Risk Assessment of Outsourcing Pharmaceutical Packaging

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1 Risk Assessment of Outsourcing Pharmaceutical Packaging Dr Afshin Hosseiny November 2004 Slide Number 1 11/04

2 Why Outsource? Technical requirements Capacity requirements Speed of Setting up Location - market requirements Costs! Slide Number 2 11/04

3 What to Outsource? Primary packaging operations Secondary packaging operations Primary & secondary packaging May include pack design artwork sourcing of materials Slide Number 3 11/04

4 How to Outsource Assess internal (own) resources personnel facility equipment capacity Assess external resource availability personnel facility equipment capacity Slide Number 4 11/04

5 How to Outsource Assess ability to manage contractors technical support product/technology transfer auditing & monitoring Consider associated risks doing it in-house Vs outsourcing Slide Number 5 11/04

6 What should be considered? technical knowledge requirements product(s) characteristics facility & equipment cgmp - ability to comply! location - logistics considerations capacity - availability personnel requirements regulatory requirements Slide Number 6 11/04

7 What should be considered? assess internal resources do we have suitable facility/equipment? do we have sufficient capacity? people facility & equipment infrastructure, e.g.qc/qa, warehouse, etc. do we have technical expertise? any limitations,e.g. regulatory, market,etc. costs! Slide Number 7 11/04

8 What should be considered? assess external resources, can you find a company with required: technical expertise capacity - facility & equipment resources - people, infrastructure are they located where you want them? regulatory consideration local market considerations costs! Slide Number 8 11/04

9 Risk Assessment Risks - in-house! insufficient knowledge (technology!) poor /lack of local market requirements insufficient capacity may require capital investments costs lead time, design, build, install, validate overall unit cost may be too high! Slide Number 9 11/04

10 Risk Assessment Advantages - in-house under own control can implement operations in line with own policies and procedures limited management issues staff development Slide Number 10 11/04

11 Risk Assessment Risks - outsourcing confidentiality issues technical knowledge resource availability capacity - (in line with your timelines!) other products in the facility other customers! communication & management issues Slide Number 11 11/04

12 Risk Assessment Advantages - outsourcing technical knowledge for specialist products local market advantages, e.g regulatory resource availability logistical advantages (e.g. close to market or region) potentially lower costs! Slide Number 12 11/04

13 Developing Requirements What is it you want to outsource? Primary packaging secondary packaging both sourcing of materials what standards do you expect? regulatory local market own company Slide Number 13 11/04

14 Developing Requirements Document your expectations on quality standards volumes/spread over say 12 months regions to be covered stock control support availability, tech transfer, validation audits right to visit dealing with complaints Slide Number 14 11/04

15 High = must have Developing Requirements (Setting priorities) meeting cgmp standards validation regulatory approval capacity cost?!! Slide Number 15 11/04

16 Developing Requirements (Setting priorities) Medium = would like to have but will accept alternatives sourcing materials from your approved suppliers use of dedicated facilities stock holding Low = nice to have Slide Number 16 11/04

17 Decision Making Assess risk, considering requirements in-house advantages in-house disadvantages outsource advantages outsourcing disadvantages priorities First level decision Slide Number 17 11/04

18 Decision Making If decision was to outsource, then; identify potential candidates conduct due diligence audits prepare short list second risk assessment use knowledge from audits assess against the requirements and priorities Slide Number 18 11/04

19 Risk Management detailed contract with the contractor business quality & technical prepare technical transfer documentation provide technical support (product data) agree roles & responsibilities prepare mitigation plans for each risk monitor progress, including the first launch Slide Number 19 11/04

20 Summary outsourcing packaging can be a good short or long term solution ensure you know and have documented your requirements have a robust selection process always challenge against in-house option must have sufficient resource to transfer technical knowledge, implement & validate Slide Number 20 11/04

21 Summary must have sufficient resource to continue support, monitor and audit a good detailed technical agreement will minimise problems if cost is the main driver, then ensure you include cost of technical transfer and support required! Slide Number 21 11/04

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