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 March 2004
Issue III
IN
E IN
TH G
This month’s GMP News covers: 2004 and will incorporate:
n New and revised EU Guidelines n The Certificate of Suitability System of the European
n The introduction of bar coding on medicines in the USA Pharmacopoeia
n Developments with the Mutual Recognition Agreement n The Common Technical Document format for market-
between the EU and Japan. ing authorisation applications. (IMPs)
To see this guideline click on:
EDMF Guideline
DEVELOPMENTS IN GMP AND
REGULATORY REQUIREMENTS II. UNITED STATES OF AMERICA
II. A. FDA
Bar Code Label Requirement for Human Drug
I. EUROPE Products and Biological Products - 21 CFR Parts
201, 606, and 610 (Final Rule)
I.A. Further revision of the Compilation of EU The FDA is to issue a final rule to introduce a requirement
Procedures on Inspections and the Exchange of for linear bar codes to appear on most medicines sold in
Information the USA.. The reason behind this is to reduce the number
The European Medicines Agency EMEA has issued the sec- of medication errors.
ond revision of the Compilation of Procedures Used by the Products will have to be brought into compliance over the
GMP Inspectorates of the EU Member States. This follows next 2 years:
the last revision in December 2003.
USA bar code requirements
The additions to this version are:
n A revised section on the training and qualifications of
GMP inspectors
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
E IN
TH G
USEFUL ADDRESSES / LINKS FDA CBER Guidelines/Points to Consider:
http://www.fda.gov/cber/guidelines.htm
Please note that some of the addresses include underscored spaces,
which may be difficult to see as they appear in written documents.
You will also need to use Adobe Acrobat Reader, which can be down- FDA Human Drugs GMP Notes:
loaded from: http://www.adobe.com/products/acrobat http://www.fda.gov/cder/dmpq/cgmpnotes.htm
British Pharmacopoeia (BP): Japanese Ministry of Health, Labor & Welfare
http://www.pharmacopoeia.org.uk (MHW):
http://www.mhlw.go.jp/english
Canadian HPFB Inspectorate:
h t t p : / / w w w . h c - s c . g c . c a / h p f b -
International Conference on Harmonisation
dgpsa/inspectorate/index_e.html
(ICH):
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEM
European Agency for the Evaluation of PLATE=254
Medicinal Products (EMEA):
http://www.emea.eu.int
International Society of Pharmaceutical
Engineers (ISPE):
European Agency for the Evaluation of http://www.ispe.org
Medicinal Products Inspections Sector:
http://www.emea.eu.int/Inspections/index.html
International Pharmaceutical Federation (FIP):
http://www.fip.nl
European Chemical Industry Council – Active
Pharmaceutical Ingredients Sector International Pharmaceutical Excipients
(CEFIC/APIC): Council (IPEC):
http://apic.cefic.org
http://www.ipec.org
European Guide to GMP:
The UK Medicines and Health Care Products
http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm
Regulatory Agency (MHRA):
http://www.mhra.gov.uk
European Guide to GMP – updates etc:
http://pharmacos.eudra.org/F2/pharmacos/gmp_doc.htm
The Irish Medicines Board:
http://www.imb.ie
European Compilation of Procedures for GMP
Inspections:
Mutual Recognition Agreements (MRA’s):
http://www.emea.eu.int/Inspections/docs/335103en.pdf
http://www.emea.eu.int/Inspections/MRA.html
European Federation of Pharmaceutical
The Pharmaceutical Quality Group (PQG):
Industries and Federations (EFPIA): http://www.pqg.org/welcome.asp
http://www.efpia.org
Pharmaceutical and Research Manufacturers of
European Guidelines on Quality, Safety & America (PhRMA):
Efficacy: http://www.phrma.org
http://www.emea.eu.int/sitemap.htm
Pan European Regulatory Forum (PERF III)
European Pharmacopoeia (Ph Eur): http://perf.eudra.org/perf3/perf1.html#
http://www.pheur.org
Pharmaceutical Inspection Co-operation
FDA “Portal” - providing access to the different Scheme (PIC/S)-GMP Guide & Basic Standards:
parts of their website: http://www.picscheme.org/index.htm
http://www.fda.gov/oc/industry/default.htm
UK Official Documents Including the “Orange
FDA GMP Regulations (CFR21): Guide” and Medicines Legislation:
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211 http://www.tso.co.uk/bookshop/bookstore.asp
_01.html
United States Pharmacopoeia (USP):
FDA Inspections Operation Manual: http://www.usp.org
http://www.fda.gov/ora/inspect_ref/iom/iomtc.html
World Health Organisation GMP Information
FDA Inspection Guides
(WHO):
http://www.fda.gov/ora/inspect_ref/igs/iglist.html
http://www.who.int/medicines/organization/qsm/activities
/qualityassurance/gmp/gmpcover.html
© IAGT,2004
