How Accurate are Fill Counts for Solid Oral Dosage Forms? This is an important question facing pharmaceutical manufacturers. This presentation proposes to address this challenge.

1. How Accurate are Fill
Counts for Solid Oral
Dosage Forms?

2. It Can Be Done
In the past 25 year companies have achieved 100%
efficiency
Must maintain equipment
Companies seek to achieve a 100% all the time
Variance is typically always present

3. It Happens All the Time
Not abnormal for variance in fill counts
Also referred to as process capability
Troy Fugate, vice president, Compliance Insight, Inc.
recommends using process-based statistical sampling

4. Troy Fugate
He says that companies ought to focus on
Control
Understanding
Qualification of manufacturing equipment

5. Simple Not Enough
Setting a stringent fill-count target is not enough
Low fill control targets are required to be in
accordance with both
Current Good Manufacturing Practices (cGMPs)
US Food and Drug Administration (FDA).

6. No Specific Target
cGMP does not have specific targets
FDA has not published any related documents
Fugate draws the following ideas by reviewing the
Code of Federal Regulations:
Design equipment to maximize efficiency for its core
purpose
High performance equipment requires regular
calibration and maintenance

7. Crystal Clear
Message is clear if pharmaceutical manufacturers are
serious about reducing variance in fill-counts
1. Choose good equipment
2. Set clear operational and maintenance policies

8. Additional Factors
Mechanical equipment produces variable results
The count can very if:
It's a capsule or tablet dosage form being packaged
If equipment maintenance is good or poor quality
Operational set up
These factors can be controlled

9. Out of Our Control
“Not all factors can be controlled,” says Fugate
Example
Static charge
Dust
Those are essentially impossible to control even with
the best equipment

10. Ethics
Pharmaceutical companies adhere to ethical
standards
Encompass both selection of superior equipment and
a commitment to maintenance excellence.

11. Important Processes
Important maintenances processes include:
Calibrate and maintain equipment proactively
Use process studies or engineering to evaluate
equipment quality
Refuse equipment that doesn’t meet industry standards
Review results regularly to make sure they meet your
goals

12. High Standards
Don’t accept any variance from the target fill
objective
Some variance will occur
Aim for 100%
Set stringent acceptable tolerance levels to ensure
good results

13. 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/