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Risk induced improvement of relationship with contractorsDr. Ingrid Lux, Head Quality Control, Qualified Person Berlin, 14.02.2012
Berlin, 14.02.2012Dr. Ingrid Lux
05 March 2008 CNN.comApril 28, 2008,
The New York TimesEDITORIAL
The Frightening Heparin Case
Researchers Identify Contaminant in Tainted HeparinApril 23, 2008
Berlin, 14.02.2012Dr. Ingrid Lux
How could that occur?
Authority
Counterfeit
FDA
Pharmaceutical company
Manufacturing company API Supplier
Quality Agreement - components -
Berlin, 1402.2012Dr. Ingrid Lux
Denomination of involved parties Scope Definition
Responsibilities listed in a table with clear delimitation between parties
List of contact persons Attachments including technical specifications
Signatures
Advantages and Limitations of a Quality Agreement
Berlin, 14.02.2012Dr. Ingrid Lux
Advantages
Clear denomination of responsibilities
Clear delimitation of responsibilities
Sound focus on GMP and standardized norms
Limitations
No knowledge infusion
No protection against accidental failure or deliberate fraud
No direct impact on operational transformation
FDA findings at concerned API supplier during inspection in April 2008
- quotations -
• “Your firm lacked an adequate evaluation of the effectiveness of critical processing steps designed to remove impurities “
• “You state that the firm received and used heparin crude materials from a workshop that had been designated by your firm in a pre-audit as “unacceptable”.
• “You have failed to conduct adequate verification of USP compendial test methods as applied to the production of your firms API.”
Berlin, 14.02.2012Dr. Ingrid Lux
ICH Q10- published June 2008 -
Berlin, 14.02.2012Dr. Ingrid Lux
Pharmaceutical quality system- Knowledge and quality system
transfer
Management responsibility- Including resource planning
Continual improvement- of process performance, product quality, and pharmaceutical quality
system
International
Conference of
Harmonization
GMP-Guide – revised Chapter 7 Outsourced Activities
Berlin, 14.02.2012Dr. Ingrid Lux
Focus on communication processes
Clear definition of responsibilities reaching out to market impact
Quality system of CG sustained by management
Comprehensive assessment
Continuous and documented control of quality
Audit allowance of CA and its subcontractors
The Supply Chain
Berlin, 14.02.2012Dr. Ingrid Lux
Excipients
BulkManufacturer Packager:
FDF
Warehousing / Transportation
Analytics
Distribution to the market
Active ingredients
Intermediate release Decisions / Contracts
Final Release
Contractor selection process
Berlin, 14.02.2012Dr. Ingrid Lux
Fixed procedure: GOP, SOP, to integrate cross-divisional decision
making
Definition of mandatory steps
Managerial responsibilities:Time critical operations =>
resource planning !
QA-AUDIT
SCM
SCM
Change Control
Evaluation tool
Berlin, 30.11.2011Dr. Ingrid Lux
The Supply Chain
Berlin, 14.02.2012Dr. Ingrid Lux
Excipients
BulkManufacturer Packager:
FDF
Warehousing / Transportation
Analytics
Distribution to the market
Active ingredients
Flow of material
Flow of samples
Intermediate release Decisions / Contracts
Final release
Flow of decisions
Addressing risk in contract manufacturing
Berlin, 14.02.2012Dr. Ingrid Lux
Reactive measuresIncrease monitoring efforts (re-test, follow-ups etc.)
Remove Supplier from authorized list of suppliers
Stop supply / destroy stocks
Recall
Proactive measures
Follow internal process of supplier identification
Follow-up plan with detailed measures of contract partner
Assess investment to enable support
Foster strategic decision on management level
Paradox management
Low prices
Berlin, 14.02.2012Dr. Ingrid Lux
High Quality
Highly regulated markets
Fierce pace of changes
Increased knowledge demand
Decreasing development funds
Berlin, 14.02.2012Dr. Ingrid Lux
Cross-departmental risk classification
BusinessMarket actions like distribution stop or recall affects sales and reputation => business vs. quality
ComplianceDynamic pace of changes may lead to regulatory incompliance => Build-up of strong change control tools
Quality & EfficacyLack of tracking may end in efficacy and safety risk => detailed monitoring steps
SAFETYImmediate action required!
RELEVANCE FOR THE PATIENT
Every time
In timePerformance
Costs
Standards
Quality
Mission
Berlin, 14.02.2012Dr. Ingrid Lux
SANDOZ
Platform of contract manufacturers
MEET EXCEED
Competence Knowledge
Productivity Personal development
Integrate
Berlin, 27 September 2011 Dr. Ingrid Lux 29www.taramtamtam.com/.../images/
Surfing_3.jpg
Selection Strategy
Mission: building and integrating a platform of contract manufacturers in partnerships that meet or exceed the defined quality, costs and performance standards on time, every time, achieved by one global process, building competence and knowledge to ensure maximum productivity and personal development. Interdepartmental communication: setting quality into the frame Quality is not only an intrinsic value, an expected property, but part of the business This is to be reflected in all supplying decisions.