Euro Commission Issues New Guideline for Quality Documentation Needed to Support Biologic Investigational Clinical Trials
Addressing quality requirements of an investigational medicinal product for a given clinical trial without sharing…
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.
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:
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?
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.
For a free download of the entire webcast recording click here
To read the complete free transcript click here
Learn More: How to Create an Effective and Compliant Batch Record Review Process – Webcast-On-Demand with BONUS material – includes Batch Record Review SOP, Rounding and Significant Figures SOP and Batch Record Review Checklist. – click here