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MHRA GDP SymposiumNovotel London West, London
8 & 10 December 2015
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Complex Business Models -Outsourced ActivitiesPresented by: Jacqueline Masayi, GDP Inspector
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Background
Increased complexities of the supply chain
Virtual Operators
Falsified Medicines Directive
– requiring greater traceability
Safe and secure supply chain
• Legal obligation to ensure licensing requirements are met
• Regulatory obligation to comply with requirements of GDP
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Legal Obligation
Human Medicines Regulations 2012, Reg. 18
“Distribution of a medicinal product by way of wholesale
dealing, or possession for the purpose of such distribution..”
• HMR 2012 distributing = a) selling or supplying b) procuring
or holding or exporting
Licensing requirement
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Regulatory Obligation
• Any GDP activity that is outsourced should be correctly defined,
agreed, controlled and there must be a written contract between
the contract giver and contract a acceptor which clearly
establishes the duties of each party
EU Guidelines on GDP, Chapter 7
Outsourced Activities
• The quality system should extend to the control and review of
any outsourced activity
EU Guideline on GDP 1.3
Management of Outsourced Activities
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Examples of contracting in the GDP environment
• Virtual Operators e.g. MAHs, Mainliners,
Shortliners, Small to Medium wholesalers
• Specials Manufacturers (contract man.)
• Procurement
• Logistics providers – Storage and Transport
• Contract RPs
• Regulatory services
• Pharmacy Groups
• IT services
• Hospitals – NHS & Private
• Freight forwarders/Exporters
• Temperature Mapping
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Any UK site performing any of the following activities on behalf
of the licence holder must be specified on the WDA(H)
Procurement
Holding:
- sites holding ambient products in excess of 36
hours must be licensed.
- sites where refrigerated products are held, even when
this is for less than 36 hours, must be licensed.
Supply
Export Is contract Acceptor
appropriately licensed to
perform the outsourced
activity on my behalf ?
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Written Contracts
For any activity covered by the
GDP Guide that is outsourced:
• There must be a written contract
between the contract giver and
contract acceptor which clearly
establishes the duties of each
party
Quality and integrity of medicinal
products maintained throughout the
supply chain
Key elements of a written
contract
• Correctly defined
• Suitable v generic
• Clear, unambiguous
language, free from errors
• Subject to regular review
• Agreed & signed by both
parties
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Written Contracts (sample)
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Written Contracts (sample)
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Written Contracts (sample)
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What could go wrong ? Case Study 1
No contract in place
No evaluation prior to activity
• Location from which wholesale activities were performed was not
licensed
• Misunderstandings e.g. Temperature deviation: no
communication process, no investigations and no action plan
- Quality of products compromised
- Recall
- Regulatory action taken
- Reputational damage
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Case Study 2
Contract not correct and suitable
Named RP was acting for storage and distribution site only
• The procurement activity was overlooked
- Medicines were purchased from a company that did not
hold the appropriate authorisation
- Legal action
- Regulatory action
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Case Study 3
Contract Giver or Contract Acceptor?
Activities and responsibilities not correctly defined
• Outsourced activities were not adequately controlled
– Duties of each party not clearly established
– All activities not covered in the written contract
– Work passed to third party of contract acceptor without
knowledge of contract giver
– Major deficiency
– Frequent inspections
– Risk profile affected
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Risk Mitigation Strategies…
• Is the company authorised to perform the activity?
– Check authorisation status ( authorised wholesale
operations, site details)
– Due diligence check – EUDRA non compliance
statements
• Is there a Written Contract in place?
• Regular review and communication of any changes
appropriately to all Contract Givers.
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Risk Mitigation Strategies…cont.
• Are outsourced activities controlled and reviewed within
quality system?
- Suitability and competence of contract acceptor
assessed prior to activity being carried out?
- Frequent audits based on risk
- Responsibilities and communication processes
defined
- Performance monitoring and review to identify
and implement required improvements on a regular
basis
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Risk Mitigation Strategies…cont.
• The written contract should require the Contract Acceptor to
forward any information that can influence the quality of the
products to the Contract Giver
e.g.
• Temperature deviation during transportation should be
reported to the wholesale distributor and recipient of the
affected products
• Changes – premises, key personnel
• Work entrusted to the Contract Acceptor should not be
passed to a 3rd party without prior approval and evaluation
by the Contract Giver.
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Why is this important?
• Compliance
– Legal and Regulatory
• Patient Safety
– Maintaining the quality and integrity of products
– Proper distribution of medicinal products; procured, held,
supplied and exported in a way that is compliant with
GDP)
• Business
– Cost effective
– Expertise in area
– Reputation
– Customers
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Final thoughtOutsourcing of GDP activities is becoming increasingly complex
Contract Giver – Responsible for the activities contracted
out.
• The quality system should extend to control and review of any
outsourced activities
Contract Acceptor – Licensing and GDP requirements apply
to outsourced activities
• Work ordered by Contract Giver must be carried out in
accordance with the specific product requirements
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THANK YOU!
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