Quality is the number one criteria in any pharmaceutical business. It is important to implement the concept of quality by design (QbD) in order to ensure consistent quality across all the products.
QbD is a systematic approach to development which begins with predefined objectives and emphasizes product and process understanding, and process control, based on science and quality risk management. It enhances the assurance of a safe, effective drug supply to the consumer, and promises to improve the manufacturing quality performance in a significant manner. However, Quality by Design means that the process and product performance characteristics are scientifically designed to meet the specific pharmaceutical objectives and are not just empirically derived from the performance of test batches.
Since weighing is one aspect that can greatly influence the quality of a pharmaceutical product, it is important that it be considered a part of QbD processes in pharmaceutical manufacturing.
These are the 4 factors that every pharmaceutical facility must consider in order to make weighing processes effective:
Choosing the Right Weighing Scale
The very first thing that you need to achieve accurate and effective weighing practices is having the right tools. Choosing a high-quality weighing instrument will minimize errors and ensure adherence to the stringent industry standards. The right analytical balance also helps in improving accuracy, reliability and allows for real-time adjustments to manufacturing tolerance deviations.
Make the choice based on the industry requirements and tolerance. Consider risk analysis benchmarks too as narrower tolerance levels lead to higher requirements for qualified weighing equipment.
Scale readability or display resolution of the weighing scale is a crucial factor to consider, but, don’t mistake it for instrument accuracy. Regardless of which measuring device you use, be it a scale or a speedometer, it will be associated with some measurement uncertainty.
The uncertainty can be affected by numerous factors —sensitivity, readability, non-linearity, repeatability, and eccentricity of the scale. Even the environment in which it is used can impact the measurement uncertainty.
This is why you need to set up and calibrate the scales properly. Choose instruments that offer highly readable displays but ensure that the readings are accurate. Consider all the factors that affect the measurements and set up accordingly. Regular calibration of weighing scales ensures accuracy every time you use them.
Be Aware of the Weighing Scale’s Limitations
While weighing scales can greatly simplify and automate the weighing processes, you cannot expect it to achieve every single weighing objective. There will be some limitations of the weighing scale. It is important to be aware of such limitations so that you can find ways to overcome them without affecting the accuracy of various pharmaceutical steps and the quality of the final product.
Ill-calibrated or the wrong kind of equipment will affect the accuracy of the measurements. By automating the weighing process, you can reduce the risk of human mistakes to a great extent. However, several pharmaceutical processes like the weighing of formulation materials involve manual tasks which cannot be automated easily. This makes it tricky to ensure the quality of the product and process safety during the manual weighing processes.
Test the weighing scales in their working environment to measure and record any deviation through either manual or automated documentation. You can then take these parameters into consideration during the monitoring process for eliminating the errors.
Calibration of weighing equipment is necessary as it assures the greater accuracy of the processes. It helps in detecting deviations and enables adjustments to correct those deviations. Determine a suitable calibration frequency so that the weighing scales always rank high on performance, efficiency, and accuracy.