Dr. James Blackwell, Ph.D, M.B.A discusses how the COVID-19 pandemic has caused significant changes, both disruptions…
The following answer to the question “Is there a requirement what needs to be included the batch record? I am asking from a standpoint, if most of the information can be captured in the SOP for performance, does it need to be reflected in the record? And why?” is taken directly from a question that was asked after The Windshire Group’s webcast, “How to Create an Effective and Compliant Batch Record Review Process Expert Panel Discussion”
Deborah Miller: There is no single way to design a batch record. You can look to the regulation at 21 CFR 211 for the production and process control documentation requirements to help you decide for your batch record.
- 21 CFR 211.100 (a) There shall be written procedures for production and process control design to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in subpart F – Production and Process Controls
- (b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance.
The procedures and the batch record should be designed such that all requirements in 21 CFR 211 Subpart F are described and documented at the time of performance, in such detail to ensure that “the drug products have the identity, strength, quality, and purity they purport or are represented to possess.”
In addition the batch record needs to have traceability to all raw materials, components, equipment, labeling, packaging, testing, environmental monitoring, personnel and the specific acceptance/ qualification requirements of each.
The batch record must have sufficient detail to link it to the entire “preparation of drug products.”
As you design your batch record ask yourself this question, “How do we show that …?” Examples:
- “… this raw material was received, accepted, stored and issued in accordance with our requirements?”
- “… this person was trained and qualified to perform this task?”
- “…the operator performed the action as required
- “… the equipment was cleaned and passed acceptance criteria before use?”
- “… this time period is within process requirements?”
- “… environmental monitoring was completed and had acceptable results during this production step?”
- “… this sample for in process testing was collected correctly and the test was performed in accordance with requirements and met acceptance criteria?”
- “… labels were received, accepted, controlled, issued, and reconciled in accordance with specifications and acceptance criteria.
In answering this type of question you never want the answer to be, “it’s understood because it is in the SOP.” You must be able to show an unbroken, unambiguous chain of recorded data that you can follow to uphold the totality of each manufacturing order (batch). The SOP can describe the action as detailed as required and the batch record must show the input/output of that action and link back to the SOP.
If the batch record has limited text related to performing the tasks does that mean you expect operators to perform tasks as trained and qualified without routinely referring to the SOPs real time or are the operators expected to be following the SOPs as they are performing the actions?
- If the personnel are expected to be qualified to perform the actions that are not defined in detail in the batch record then I would look for extensive training and qualification to include some type of documented OJT, preceptor observation, or other all-encompassing training and evaluation (testing) to ensure that a trained qualified operator can perform the actions correctly, repetitively, (unsupervised if that is the norm) and with acceptable results. Requalification on a periodic basis and after changes to the process are an important part of this scenario.
- If the personnel are expected to follow the SOP while performing the task then I would observe to ensure that they are actually doing that and their place in the SOP matches the action they are performing.
It will be up to you to decide what you include in the batch record and what you link to the batch record to have confidence in your production and process controls and to show that you have the necessary procedures and records in place to demonstrate compliance.
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