GMP Inspection report - Community format
Inspected site(s):
Name and full address of the Inspected site
Activities Carried out
Manufacture of Active Substance
Manufacture of Finished Medicinal Product
Packaging
Importing
Laboratory Testing
Batch Control and Batch Release
Inspection date(s):
Date(s), month, year
Inspector(s):
Name of the inspector(s),
Name of expert / assessor (if applicable)
Name of the Competent Authority(ies).
References:
Number of Marketing and / or Manufacturing
Authorisations
EMEA reference number(s).( If the inspection is
an EMEA inspection)
Introduction:
Short description of the company and the
activities of the company.
It should be noted if a site master file was
available before the inspection.
Date of the site master file.
For inspections in non-EC/EEA countries it
should be stated whether the Competent Authority
of the country, where the inspection took place,
was informed of the inspection and whether the
Competent Authority took part in the inspection.
Date of previous inspection
Names of Inspectors involved in previous
inspection
Major changes since the previous inspections
should be detailed.
GMP-546-98-v 7-EN.doc
Brief report of the inspection activities
undertaken:
Scope of Inspection:
Short description of the inspection (Product
related inspection and/or General GMP
inspection). The reason for the inspection should
be specified.
Inspected area(s):
Each inspected area should be specified.
Personnel met during the inspection:
The names and titles of key personnel met, should
be specified,( listed in annex)
Inspectors Teams findings and
observations:
Relevant headings from The Rules Governing
Medicinal Products in the European Community,
Good Manufacturing Practice for Medicinal
Products Vol. IV.
New headings may be introduced when relevant.
Headings to be used ( Choose those
headings relevant to the scope of the
Inspection):
Quality Management
Personnel
Premises and Equipment
Documentation
Production
Quality Control
Contract Manufacture and Analysis
Complaints and Product Recall
Self Inspection
Questions from the Assessment of the Application
( Pre- authorisation Inspections)
Investigation of Product Recall or Product Defect
Miscellaneous:
Samples taken
Distribution
Assessment of the Site Master File
Annexes attached:
List of any annexes attached
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Summary of Deficiencies:
The deficiencies should be listed and the relevant
reference to the EU GMP Guide and other
relevant EU Guidelines should be mentioned.
If the deficiencies are related more to the
assessment of the application it should be clearly
stated.
The company should be asked to inform the
Inspectorate about the progress of the corrected
actions and a proposed time schedule for
corrections.
Recommendations
To the Committee requesting the Inspection or to
the Management / Enforcement Authority for the
site inspected
Summary and conclusions:
The Inspection Team should state if the Company
operates in accordance with the EU GMP Rules.
Name(s)
The Inspection Report should be signed and dated
by the Inspector(s)/Assessors having participated
in the Inspection.
Signatures(s)
Organisation(s)
Date:
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Definition of Significant Deficiencies
1. CRITICAL DEFICIENCY: A deficiency which has produced, or leads to a significant risk
of producing either a product which is harmful to the human or veterinary patient or a
product which could result in a harmful residue in a food producing animal.
2. OTHER SIGNIFICANT DEFICIENCY: A non-critical deficiency, which has produced or
may produce a product, which does not comply with its marketing authorisation.
or
which indicates a significant deviation from EU Good Manufacturing Practice.
or
(within EU) which indicates a significant deviation from the terms of the manufacturing
authorisation.
or which indicates a failure to carry out satisfactory procedures for release of batches or
(within EU)
a failure of the Qualified Person to fulfil his legal duties.
Note: Several smaller related deficiencies, none of which on their own may be significant,
may together represent a significant deficiency and should be reported as such
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