Doc Ref CMDh/362/2010/Rev2 July 2019 Active Substance Master File

doc. ref: cmdh/362/2010/rev.2 july 2019 active substance master file (asmf) assessment report restricted part nb: this repor

Doc. Ref: CMDh/362/2010/Rev.2
July 2019
Active Substance Master File (ASMF)
Assessment Report
Restricted Part
NB: THIS REPORT SHOULD NOT BE DISCLOSED TO THE APPLICANT
<(Active Substance)>
<(ASM)>


ASMF number as allocated by NCA (if available):
ASM’s Internal API code
(if applicable):

ASMF holder



ASM’s manufacturing site(s):



Brief description of manufacturing steps performed by manufacturing
site (if more than one site/if applicable):
Assessor/s:
Name  
Tel:  
Email:  
Date of ASMF Assessment Report:
Assessment report:
Assessment of responses: N/A or date of respective AR
Assessment of responses for outstanding questions : N/A or date of
respective AR
Letters of Access in relation to specific drug products are described
in the < Variation Assessment report> for
the product in question.
The following information should be provided regarding the medicinal
product for which the ASMF has been submitted:
Maximum daily dose(< 1 gram, < 10 grams, others specified)*
e.g. < 1 gram, < 10 gram, others specified
*Reference source if other than the MRP/DCP application
Route(s) of administration.
Target/patient groups
Neonates/infants/children, adults
Assessment Report on the Restricted Part of the ASMF
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Assessment Report on the Restricted Part of the ASMF 3
S.2 Manufacture 4
S.3 CHARACTERISATION 5
S.4 CONTROL OF DRUG SUBSTANCE 5
conclusion 5
the rms> 6
assessment of responses to the list of questions on the restricted
part of the asmf 7
proposed by the rms> 8
assessment of responses to the list of outstanding questions on the
restricted part of the asmf 9
rms’ overall conclusions on the restricted part of the asmf 9
proposed by the rms> 10
This Assessment Report solely concerns the ASMF. It should however
always be read in conjunction with the assessment report(s) of the
Application for the medicinal product for
which it is associated with.
An ASMF in CTD-format has been provided by ASMF holder for the 
active substance:
Applicant’s Part version:
Restricted Part version:
Please make sure that in this assessment report no reference is made
to the related Drug Product / Variation application and/or medicinal
product for which this ASMF is associated with (e.g. no information on
QP-declaration, procedure numbers). This is important to be able to
re-use the assessment report for other products as well.
In case of updates to an already submitted ASMF, the Table of Changes
between different versions of the ASMF should be included. A
cross-reference to the Table of Changes submitted by the ASMF holder
as a separate document to the main Submission Letter and included by
the assessor as an Annex to the ASMF Assessment report is also
acceptable.
The structure of the report should reflect the relevant parts of
Module 3.2.S
S.2 Manufacture
S.2.1 Manufacturer of the active substance (name, address and
responsibility of each party, including contractors/intermediate(s)
manufacturer(s) involved in the manufacturing chain)
Manufacturing site
Responsibility
S.2.2 Description of the Manufacturing Process and Process Controls
(detailed information)
S.2.3 Control of Materials
S.2.4 Control of Critical Steps and Intermediates
S.2.5 Process Validation and/or Evaluation
S.2.6 Manufacturing Process Development
RMS’s comments on S.2 Manufacture:
S.3 CHARACTERISATION
S.3.2 Impurities
If applicable according to NfG on ASMF
RMS’s comments on S.3 Characterisation:
S.4 CONTROL OF DRUG SUBSTANCE
S.4.5 Justification of Specification
If applicable according to NfG on ASMF
RMS’s comments on S.4 Control of Drug Substance:
conclusion
----------
the rms>
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:
:
assessment of responses to the list of questions on the restricted
part of the asmf
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Question
Summary of the Applicant’s response
Assessment of the Applicant’s response

Question
Summary of the Applicant’s response
Assessment of the Applicant’s response
rms’ overall conclusions on the restricted part of the asmf
proposed by the rms>
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:
:
assessment of responses to the list of outstanding questions on the
restricted part of the asmf
-------------------------------------------------------------------

Question
Summary of the Applicant’s response
Assessment of the Applicant’s response

Question
Summary of the Applicant’s response
Assessment of the Applicant’s response
rms’ overall conclusions on the restricted part of the asmf
-----------------------------------------------------------
proposed by the rms>
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:
:
ASMF Active Substance 10/10 ASM