Master Production Records (MPR) are the foundation for all good manufacturing practices. While sometimes referred to by a variety of other names (Master Records, Master Manufacturing Formulas, Master Formula Records, Master Manufacturing Records and Master Batch Records), MPRs outline the required control steps during the manufacturing process. In the simplest terms, if there was a recipe for manufacturing a product, an MPR would fill that role.
Although it has a similar name (and is often confused with an MPR), a Batch Production Record (BPR) serves a different purpose. Using an MPR as its roadmap, a BPR is the document where operators record every step they take during the production process. By following the process that is defined in the MPR and recording each step in the BPR, operators ensure that all necessary actions are completed and all essential materials are used during the manufacturing process.
But sometimes, things change during the process. These changes are called deviations since they depart from the control steps outlined in the MPR. While this term may sound alarming, it is actually part of the manufacturing process. Deviations are acceptable as long as it is defined, recorded in a deviation log and reviewed by a quality specialist. Above all, deviations can help improve the manufacturing workflow process and help produce a better quality product.
In the following article, we’ll provide an example of a GMP deviation, outline the process to determine if the change is necessary, and demonstrate how the Quality Management System included in InstantGMP™ PRO software can simplify deviation management and help improve your workflow process.
What Causes a GMP Deviation?
As we mentioned above, deviations are a common occurrence during the manufacturing process. Although operators follow the required control steps that are defined in the MPR and record them in the BPR to ensure quality and consistency, things can change during the process. That’s a deviation.
Let’s look at an example of a typical GMP deviation. During the manufacturing process, an operator proceeds to the next control step outlined in the MPR. This step states that the operator should mix the product materials for five minutes. The operator follows the step, mixes the materials for the required time, but at the end of the step the materials do not look right. The current state of the materials doesn’t appear consistent with the previous batches.
Instead of proceeding to the next step, the operator notifies his supervisor about the inconsistency. After speaking with the operator and reviewing the materials, the supervisor will approve additional mixing time and notify the operator to define this change in a deviation log. Then, a quality specialist reviews the deviation to verify if the change is necessary.
This is the start of the process improvement workflow – and this is where our Quality Management System can be of assistance.
Process Improvement Workflow
If there is a need to make a change in the MPR, manufacturers can rely on the Quality Management System included in InstantGMP™ PRO software to make the process improvement workflow more efficient and effective.
Using the QMS, operators can create a deviation log to record a change and set the process improvement workflow in motion. Once their change is logged, a quality specialist assesses the risk or impact of the deviation and opens an investigation.
The purpose of the investigation is to determine the root cause of the change. In the example detailed in the previous section, the root cause of the longer mixing time is determined to be a change in the materials. The investigation reveals that the material supplier has produced a more granular formulation that takes more time to dissolve.
Since the material is more coarse than the previous materials used in the process, the investigation identifies and confirms the need for a longer mixing time to eliminate the root cause. Rather than simply extend the time by a few minutes, the specialist creates a Corrective and Preventive Action (CAPA) plan in the QMS. This plan analyzes various mixing times to determine which duration results in the best material consistency.
After the analysis is conducted under the CAPA plan, the quality specialist decides that changing the MPR to include a longer material mixing time makes sense. This decision is recorded in the Change Control Log feature in the QMS. Once that change is logged, the quality specialist uses the Document Management feature of the QMS to outline an exact set of actions that are needed to change the MPR to reflect the updated mixing control step. These actions are then entered into the Training Log so that all operators are trained on the new process.
Finally, the specialist verifies that the change is effective, which leads to the creation of an updated MPR. This new MPR allows all subsequent BPRs to include the new longer mixing time as a control step which improves the overall manufacturing process.
As you can see, deviations are an extremely important aspect of the manufacturing process. While the name may trigger worries about setbacks and delays, they actually help facilities improve their manufacturing process. And that improvement results in a higher quality product.
While necessary changes do occur in manufacturing processes, deviation management can be difficult tasks. With InstantGMPTM PRO’s built-in Quality Management System, manufacturing facilities can easily and expertly carry out deviation reports and investigations, take corrective actions, and easily update their MPRs and BPRs to improve their workflow process.
To see the InstantGMPTM PRO all-in-one manufacturing and quality system in action, please contact our team for a live demonstration.