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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