New GDP Guidelines - Implementation

Transcription

1 New GDP Guidelines - Implementation Alfred Hunt, Inspector Wholesale Distribution Conference 11 th November 2014

2 New GDP Guidelines 2013/C 63/01-8 th September /C 343/01-5 th November

3 Words 7983 Words 3

4 Quality System Updates Change Control Deviation Management Risk Assessment Management Review 4

5 Management Review Must review QMS routinely and document findings Assess performance (complaints, deviations, CAPA, change control, risk assessments, inspections, outsourced activities) Emerging regulations, guidance and quality issues Innovations Changes in business environment SOP / Form Minutes (Relevant) Communicated internally 5

6 Qualification & Validation Qualification Action of proving that any equipment works correctly and actually leads to the expected results. Validation Action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results 6

7 Qualification & Validation Did we design the system correctly? How confident are we that the system operates as intended (repeatable, accurate, effective)? How can we demonstrate this? When should we repeat a validation exercise? 7

8 Validation & Qualification Validate processes Identify key processes Risk assess critical steps Challenge the system worst case scenarios Document Qualify equipment Identify key pieces of equipment Do they operate correctly? Do they operate as intended? Are the results they provide accurate, repeatable? Challenge with max/min loads, users etc. 8

9 Maintenance of Critical Equipment Identify critical equipment SLAs with service providers Documentation Risk assessment frequency, effort Unplanned / Planned Challenge alarms (& document) 9

10 Temperature Management of Small Areas New GDPs allow for RA of small areas without temperature mapping If no mapping is justified then must have a risk assessment performed. 10

11 Outsourced Activities Identify & document outsourced activities (storage, transport, calibration, pest control, RP) Audit? Oversight Contract WDA for separate premises 11

12 Qualification of Suppliers Due Diligence Checks Reputation & reliability of supplier Offers of products more likely to be falsified Out of-range prices Large quantities of products usually not available Use Independent verification where available Paperwork without all required details Professionalism, business sense, knowledge of products Is all documentation forthcoming (WDA, GDPc) Falsified Medicinal Product False Representation of: -Identity (Packaging/Labelling/Name/Composition) -Source (Manufacturer / Country / MAH) -History (Records/Documents/Distribution Channel) 12

13 Qualification of Suppliers Due Diligence Checks Website, references All details correlate Look at delivery documentation, labelling EudraGMDP, GDP Certificates, Non-Compliance Statements Are brokers used? Comply with Ch.10 Periodic re-assessment 13

14 Returns Considered a return if has left the premises Non-WDA/MIA holders accept only if returned within 10 Days of receipt by the customer Exceptions: Deviation, risk assessment, separately maintained documentation, fully justified, RP approval of deviation 14

15 Safety Features Aim is to prevent falsification of product Final provisions to be published end 2014 Safety features to be introduced by D barcode Unique pack identifiers Tamper evidence measures POM only (with exceptions) Repositories verification and check out 15

16 Batch Tracking Batch tracking will be required for products with safety features Goods In Goods Out Returns (Quarantine/Reject/Disposal) Products brokered Manual or automated systems Included on delivery documentation 16

17 Other Items Ongoing competence of RPs Role profiles for personnel in key positions (role, responsibilities, deputisation) Control Reports Transportation Risk assessment Brokers 17

18 Other Items Segregation of Items not suitable for sale Management Ensuring adequate resources are made available 18

19 European Commission Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01) HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use (IA-G0046-2) 19

20 Thank you