Feedback from Inspection Programme
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1 Feedback from Inspection Programme Wholesale Distribution Conference 8 th February 2017 Darren Scully Health Products Distribution Manager
2
3 Wholesale distribution overview wholesale distribution procure hold supply export quality system Directive 2001/83/EC, Article 1(17) Medicinal Products (Control of Wholesale Distribution) Regulations 2007, Schedule 2, paragraph 5A
4 Wholesale distribution overview return/recall storage receipt pick & pack transport delivered quarantine destruction
5 Wholesale distribution overview investigation CAPA deviation deviation process start process end planned change risk management
6 Wholesale distribution overview
7 Wholesale distribution overview investigation CAPA deviation deviation process start process end risk management
8 Inspection programme risk-based inspection planning New application Full GDP inspection (12-18 months) Full GDP inspection (risk assess) Full GDP inspection risk assess
9 Inspection programme risk-based inspection planning
10 method Target range of companies and products small large medium routine inspection only
11 findings Top 5 areas 2014 Top 5 areas 2017 Chapter 5 Operations Chapter 3 Premises & Equipment Chapter 3 Premises & Equipment Chapter 1 Quality Management Chapter 6 Chapter 1 Chapter 2 Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls Quality Management Personnel Chapter 9 Chapter 5 Chapter 6 Transport Operations Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
12 chapter 3 premises & equipment practical aspects issues - temperature - segregation - risk-based probe location - handling of excursions - calibration
13 chapter 3 premises & equipment practical aspects - temperature - segregation issues - pending decision (physical or electronic) - not intended for patients (physical)
14 chapter 1 quality management practical aspects issues - deviation documentation - CAPAs & effectiveness - management involvement - investigation - risk management - outcome
15 chapter 1 quality management practical aspects issues - deviation documentation - CAPAs & effectiveness - management involvement - root-cause - correct & prevent
16 chapter 1 quality management practical aspects issues - deviation documentation - CAPAs & effectiveness - management involvement - formal process - effectiveness review
17 chapter 9 transport practical aspects issues - validation - technical agreements - route - temperature management
18 chapter 9 transport practical aspects issues - validation - technical agreements - responsibility - audit
19 chapter 5 - operations practical aspects issues - customer approval - supplier approval - traceability - pharmacy - practitioner - WDA holder
20 chapter 5 - operations practical aspects issues - customer approval - supplier approval - traceability - EEA WDA holder - category of product - periodic checks
21 chapter 5 - operations practical aspects issues - customer approval - supplier approval - traceability - reconciliation - expiry
22 chapter 6 complaints, returns, falsified & recalls practical aspects issues - complaints - returns - recalls - product Vs distribution - investigation - trends
23 chapter 6 complaints, returns, falsified & recalls practical aspects issues - complaints - returns - recalls - disposition justification - falsified medicine?
24 chapter 6 complaints, returns, falsified & recalls practical aspects issues - complaints - returns - recalls - identification of customer - decision to recall
25 Wholesale distribution overview
26 Feedback from Inspection Programme text questions to:
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