Press Release: Ensuring Minimum Variance in Fill Counts for Solid Oral Dosage Forms

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					Compliance Insight, Inc.


          Ensuring Minimum Variance in Fill Counts for Solid Oral Dosage Forms

(Fairfield, Ohio) Compliance Insight Inc., a regulatory and quality assurance consulting firm,
explains how minimum variance in fill counts for solid oral dosage forms is easily possible
with the use of high-quality equipment. Solid oral dosage forms include capsules, tablets,
caplets, or gel caps, or soft/liquid gels. Modern high-tech equipment includes fill sensors
and in-line check systems to minimize variance. Statistical evaluations of processing would
also help set a practically achievable fill-count target.

The US Food and Drug Administration (FDA) does not specify guidelines for ensuring
minimum variance in fill counts for solid oral dosage forms. However, Troy Fugate, vice
president, Compliance Insight, Inc., offers the following suggestions based on the Code of
Federal Regulations. Pharmaceutical manufacturers may want to consider the following
ideas for solid dosage form processes:

      The best equipment should be used. The equipment should be designed for the
       most accurate output and a high level of efficiency..
      Manufactures should ensure regular calibration and maintenance of the equipment
       so that optimum performance is obtained over a long period of time.
      No compromise on the quality of the equipment should be acceptable..

It is not practically possible to ensure 100 percent accuracy in fill-count targets for oral
dosage forms. However, strict monitoring would keep the variance to the minimum.
Variance in fill count also depends upon the type of solid dosage form being used. Some
factors that depend upon mechanical aspects of the process can be kept in check.
However, certain variables like static charge, dust etc. are cannot be controlled. The idea is
to focus on factors that can be monitored and maintained.

Regular maintenance of equipment for minimizing variance in fill-counts for oral dosage
forms must include:

      Proper equipment evaluation for engineering and processes at regular intervals.
      Conducting regular calibration and preventive maintenance.
      There should be no compromise on equipment quality keeping industry standards in
      All processing should be monitored on a daily basis.
Some manufacturers make the mistake of setting an accuracy target of less than 100
percent based on the notion that a certain amount of variance cannot be prevented.
However, this leads to a greater variance. The accuracy target should remain 100 percent.
Strict monitoring then leads to minimum variance from near-perfect fill counts. In fact, a
general assessment of fill-count results with the best equipment used by pharmaceutical
manufacturers over the last two decades has shown that 100 percent fill counts can be

Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and
training for pharmaceutical, nutraceutical, medical device, chemical, and bio-technology
companies in North America, Europe and Asia.

For more information visit

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