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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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