Discover how to achieve accuracy in fill counts


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Discover how to achieve accuracy in fill counts. Learn simple guidlines to improve performance.

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Discover how to achieve accuracy in fill counts

  1. 1. Accuracy Level FDA has not issued guidelines to address accuracy level in fill counts of solid oral dosage forms Smart pharmaceutical manufacturers seek best methods Industry expert Troy Fugate from Compliance Insights, Inc. has specific recommendations
  2. 2. Troy Fugate’s Advice In seeking accuracy, the Code of Federal Regulations advocates these actions:  Purchase equipment with the end in mind and choose one that is designed to produce the level of accuracy you wish  To reach the desired performance, manufacturers are told to carefully calibrate and maintain equipment through regular monitoring
  3. 3. Superior Equipment The Code of Federal Regulations is expecting manufacturers to select superior equipment Fugate insists that manufacturers be very specific about the operation and maintenance of packaging equipment Mechanical equipment by its very nature, will produce variable results
  4. 4. Packaging Packaging a tablet, a capsule, and different operating setups can all lead to packaging variations Manufacturers can exert control over them to produce good results Some things can’t be controlled  Elements such as static charge and dust Work on the elements that you can control to get the desired results
  5. 5. Ways to Increase Accuracy Achieving accuracy requires careful maintenance processes that include:  Monitoring equipment on a regular basis  Focusing maintenance on calibration and prevention to achieve high performance  Purchase equipment that meets industry standards  Do not underestimate the importance of monitoring processes
  6. 6. Try Your Best Dealing with mechanical equipment can lead to the thought that variance is unavoidable  Knowing this should not influence goal setting Fugate says, to gain the minimal variance in fill-count targets in oral dosage forms it is important to aim for 100 percent
  7. 7. Guess Work It is possible to take the guess work out of setting fill- count targets One way is to use statistical sampling of processing results Determines what is acceptable and practically achievable
  8. 8. Better Results A low fill-count variance target will not necessarily produce better results Constant monitoring of processes must be combined with equipment to achieve an optimum target These will produce the minimum variance of fill- control targets
  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