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GMP REVIEW
AL
TE R N A TI O N
OF
G MP T RAIN March 2004
Issue III
IN
E IN
TH G
INTERNATIONAL
n A new annex on the conduct of inspections of the man-
ufacture of investigational medicinal products (IMPs)
These changes appear to result from harmonisation acti- DEVELOPMENTS
vities within the EU and the implementation of the Clinical
Trials Directive on May 1st 2004.
You can access this document by clicking on:
II. MRA
Revised Compilation of Inspection Procedures*
II.A. Mutual Recognition Agreements (EC-
I.B. Note for Guidance on Plastic Primary Japan
Packaging Materials The EC and Japan have re-confirmed the equivalence and
A revised version of this Guideline was issued recently for implementation of the GMP requirements in accordance
consultation. The closing date for comments (to the EMEA) with the EC-Japan MRA.
is August 31st 2004.
Agreement was also reached on the procedures required
If you are interested you can see a copy of the draft NFG for the operational phase of this Sectoral Annex to the
by clicking on: MRA.
Draft Guideline on Plastic Primary Packaging Materials
A public statement on the MRA can be seen by clicking
I. C. Guideline on Stability Testing for Active on:
Substances and Medicinal Products (Marketed EC-Japan MRA Statement
in the EU) that are Manufactured in Climatic
The results of this Agreement should be to make life easi-
Zones III and IV. er for companies in the EU that export medicines to or
Draft guidance has been issued extending the existing sta- import medicines from Japan. You can find more informa-
bility guideline to cover products made in hot and dry or tion about this and other MRAs on the EMEA’s website at
hot and humid climatic zones that are to be marketed in the address given on page 2.
the EU. The closing date for comments be sent (to the
EMEA) is the end of August 2004.
To see a copy of this document click on:
Draft Guideline on Stability Testing FOR ALL YOUR QUERIES, PLEASE CONTACT
I.D. Guideline on the Active Substance Master IAGT TUTOR STEVE FAIRCHILD ON;
File Procedure (European Drug Master File - steve.fairchild@iagtgroup.com
EDMF)
An updated version of this guidance document has been To subscribe to the IAGT GMP Review, please
published. This will come into operation on August 31st send an e-mail to:
subscribe@iagtgroup.com
www.iagtgroup.com
A C A D E MY INTERNATIONAL ACADEMY OF GMP TRAINING (IAGT)
GMP REVIEW
AL
TE R N A TI O N
OF
G MP T RAIN (cont’d)
IN
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TH G
© IAGT,2004