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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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 http://compliance-insight1.com/