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The Process to Ensure Minimum Variance in Fill Counts


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Ensuring minimum variance in fill counts for solid oral dosage forms is easily possible with the use of high-quality equipment and a clear process. Discover how to adopt a productive approach.

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The Process to Ensure Minimum Variance in Fill Counts

  1. 1. The Process to EnsureMinimum Variance inFill Counts for SolidOral Dosage Forms
  2. 2. Introductionensuring minimum variance• Easily possible with the use of high-quality equipment• Solid oral dosage forms: • capsules, tablets, caplets, or gel caps, or soft/liquid gels• 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
  3. 3. Current Environmentensuring minimum variance• The US Food and Drug Administration (FDA) does not specify guidelines for ensuring minimum variance in fill counts for solid oral dosage forms
  4. 4. Compliance Insight, Inc.Specific Recommendations• The best equipment should be used • designed for the most accurate output and a high level of efficiency• Manufactures should ensure regular calibration and maintenance of the equipment • maintain optimum performance over a long period of time• No compromise on the quality of the equipment should be acceptable
  5. 5. Realityensuring minimum variance• Not practically possible to ensure 100 percent accuracy in fill-count targets for oral dosage forms• Strict monitoring will keep the variance to the minimum• Variance in fill count - dependent on the type of solid dosage form being used• Some factors that depend upon mechanical aspects of the process can be kept in check• Certain variables like static charge, dust etc. cannot be controlled• Focus on factors that can be monitored and maintained
  6. 6. Maintenance Recommendationsensuring minimum variance• Proper equipment evaluation for engineering and processes at regular intervals• Conducting regular calibration and preventive maintenance• There should be no compromise on equipment quality • keep industry standards in mind• All processing should be monitored on a daily basis
  7. 7. Mistakesensuring minimum variance• Manufacturers make the mistake of setting an accuracy target of less than 100 percent • mistaken notion: certain amount of variance cannot be prevented• Problem - leads to a greater variance• Accuracy target should remain 100 percent
  8. 8. Insightsensuring minimum variance• Strict monitoring leads to minimum variance from near-perfect fill counts• 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 obtained
  9. 9. Compliance Experts• Compliance Insight, Inc.• Your Hands-On Quality and Regulatory Specialists• Our services include GMP consulting, audit preparation, FDA mock inspections, FDA response assistance, vendor/contract audits, GMP training and accreditation, new construction compliance, regulatory consulting, investigations, biosafety and viral testing consulting; clinical trial audits and more.• For more information visit