number for traceability and recall purposes.

Q. Can I release a batch record that has open investigations/deviations associated with it?

A. The regulation, 21 CFR 211.22(a), states, “There shall be a quality control unit that shall have the responsibility and authority to approve or reject … drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated” (1). The errors referred to include errors that occur during the manufacturing process. If you are releasing a product that has a batch record associated with an open deviation/investigation then, in my opinion, the “error” has not been thoroughly investigated. The bottom line is, I would not recommend this practice. In my opinion, there is too much risk associated with releasing a product to the field with open investigations or deviations because, if the investigation result indicates the product has not achieved the specified quality attributes, by releasing it you have not only risked patient safety but you are facing a recall situation.

Q. In what order should I review batch record information?

A. I think we need to be clear on what we are discussing when releasing the batch record. It includes a review of the incoming raw materials that include the active ingredient(s), excipients, primary packaging, and labeling. The batch record process should verify these items were properly received, sampled, and put into quarantine until the incoming quality group established their suitability for use. This includes testing of the water that might be used in manufacturing the product. The review should confirm that all the materials used were appropriately discharged using calibrated equipment in a suitable environment and that the manufacturing rooms were properly cleaned and cleared before the start of the batch. The main focus of the picture should be the details of the batch manufacturing itself. Attention needs to be paid to make sure that any deviations during this phase of production have been resolved. It is also important to make sure that operators signed (this could be electronically) in the appropriate places indicating they performed the work. If required, there should also be an indication that another employee or a supervisor witnessed the work. This is particularly important when verifying the right ingredients were discharged to the line to make the right product with the right dosage amount. Many companies use a checklist to make sure all the elements of the master batch record are included in the product batch record. This is an acceptable practice and, when coupled with a thorough review of the contents of those elements, you should confidence in releasing product batches.

Reference

1. 21 CFR 211.22(a).

About the author

Susan J. Schniepp is distinguished fellow for Regulatory Compliance Associates.

Article details

Pharmaceutical Technology
Vol. 46, No. 12
December 2022
Pages: 34

Citation

When referring to this article, please cite it as S.J. Schniepp, “Frequently Asked Questions about Batch Records,” Pharmaceutical Technology 46 (12) (2022).