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TRANSCRIPT
FDA Expectationsfor Supplier Quality
Martin BrowningPresident and Co-Founder
EduQuest
2014
FDA Expectations for Supplier Quality
OMTEC® 2014 The 10th Annual Orthopaedic Manufacturing & Technology
Exposition and Conference
© 2014 EduQuest, Inc. 2
Topics
• Setting the scene
• Regulatory Requirements and Expectations
• Protecting your company
– Contracts and Service Level Agreements (SLAs)
– Selecting Partners
– Supplier Preparation for an FDA Visit
– Pitfalls and Critical Issues
– Consequences
• Summary
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The Drive to Outsource
“What can be outsourced?
Everything, except responsibility.”
“By agreeing to supply, the vendor assumes a
whole new level of additional responsibility”
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The Drive to Outsource
Why outsource?
• Cost reduction
• Better focus on “core” business
• Reduce or control personnel “overhead”
• Improve organizational performance
© 2014 EduQuest, Inc.
Regulatory Interest in Supply Chain
Management
• FDA’s Published Goals for 2011 – 2015
– Advance Regulatory Science and Innovation
– Strengthen the Safety and Integrity of the Global
Supply Chain
– Strengthen Compliance and Enforcement Activities to
Support Public Health
– Expand Efforts to Meet the Needs of Special Populations
– Advance Medical Countermeasures and Emergency
Preparedness
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Goal 2: Strengthen the Safety and Integrity of the
Global Supply Chain
• The border must be viewed as a final checkpoint for
preventive controls, rather than the primary line of
defense against unsafe imports.
• FDA must require more (and better) information
about product supply chains and monitor this
information throughout the product life cycle
• Regulatory standards must foster corporate
responsibility to identify, protect, and control risks
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Goal 2: Strengthen the Safety and Integrity of the
Global Supply Chain
• Updated compliance and enforcement tools, a
greater global safety net that includes a global
alliance of regulators,
• Coordination of activities with international
capacity-building and standards-setting
organizations, adequate funding to allow for
inspections, examinations and sample collections
and analysis, and updated systems, including IT
support, to assist with the increased workload. © 2014 EduQuest, Inc. 7
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Regulatory Requirements and Expectations
• The regulated entity, is responsible for
compliance with all of the applicable regulatory
requirements. If you outsource, you are
responsible for the performance of your
outsourcing partners.
© 2014 EduQuest, Inc.
© 2014 EduQuest, Inc.
Regulatory Requirements and Expectations
• “Do unto your suppliers as FDA does unto you”
– Requires a robust quality organization for audit,
oversight, etc. (note that this also can be outsourced)
– Your company’s management (and not just Quality)
must have processes for evaluating and effectively
managing potential partners
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Regulatory Requirements and Expectations
• If you outsource you are still responsible for
assuring that all required activities are performed
and documented. Monitoring is critical, so
typically a more robust quality organization is
needed for audit, oversight, etc. (note that this
also can be outsourced)
© 2014 EduQuest, Inc.
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FDA Seeks Civil Penalties
from California Device Maker
The U.S. Food and Drug Administration (FDA)
announced it is seeking a $2.2 million penalty against
a California device manufacturer for violations of
federal law, including manufacturing standards
violations and the failure to notify the FDA of a
change in an outside supplier or vendor, which may
have exposed recipients of the devices to
unnecessary health risks.
© 2014 EduQuest, Inc.
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FDA Seeks Civil Penalties
from California Device Maker
The alleged GMP violations include the failure to
sufficiently evaluate and select a new vendor as the
supplier of a critical device component and the
failure to adequately validate the continued safety
and effectiveness of the device by testing lots under
actual or simulated use when the unapproved
vendor's component was used
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FDA Warning Issued for Contract
Manufacturer – Related Violations
• An FDA warning letter was issued to a medical
device manufacturer for several problems related to
its use of a contract manufacturer
– The unsigned purchasing procedure, written during the
inspection, does not require an evaluation of potential
suppliers, contractors and consultants
– The firm does not maintain a list of purchasing data or
documents describing product requirements, specifications
and quality expectations for its devices being manufactured
at contract facilities © 2014 EduQuest, Inc.
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FDA Warning Issued for Contract
Manufacturer – Related Violations
– The manufacturer did not document the results of its
evaluation of its contract manufacturing facilities’
ability to meet its requirements
– The firm also did not establish quality-system
procedures outlining the responsibilities and
manufacturing operations for each of its contract
manufacturing facilities before receiving its first
production lot from the manufacturer, packager and
sterilizer
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Janet Woodcock to the US Senate
“All parties throughout the supply chain
from the production of the API and the
ingredients, through brokers, distributors,
importers to finished product manufacturers
must be held responsible,”
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Janet Woodcock to the US Senate
“They (manufacturers) are the ones that must
be held responsible for assuring the quality and
the integrity of the products they produce.
FDA or any other worldwide regulator can not
test quality into products and we can not
inspect quality into products. FDA must have
the tools to hold all these parties accountable.”
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Senator’s Comments
• Companies should be required to know more
about the firms from which they obtain their
ingredients and device components, and audit
them for ongoing compliance. Reputable
companies do so already.
• Manufacturers must also use better tests of their
own to detect nonconformities and contaminants.
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Protecting Both Companies
• Contracts and Service Level Agreements (SLAs)
should include sections on –
– Definitions
– Scope
– Conditions and limitations
– Key contacts (responsibilities)
– Reporting and documentation requirements
– Change management
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Protecting Both Companies
• Contracts and SLAs (cont’d.)
– Property
– Secrecy
– Duration
– Arbitration
– Agreement
– Infrastructure
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Protecting Both Companies
• Contracts and SLAs (cont’d.)
– Service delivery
– Support
– Quality processes
– Management processes
– Regulatory requirements
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Protecting Both Companies
• Contracts and SLAs (cont’d.)
– Validation requirements and expectations
– Delivery of documentation
– Business continuity
– Etc.
© 2014 EduQuest, Inc.
Key Outsourcing Controls
• The outsourcer must have established and clearly
defined:
– Company quality and integrity standards
– Quality policy
– Management responsibilities
– Quality responsibilities
– Vendor and supplier management processes
22 © 2014 EduQuest, Inc.
Potential Outsourcing Partners
• Should have already defined their own quality and
integrity standards and these must be a good “fit” with
the outsourcer
• Must understand and be willing (and able) to fully
comply with the regulatory requirements
• Must understand and recognize their own exposure to
regulatory enforcement risks
23 © 2014 EduQuest, Inc.
Selecting Partners
• Company management (and not just Quality)
must have processes for evaluating and
effectively managing potential partners
– Survey, audit, selection process
– CAPA processes
– Clearly defined regulatory compliance processes
– Clearly defined risk analysis
24 © 2014 EduQuest, Inc.
Selecting Partners
• When is the most effective time to evaluate a
potential outsourcing partner?
– Before a deal is made or a contract is signed
– After that, the attention you get and the
leverage you have can be greatly diminished
25 © 2014 EduQuest, Inc.
A Critical Part of Supply Chain
Management – Handling Nonconformance
• OOS results, recalls, complaints:
– Responsibilities and processes must be
established for handling nonconformance
– Must establish who, how, and when for initial
investigations, root cause analysis, follow-up,
CAPA, etc.
– Issue closure must be clearly defined and
assured 26 © 2014 EduQuest, Inc.
A Critical Part of Supply Chain
Management – Risk Management
• Supplier Management is only a portion of
overall Supply Chain Management
• Regulatory concerns stem from Risk and Risk
Priorities – Patient
– Product
– Process
27 © 2014 EduQuest, Inc.
A Critical Part of Supply Chain
Management – Risk Management
• As we outsource our opportunities to impact
patient, product, and process quality become
fewer and more critical.
• A comprehensive supplier management program
is required by law to protect the contractor.
28 © 2014 EduQuest, Inc.
Supplier Preparation for an FDA Visit
• One of our primary goals is to MANAGE the
inspection from start to finish by:
– Understanding the FDA’s expectations
– Preparing the supplier site
– Generating documented evidence of compliance with
FDA regulations
– Managing the inspection process
– Interacting appropriately with FDA inspectors
© 2014 EduQuest, Inc.
Supplier Preparation for an FDA Visit
• The pre-identified Escort (inspection coordinator)
greets inspectors and brings them to the Audit
Room
• Notification of arrival is communicated to
remaining management and appropriate
individuals (usually best for the receptionist to do
this after the Investigators leave with their Escort)
© 2014 EduQuest, Inc.
Supplier Preparation for an FDA Visit
• Prior to the inspection identify:
– Inspection team
– Subject matter experts – Area experts
– Scribes, escorts and runners
– A system for logging and tracking documents and document requests
– Staging room – (war room)
– A dedicated conference room
• Train all employees especially for the above responsibilities
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© 2014 EduQuest, Inc. 32
Supplier Preparation for an FDA Visit
• Assure that you have policies and procedures
for process development, validation, and
operations
• Assure that procedures are followed
• Assure that the records are kept and
consistent with the procedures
• Assure you and any vendors have a Quality
Assurance Program that is followed
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Supplier Preparation for an FDA Visit
• Know answers to obvious questions
– How are policies and procedures documented and controlled?
– How are records kept?
– What records show policies and procedures were followed?
– Who are the subject matter experts to answer questions?
Supplier Preparation for an FDA Visit
• Have the key documents readily available
• Know what is in the documents
• Maintain up-to-date records
• Maintain validation documentation
• Assure training and training records are up to
date and complete
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Supplier Preparation for an FDA Visit
• Inspectors will request to speak to the individuals
responsible for making decisions
• Subject Matter Experts (SMEs) should…
– Be knowledgeable in product and study(ies) being
inspected
– Answer only questions being asked (but be complete)
– Request support from Escort or additional SME’s as
needed
© 2014 EduQuest, Inc.
Supplier Preparation for an FDA Visit
• Maintain notes of all discussions that take place in
the audit room (scribe notes)
– The Scribe should…
• Keep detailed notes (typed or handwritten)
• Keep the staging room informed of all inspector
requests
• Have a separate person (Runner) performing this task
(or an electronic process for this communication)
© 2014 EduQuest, Inc.
Supplier Preparation for an FDA Visit
• Pre-stage documents that FDA will likely want to
see
– Study records, quality records, manufacturing records,
verification records, etc.
– SOPs and Quality System documents (Management
Controls, CAPA, Complaints, etc.)
• Ensure timely fulfillment of inspector requests or set
expectations for fulfillment
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Auditor’s Rule of Thumb
If it is not documented
It was not done!!!!!
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Purpose of Documents, Records and
Change Controls
• To assure that specifications and procedures are
adequate
• To assure only current documents are used
• To assure maintenance of documents for
required length of time
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Purpose of Documents, Records and
Change Controls
• To assure appropriate review and approval by
responsible personnel
• To assure changes are reviewed, approved and
incorporated into documents by the same
people in the same function or organization
that performed the original review and
approval, unless specifically designated
otherwise
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Elements of Data Quality
• Electronic and paper records must provide the same
degree of confidence and reliability and must be
– Attributable
– Legible
– Contemporaneous
– Original
– Accurate
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Common Outsourcing Pitfalls
• Your partner changes processes, personnel,
locations, ownership, etc., without telling you
• If it’s not in the contract . . .
• The service, system, software, product, etc.,
doesn’t really exist yet
• Your partner has your data . . . now what?
42 © 2014 EduQuest, Inc.
Avoiding the Pitfalls
• Make sure it is in writing (assume nothing!)
• Retain clear leverage (management attention)
• Train them on your requirements, regulatory
requirements, and retrain as necessary
• Diligent audits and rigorous follow-up
• Diligent monitoring – review the data
• Constantly measure compliance
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What Should Not be Outsourced
• Any activities:
– Where your company holds the technical
expertise and does not want to give up control
– That you cannot effectively monitor
– That are related to a specific commitment to
FDA or other government Agencies
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A Few Critical Issues
• There is a need for:
– Strong, inclusive contracts and quality agreements
– Diligent audits
– More diligent monitoring
– Better review of routine data
– Better documentation of actions
– Better training of suppliers on your requirements and regulatory requirements (retrain as necessary)
– Constantly measuring compliance
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A Few Critical Issues
• Maintain a Healthy Relationship
• Monitor and Trend
– Monitor based upon defined processes and defined risk
– Collect key process data on performance (control
points)
– Trend past, current, and plan future performance relative
to expectations and quality goals
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A Few Critical Issues
• Both the Contractor and Supplier must decide
and act based upon:
– Clearly defined roles and responsibilities
– Clearly defined methods for detecting problems
– Clearly defined and well documented CAPA system
• Corrections
• Corrective actions
• Preventive actions
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A Few Critical Issues
• Continuous Improvement
– Actions based upon defined risks
• Reevaluate risks
• Reevaluate processes
– Predefined mitigations
• Measure effectiveness
• Refine mitigations
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Consequences of Non-Compliance
• Possible regulatory enforcement actions
– Disqualification of a nonclinical laboratory
– Clinical hold or termination
– Delay in approval of new products or facilities
– Rejection of application data (e.g., clinical trials)
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Consequences of Non-Compliance
• Possible regulatory enforcement actions
– Disqualification of clinical investigators
– Initiation of the Application Integrity Policy
– Warning Letter (including sanctions)
– Withholding approval of Certificates for
Foreign Government (CFGs) used for exports
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Consequences of Non-Compliance
• Possible regulatory enforcement actions
– Product seizure
– Import restrictions
– Consent Decree
– Criminal prosecution
– Debarment
Summary
• Regulators have and will have an increased focus on
supplier management
• Heightened manufacturer oversight (more regulatory
inspections)
• Better local and national coordination of inspection
strategy
• More international inspections
(Higher Risks)
52 © 2014 EduQuest, Inc.
Q U E S T I O N S ?
Contact: EduQuest, Inc.
1896 Urbana Pike, Suite 14
Hyattstown, MD 20871
+1 (301) 874-6031
www.EduQuest.net
© 2014 EduQuest, Inc. 53