GDP Audits : Weak points when conducting GDP Audit based on inspections

Transcription

1 GDP Audits : Weak points when conducting GDP Audit based on inspections s COOL SUPPLY System & Solutions 2017 Webinar 15 February 2017 Riekert Bruinink Dutch Healthcare Inspectorate

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3 AGENDA 1. GDP inspection practice 2. Review of GDP and GDP/GMP inspections - Quality management issues - Responsible Person /training - Temperature management storage / returns - Qualification / outsourcing / transportation 3

4 1. Introduction EU GDP Guidelines Publication new EU GDP guide: 7 th March 2013 Implementation period : 6 months (until 8 September 2013) Publication new version EU GDP Guidelines ( corrections text and translation errors) 4

5 1.GDP Inspection process in general Frequency of GDP inspections Planning (can be risk based) How many and which topics are inspected? It isn t possible to inspect everything Announced / unannounced inspections How long? How many inspectors? 5 Titel van presentatie datum van presentatie

6 1. GDP Inspection process Announcement inspection by a letter Confirmation Request for some documents (SMF/ QMS/Products) inspection - introduction - developments / changes since last inspection - organization / position RP - follow-up previous inspection 6 Titel van presentatie datum van presentatie

7 1. GDP inspection process making programme walking around : inspecting facilities (e.g. entrance, routing of goods, receive,storage /temperature / dispatch ) verification registrations / documents summing up ( critical /major /minor deficiencies) 7 Titel van presentatie datum van presentatie

8 1. GDP inspection process Inspection report Reply of the company with planned/ performed corrections Documented reply for the major remarks Review by the inspector(s) Closing inspection 8 Titel van presentatie datum van presentatie

9 1. Results of an GDP inspection Critical deficiency : significant departure/ risk for the patient Major deficiency : which indicates a (system)failure to carry out satisfactory procedures a combination of several other deficiencies, Minor deficiency : A deficiency, which cannot be classified as either critical or major, but which indicates a departure from GDP. 9 Titel van presentatie datum van presentatie

10 1. Results of an GDP inspection Not compliant with GDP - Critical shortcoming - Majors remarks (4>) - Warning letter / Stop activities? - Re inspection within a year Compliant with GDP after a positive PVA - less then 3/4 majors Compliant with GDP - zero remarks / minor shortcomings 10 Titel van presentatie datum van presentatie

11 1. Results of an GDP inspection GDP certificate after each positive GDP inspection of a wholesaler Given by Healthcare Authorities There are other GDP Certificates (commercial) 11

12 2. Results of GDP inspections Method 35 inspections during the first 6 months of 2014 what kind of companies? - wholesalers with full assortment - parallel wholesalers - logistic providers with warehousing - pharmaceutical wholesalers / exporters - manufacturers with wholesale activities 12

13 2. Results of 35 GDP inspections / topics Quality Management issues (1) Training / Responsible Person (2) Temperature management storage (3) Qualification suppliers / customers (5) Returns / Outsourcing (6/7) Self-inspection system (8) Transportation issues (9) 13

14 2. Management review Chapter 1 : A management review should be made based on analyses of the Quality registrations ; discussion with the management and proposal improvements. 14

15 2. Results of GDP inspections Results : Management review available : 58 %. SOP management review : 52 % Remarks : Management not always involved Not all quality information used Follow up improvements 15

16 2. Riskanalyses Chapter 1 : Risk analysis procedure and analysis of most important risks ;planned measures to reduce risks 16

17 2. Results of GDP inspections Results : Risk analyses performed : 48 % SOP risk analyses : 40 % Unknown : 10 % Remarks First risk analyses,not always based on method Discussion in team 17

18 2. Personnel,training, Responsibel Person Chapter 2 : GDP System for planning and registration GDP training for all involved personnel; training based on new GDP Guidelines; job description RP 18

19 2. Results of GDP inspections Results : System for GDP training : 81 %. Training new GDP Guideline : 54 % Description tasks RP : 69 % Remarks : 30 % of the RP s didn t follow new GDP training Some companies had planned new GDP training 19

20 2. Temperature management storage area Chapter 3 : monitoring, registration and control temperature storage area; alarm and follow-up ; mapping during summer and winter 20

21 2. Results of GDP inspections Results : Monitoring, registration, control : 94 %. Weak system : 18% Temperature mapping : 62 % Temperature mapping (S and W) : 27% Alarm system : 65 % Follow-up alarm :50 % Remarks : Sometimes only one device Sometimes temperature excursions without actions ; alarms on temperature monitoring device. 21

22 2. Qualification of suppliers (customers) Chapter 5 : Qualification of suppliers /customers based on authorization and other items ( i.e.questionnaire about quality status ) SOP should been in place. 22

23 2. Results of GDP inspections Results : Based on authorization : 97 %. Remarks : 35 % Based on questionnaire : 24 % Remarks : Licenses not always controlled and up to date Delivering to unauthorized clients 2 times. Check your performance yearly! 23

24 2. Results of GDP inspections Chapter 6 : System for handling and judging returned goods ; SOP available; based on new GDP Guidelines Results : System available /SOP : 90 %. Based on new GDP Guideline : 20 % Remarks : Responsible Person not always involved Criteria GDP Guideline not followed 24

25 2. Self-inspections Chapter 8 : Self-inspections should be planned and performed periodically; SOP 25

26 2. Results of GDP inspections (Self-inspections) Results : Operational system : 72 %. SOP : 90 % Follow up : 45% Remarks : Sometimes frequency too low. Don t forget QA. External audits are not the same Follow up by CAPA s 26

27 2. Transportation * Chapter 9 : Transportation outsourced,audits performed and contracts (QA,TA) available. 27

28 2. Results of GDP inspections (transportation) Results : Transportation outsourced : 77 %. Contracts available : 84 % Audits performed : 64 % Remarks : Use of sub-contracters with permission. Contracts not always based on new GDP Guideline Not always enough GDP appointments. 28

29 2. Finally The results of the first GDP inspections are reasonable Around 20 % was not compliant Weak points are : - Management review / risk analyses ( around 50%) - Handling returned goods - Qualification suppliers based on quality information. - Temperature mapping storage area - Follow up alarms, temperature excursions selfispections - Temperature mapping There is space for improvement! 29

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