It’s widely known Pharmaceutical companies spend a huge amount of time and resources purely on documentation. The review and approval of these for each batch alone is a significant effort, requiring hours from multiple highly trained and experienced people. The extent varies depending on the type of production, its complexity, and the tools available. But for the vast majority of pharma, still managing on paper, this creates a significant bottleneck of overall production output.
So how to improve this whilst still meeting all of a company’s Good Manufacturing Practice (GMP) requirements?
We are really asking here: is there a way to automate out the non-value-added work, without jeopardizing the level of quality assurance. Or in other words, to work smarter instead of harder. The answer of course is yes, and there are in fact ways to not only maintain QA levels but improve them, as well as create a Return On Investment (ROI) through the efficiency savings.
GMP requires such meticulous and detailed documentation of processes and workflow executions for a reason. Reviewing all production and control records is necessary so that errors or deviations relating to product quality can be found before the product is sold. These documents may contain hundreds of pages of technical data. It is therefore difficult to manually check for manufacturing errors, illegible entries, missing signatures, or other quality oversights. Hence the time required to do so confidently for something that may impact a patient. It is however crucial to check for these as human error is inherent to repetitive, manual operations, and thus calls for close attention to detail. Another logistical and document control difficulty is effectively transferring these records for reviews and revisions among operators, Quality Control, and Quality Assurance.
What is Review by Exception (RBE)?
A review by exception strategy will automatically highlight any components of a record that do not meet pre-specified standards, replacing the need to manually go through each page of the record to be reviewed. The highlighted data becomes all that needs to be reviewed by the quality assurance team. In this case, the QA only need to review where the problem is (the exception) rather than go through all the processes one by one.
How is that even possible?
One of the most important aspects of digitalization that will improve the efficiency of your GMP processes is Review By Exception (RBE). An agile alert system that replaces the laborious paper-based quality assessment process, allowing staff to concentrate on analyzing and resolving the important issues as they arise. Rather than spending most of their time simply trying to locate them.
With digitalized workflows and interactive work instructions in systems such as an Electronic Batch Record (EBR), can we be sure that all process data is incorporated, and nothing has been omitted?
Prevention is always preferable to a cure, doing things correctly the first time is crucial for effective organizations to avoid corrections taking up operator time or slowing down production. The digitalization of workflows makes it possible to prevent spending time on corrections by instantly checking for missing data or double-checking computations against a specification. This automatically moves a company towards what's called Right First Time (RFT) manufacturing, by error proofing execution steps.
What is BatchLine?
BatchLine is an Electronic Batch Recording system which provides features for electronic workflow creation, sequentially controlled working instructions, Audit trail history, electronic signatures, Review by exception, and report generation. BatchLine can integrate data from a weighing scale and ERP through a weighing and dispensing add-on, or from devices (temperature, humidity etc.) through IoT technology.
Making the switch to a digital workflow will save you tons of time if your business currently uses a paper-and-excel-based recording system, and your job involves sifting through mountains of documentation. Allow your team to focus on value-added activities such as problem-solving or error prevention rather than document reviews, by freeing up their experienced minds for more valuable work in R&D or data analysis.
Ririn Afrianti, Compliance Consultant
Reduce time and effort during batch review and approval with review by exception