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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

Titel van presentatie | datum van presentatie2

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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?


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


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)


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


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.



• 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



• 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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• 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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• 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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• 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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• 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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• 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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• 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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