I’m reaching out to initiate a discussion on the significance of Balance Qualification in the pharmaceutical sector. I’m curious to know if there are specific guidelines regarding Balance Qualification, especially considering that in some pharmaceutical plants, balance calibration is conducted every six months instead. My understanding is that Balance Qualification is imperative in this industry. Could you provide insights into this matter?
While Qualification is a term with a specific definition in regulatory and industry standards, it is widely used in the pharmaceutical with different definitions. I will approach this issue with a more “statistical” approach, instead of a “reuglatory” lexicon.
A balance is considered an instrument and not an equipment; and the risk associated with insturments is that the data measured by them is never 100% accurate, it always falls within an uncertainty range or error. Therefore, if that instrument is critical for product quality (risk based approach), then tests should be done to demonstrate the metrological performance of the measurement system. And this applys to all measurement systems no just balances.
While it is currently expected to perform calibration or verification activities, it is understood that if the risk supports it, the instrument must undergo a full or partial Measurement System Analysis (MSA), which not only includes a calibration test but all different attributes of a measurement instrument that impact variation in the measured data:
I’m sure you’ve heard the term of gage R&R analysis… that test verifies repeatability and reproducibility…
In short. it is a current regulatory expectation that all qualification activities are derived and planned with a risk based approach. And measurement instruments must be risk assessed to conclude which tests are needed: it could be just calibration and stability, or it could trigger a gage R&R test as well. This is all part of a MSA (measurement System Analysis)
I hope this helps.
To be clear… are you talking “qualification” in regards to IQ /PQ?