19 February 2019

EMA/544128/2018EMA/544128/2018 – Rev. 1
Committees and Inspections

Joint Audit Programme for EEA GMP inspectorates

JAP Audit plan

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
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© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
 AUDIT PLAN

Auditee:

<abbreviation auditee> - <country>

Audit dates: Lead auditor: Audit team members:

<date from to> <name, NCA> <name, NCA>

Auditee management names:

Auditee contact person(s):

1. Audit scope
 Initial audit (full scope)(reduced scope)

 Re-audit (full scope)(reduced scope)

 Observed inspections

2. Timetable for audit

Day Time Description Attendees

Day 0 Audit team preparation meeting Audit team

<date>

Day 1 Opening meeting at auditee Audit team + auditee

<date> Discussion and acceptance of audit plan

Presentation by auditee

Review selected documents, interviews with relevant Audit team +

staff (15’ maximum per staff member, related to appointed staff
selected process/products)

Observation of preparation for inspection Auditor(s) and

auditee's inspector(s)

Lunch break

Continuation of audit Audit team +

appointed staff

Departure to inspection site Auditor(s) and

auditee's inspector(s)

Audit team debriefing Audit team

Joint Audit Programme for EEA GMP inspectoratesJoint Audit Programme for EEA
GMP inspectorates
EMA/544128/2018EMA/544128/2018 Page 2/4
 First day closing meeting (if wished by auditee) Audit team + auditee

Day 2 etc Audit team briefing Audit team

<date>

Continuation of audit Audit team +

appointed staff

Opening meeting at company by auditee's Auditor(s) and

inspector(s) auditee's inspector(s)

Inspection by auditee's inspector(s)

Lunch break

Continuation of audit Audit team +

appointed staff

Continuation of inspection by auditee's inspector(s) Auditor(s) and

auditee's inspector(s)

Closing meeting at company by auditee's inspector(s) Auditor(s) and

auditee's inspector(s)

Inspection debriefing meeting Auditor(s) and

auditee's inspector(s)

Audit team debriefing Audit team

Day closing meeting (if wished by auditee) Audit team +

appointed staff

Last day Audit team briefing Audit team

<date>

Continuation of audit Audit team +

appointed staff

Lunch break

Continuation of audit Audit team +

appointed staff

Audit team debriefing meeting, preparation of Audit team

observations and opportunities for improvement

Closing meeting at auditee Audit team + auditee

3. Documents
Legislation

Joint Audit Programme for EEA GMP inspectoratesJoint Audit Programme for EEA
GMP inspectorates
EMA/544128/2018EMA/544128/2018 Page 3/4
 Guidelines and
position papers

Internal
documents

Resource allocation

Additional
documents (drafts
included)

Joint Audit Programme for EEA GMP inspectoratesJoint Audit Programme for EEA
GMP inspectorates
EMA/544128/2018EMA/544128/2018 Page 4/4