Heads of Medicines Agencies

European Medicines Agency Inspections

GMP Inspection Services Group
Joint Audit Programme for EEA GMP Inspectorates

London, 8 August 2006

Doc. Ref. EMEA/INS/GMP/313392/2006

JOINT AUDIT PROGRAMME FOR EEA GMP

INSPECTORATES

Observed Inspection Checklist

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95
E-mail: gmp@emea.europa.eu http://www.emea.europa.eu
Public
EMEA 2007 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged

Joint Audit Programme for EEA GMP Inspectorates

Observed Inspection Checklist

Auditee.....................................................................
Inspected Company..................................................
Date..........................................................................

OBSERVED INSPECTION FORM

Number
Criterion
1
Inspectors skills match with required skills (especially general
inspections methodology and knowledge of manufacturing operations of
the site to be inspected)
2
Criteria for notification of inspections are met
3

An inspection plan is developed prior to commencement of the inspection

The focus of the inspection plan is based on the GMP compliance history
of the establishment
Requirements as detailed in the procedure for pre inspection preparation
are met
Inspection methodology as described in the inspection procedure are
followed
The different stages as described in the inspection procedure are followed

5
6
7
8
9

The inspection plan is adjusted, where warranted, based on inspection

findings
Observations are based on GMP requirements

10

Observations are factual

11

Inspection reports are completed in the required reporting format

JAP Observed Inspection Checklist

Comment/Observation

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Joint Audit Programme for EEA GMP Inspectorates

OBSERVED INSPECTION FORM

Number

Criterion

Comment/Observation

12

Assessment of the company's overall compliance rating is reasonable

with respect to the inspection carried out

13

An up-to-date manual or electronic database of inspections is maintained

14

The integrity and confidentiality of inspection data is controlled

15

Post inspection activities, as described in procedure, are adequate: this

can be checked with a retrospective study based on a previous inspection
The auditee inspector is consistent in his approach

16
17

GMP inspection covers the companys manufacturing operations as

described in the manufacturing authorisation

JAP Observed Inspection Checklist

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