what a manufacturer of solid oral dosage forms should expect … may 2... · 2018-05-21 · the...
TRANSCRIPT
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
®
What a Manufacturer of Solid Oral Dosage Forms Should Expect from Industry
1
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
The Basic “Tickets” to Entry for Our Industry
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Colorcon Believes You Should Expect More
nformation contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
50 Years of Partnering With Customers And Responding to Changing Needsg to Changing Needs
The information contained in this presentation is proprietary to Colo
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
The EXCiPACT Certification Provides ColorconWith Independent Validation of cGMPs
“Patient Safety Through Supplier Quality” Minimal Overall Costs For Assessing The Excipient Supply Chain
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
The Goal = Consistency Reliable Product Quality
Expect and Request…More Than The Minimum
Expect and Request... More Than The MonographMMM
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Expect and Request More Than The Minimum
Partner With Suppliers Who Can Establish Critical Material Attributes on the Incoming Raw Materials
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Look For Suppliers With Partnerships Along the Entire Supply Chain
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Seek Out Suppliers Manufacturing Under Statistical Process Control
Reliance On “In House Expertise” Is Not Sustainable
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Select a Supplier That Works to Meet The Needs of Many Markets
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Partner with Suppliers Acting Upon Continuous Improvement Programs
Expect Lot to Lot and Drum to Drum ConsistencyD C i t
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
®
How Can You Come To Rely On These Things?
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Work to Go Above and Beyond The Monograph!
13
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Begin With Raw Material Control!
• A Functional Attribute.
• An Impurity Attribute.
• A Risk Mitigation Program.
• A Second Source!
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Begin With Raw Material Control!
A Functional Attribute
Working to reduce
incoming variation
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
An Impurity AttributeBegin With Raw Material Control!
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
A Risk Mitigation Program
Begin With Raw Material Control!
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Begin With Raw Material Control!A Second Source!A Secon
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
®
Process Control In Our Facility
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
With Lean Six Sigma, We Find The Waste!
• Engineer Out The Variability.• Control The Plant
Environment.• Engineer In The
Reliability.• Implement Data
Historian System.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
With Lean Six Sigma, We Find The Waste!Engineer Out The Variability: Control The Plant Environment
55 58 65 72 79 89
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
With Lean Six Sigma, We Find The Waste!Engineer In The Reliability:
Implement The Data Historian System
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
®
Critical Material Attributes
Ones that make great tablets or capsules!
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Establishing Critical Material Attributes On The Finished Product
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
“Functionally Related Characteristics”
25
Excellent Powder Flow For The Formulator and the Production Floor of the Customer
PSD and FLow
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
“Functionally Related Characteristics”
26
Compressibility To Result in a Robust Tablet
LOD
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
“Functionally Related Characteristics”
27
Excellent Binding Characteristics
CWS
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
®
Sustainability Measures
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
BCP?
29
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Assess Risks To Sustainability
Dedicated Efforts Towards Metal Mitigation
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
®
External Recognition
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
External Recognition of Quality and Process Control
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Continuous Improvement
33
ExciPACT Certified
ISO Certifications
IPEC GMP
USP Monograph
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
How Did We Get Started?
34
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
How Did We Get Started?
35
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
How Did We Get Started?
36
Tablets and Capsules Continue to be the Preferred Dosage FormStill 88% of The Market Project in 2019
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
How Did We Get Started?
37
3000 Customer Contacts Identified CMAsCompaction, Flow, and Moisture
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
How Did We Get Started?
38
Of 3000 Customer Contacts 70%+ Communicated That They Would
Explore a Co-Processed Excipient To Get Consistency
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Aren’t We Perfect?
39
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Aren’t We Perfect?
40
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
®
It’s the Corn’s Fault!
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
We Blamed The Corn For Our Issues!
42
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
“Naturally Derived Products Are Too Variable”
43
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.44
“Our Equipment And Process Is Outdated”
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.45
“We Will Always Be Dependent Upon the Weather”
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.46
“What We Do Here is More Art Than Science”
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Are We Here to Help Our Customers Make Good Tablets or What?
47
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Are We Here to Help Our Customers Make Good Tablets or What?
48
Yes!
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
We Get Beyond The Monograph!Deliver Consistent Product by Controlling 3 CMA’s
Particle Size Distribution
Cold Water Solubility
Loss on Drying
USP Monograph Specification 25 - 100%
USP Monograph Specification 0 - 14% USP Monograph
Specification 10 - 20%
Starch 1500 with consistent1. Flow2. Compressibility3. Binder Performance
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Challenges of The Future
• ~50 Years of Adding Functionality to Tablets and Capsules
• The Ability to Share This Information (And More) Drives Our Internal Programs
• Formulators Will Face A Future Of Increasingly Strict Regulatory Environment
• Requirements To Demonstrate Process Control On The Supplier Will Be Greater Than Ever Before