Application for a Certificate of Good Manufacturing
Practice of a Manufacturer (Active Substance)
1
APPLICANT DETAILS
Name of applicant:
Company name:
Company address:
Company Registration Office number (CRO):
Telephone/fax number of contact:
E-mail address of contact:
2
CERTIFICATE DETAILS: SITE
(Please state the full name and address of site of manufacture.)
Name of manufacturer:
Site address:
DUNS number (if available):
Inspection reference number - HPRA ref. (if available):
Dates of inspection (if available):
3
CERTIFICATE DETAILS: NAMES OF ACTIVE SUBSTANCES
Please print names clearly (in the spaces provided for sections A, B, C, D) as they should
appear on the certificate. Where certification applies to an active substance intermediate, the
chemical name of the intermediate should be included. The activities carried out in relation to
each active substance should be identified from the following list.
Where the only types of activities carried out in relation to active substance are those listed
under sections E, F or G then it is not necessary to add the individual names of the active
substances.
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A
Manufacture of Active Substance by Chemical Synthesis
1
Manufacture of active substance intermediates
<Name of active substance(s)>
Manufacture of crude active substance
<Name of active substance(s)>
Salt formation/Purification steps (e.g. crystallisation
<Name of active substance(s)>
Other
<Name of active substance(s)>
2
3
4
B
Extraction of Active Substance from Natural Sources
1
Extraction of substance from plant source
<Name of active substance(s)>
Extraction of substance from animal source
<Name of active substance(s)>
Extraction of substance from human source
<Name of active substance(s)>
Extraction of substance from mineral source
<Name of active substance(s)>
Modification of extracted substance
<specify source from which the substance is extracted (1,2,3,4) after the substance
name>
Purification of extracted substance
<specify source from which the substance is extracted (1,2,3,4) after the substance
name>
Other
<Name of active substance(s)>
2
3
4
5
6
7
C
Manufacture of active substance using Biological Processes
1
Fermentation
<Name of active substance(s)>
Cell Culture (e.g. mammalian/bacterial)
<where relevant, specify cell type for each substance named>
Isolation/Purification
<Name of active substance(s)>
Modification
<Name of active substance(s)>
Other
<Name of active substance(s)>
2
3
4
5
D
Manufacture of sterile active substance (note Parts A,B & C to be completed as
applicable)
1
Aseptically prepared
<Name of active substance(s)>
Terminally sterilised
<Name of active substance(s)>
2
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E
General Finishing Steps
1
Physical processing steps (e.g. drying, milling/micronisation, sieving.)
2
Primary Packaging (enclosing/sealing the active substance within a packaging material
which is in direct contact with the substance)
3
Secondary Packaging (placing the sealed primary package within an outer packaging
material or container. This also includes any labelling of the material which could be
used for identification or traceability (lot numbering) of the active substance)
4
Other (for operations not described above)
F
Quality Control Testing
1
Physical/Chemical testing
2
Microbiological testing (excluding sterility testing)
3
Microbiological testing (including sterility testing)
4
Biological testing
G
Other activities relating to active substances
1
Importation (Importation of active substance from a country which is outside the EEA)
2
Distribution
3
Other
4
<specify>
<specify>
<specify>
DECLARATION
I hereby declare that the above particulars are, to the best of my belief, correct.
Signing on behalf of the Applicant
Signature: _______________________________
Date:
Print name:
Position/title:
Signing on behalf of the Manufacturer (if different)
Signature: _______________________________
Date:
Print name:
Position/title:
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FOR OFFICE USE ONLY
Application logged by:
Certificate prepared by:
Certificate approved by:
Certificate number(s):
HPRA reference number(s):
Certificate sent to applicant (sign and date):
Send to:
Inspections Section,
Compliance Department,
Health Products Regulatory Authority,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2.
Tel:
+ 353 1 676 4971
Fax:
+ 353 1 676 7836
E-mail: inspect@hpra.ie
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