The Guide for Increased Accuracy in Fill Counts for Solid Oral Dosage Forms

							The Guide for Increased Accuracy in Fill
Counts for Solid Oral Dosage Forms
There are no specific regulations from the Us Food and Drug Administration (FDA) related to achieving
accuracy in fill counts for solid oral dosage forms. But that has not stopped Troy Fugate, a
knowledgeable industry observer and consultant who acts as vice president of Compliance Insight, Inc.,
from encouraging pharmaceutical manufacturers to consider some specific methods for gaining
improved accuracy.

A careful reading of the Code of Federal Regulations determines that they put forward the following
ideas:

•        Purchase equipment with the end in mind and choose only one that is designed to produce the
level of accuracy you desire

•       Accurate calibration and diligent maintenance of equipment is necessary for manufacturers to
gain optimum performance

There is no doubt after reviewing these Code of Feral Regulations interpretations that the onus on
manufacturers is to only get the best equipment they can. Equipment quality and maintenance levels
are the key according to Fugate for the efficient operation of the packaging equipment. It is realistic to
expect some variance given the properties of mechanical equipment.

Packaging a tablet can produce a different variation then packaging a capsule, as can different operating
setups. However it is possible for manufacturers to exert control over them to produce good results. But
elements such as static charge and dust are not able to be manipulated. Therefore it’s prudent to work
on the elements that you can influence to get the results desired.

Effective maintenance must include:

•       Consistently measuring the equipment processes and performance

•       Focusing maintenance on calibration and prevention to achieve high performance

•       Do not compromise on industry standards in selecting

•       Do not underestimate the importance of monitoring processes

Pharmaceutical manufacturers that want to achieve success must start with the end in mind. Fugate
takes the position that despite the realty that mechanical equipment with produce variance, the best
performance actually is obtained by aiming for 100 percent accuracy. This pursuit means strict controls
are necessary.
It is important to set appropriate fill-count targets. The best method to set reasonable and practical fill-
count targets is to employ statistical sampling based on processing results. Sometimes setting a strict
target does not produce the best performance. However to achieve the most desirable outcome, it is
best to bring together both a target from the statistical sampling work with careful monitoring of
processes and equipment. The goal is always to seek minimum variance from the fill-control targets.



Author: Beth James



Pharmaceutical compliance resource website: http://compliance-insight1.com/



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