Post on 04-Jun-2018
transcript
GDP Audits : Weak points when conducting GDP Audit based on inspectionss
COOL SUPPLY System & Solutions 2017
Webinar 15 February 2017
Riekert Bruinink
Dutch Healthcare Inspectorate
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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
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1. Introduction EU GDP Guidelines
• Publication new EU GDP guide: 7th March 2013
• Implementation period : 6 months (until 8 September 2013)
• Publication new version EU GDP
Guidelines 23-11-2013
( corrections text and translation errors)
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?
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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
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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)
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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
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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.
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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
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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)
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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
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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)
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.
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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
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2. Riskanalyses
•Chapter 1 : Risk analysis procedure and analysis of most
important risks ;planned measures to reduce risks
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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
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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
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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
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2. Temperature management storage area
• Chapter 3 : monitoring, registration and control temperaturestorage area; alarm and follow-up ; mapping
during summer and winter
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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.
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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.
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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 !
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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
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2. Self-inspections
• Chapter 8 : Self-inspections should be planned and
performed periodically; SOP
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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
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2. Transportation
* Chapter 9 : Transportation outsourced ,audits performed and
contracts (QA,TA) available.
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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.
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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 !
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