MHRA GDP Symposium. Novotel London West, London 8 & 10 December #GMDPevents

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1 MHRA GDP Symposium Novotel London West, London 8 & 10 December 2015

2 Complex Business Models - Outsourced Activities Presented by: Jacqueline Masayi, GDP Inspector

3 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 3

4 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 4

5 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 5

6 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 8

7 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? 9

8 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 Key elements of a written contract Correctly defined Suitable v generic Clear, unambiguous language, free from errors Subject to regular review Quality and integrity of medicinal products maintained throughout the supply chain Agreed & signed by both parties 10

9 Written Contracts (sample) 11

10 Written Contracts (sample) 12

11 Written Contracts (sample) 13

12 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 14

13 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 15

14 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 16

15 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. 17

16 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 18

17 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. 19

18 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 20

19 Final thought Outsourcing 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 21

20 THANK YOU! 22

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