21 CFR Part 11: Electronic Batch Records

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding 21 CFR Part 11 and electronic batch records.


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


21 cfr part 11A. The MBR is the controlling document for pharmaceutical manufacturing. It contains the instructions and specific manufacturing processes needed to produce a particular product.


Additionally, the MBR ensures the ingredients needed to produce a product are correct. Each ingredient is added in the correct order, and the mixing and stirring used to produce the product are conducted in correct sequence.


Master Batch Record


For example, the MBR would list an ideal ingredient amount for the product. The completed electronic batch record would indicate the actual amount used for the individual batch. Moreover, electronic batch records are a requirement of 21 CFR Part 11 and is listed in Batch Production and Control Records section.


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


A. Undeniably, world class 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. Simultaneously, the most important item about releasing the batch record to manufacturing is that it needs to be tied to an actual production run.


21 CFR Part 11 Requirements


The pharmaceutical industry has very specific compliance requirements tied to traceability. The link that ties the MBR to the completed batch record is the lot number assigned to the product being manufactured. Naturally, 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 21 CFR Part 211 regulation 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”.


Consequently, the errors referred to include errors that occur during the manufacturing process.


Batch Production Record


If you are releasing a product that has electronic batch records associated with an open deviation/investigation then, in my opinion, the “error” has not been thoroughly investigated. Therefore, the bottom line is I would not recommend this practice.


21 CFR Part 11 Audit Trail Requirements


Unquestionably, audit trail documentation is vitally important when assessing risk if production goes awry. In my opinion, there is too much risk associated with releasing a product to the field with open investigations or deviations. Further, if the investigation result indicates the product has not achieved the specified quality attributes, by releasing it you have risked patient safety and may need to recall.


Q. In what order should I review information from electronic batch records?


A. I think we need to be clear on what we are discussing when releasing the batch record. Certainly, it includes a review of the incoming raw materials that include the active ingredient(s), excipients, primary packaging, and labeling.


21 CFR Part 11 Compliance


The batch record process for 21 CFR Part 211 compliance should verify these items were properly received and sampled. Nevertheless, each item should be put into quarantine until the incoming quality group established their suitability for use. Finally, this includes testing of the water used in manufacturing the product.


Critical to Quality


The review should confirm that all the materials used were appropriately discharged. Equally important, using calibrated equipment in a suitable environment. Without a doubt, cleaning manufacturing rooms before the start of the batch is critical to quality (CTQ).


FDA Electronic Signatures


The main focus of 21 CFR Part 11 compliance should be the details of the batch manufacturing itself. For instance, attention needs to be paid to make sure that any deviations during this phase of production have been resolved. In contrast, it is also important for FDA electronic signatures to ensure operators signed in the appropriate places indicating they performed the work.


21 CFR Part 11 Summary


Finally, there should also be an indication that another employee or a supervisor who 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.


Lastly, 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 a widely accepted current good manufacturing practice (CGMP) in the pharmaceutical industry. Therefore, you should have confidence in releasing product batches when coupled with a thorough review of the contents. 


Article details


21 cfr part 11






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


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