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LOGFILE 26 2012 Good Distribution Practice GDP

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LOGFILE 26 2012 Good Distribution Practice GDP

Uploaded by

Audrius RIMKUS
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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LOGFILE No.

26 / September 2012 Maas & Peither AG – GMP-Verlag

Good Distribution Practice - important regulations in the European


framework are the regulations of the WHO
Current Regulations and those of Europe. If you intend to de-
liver to one of the countries below you
have to consider the appropriate local
requirement. (Documents available in the
internet are linked in the text.)

Author: 1. WHO: Good Distribution Practices


Thomas Peither, for pharmaceutical products TRS No.
Maas & Peither AG 957, Annex 5 (2010)
 Weblink

2. WHO: Model requirements for the


storage and transport of time and tem-
Good Distribution Practice (GDP) is cur- perature sensitive pharmaceutical
rently discussed in a lot of companies. products TRS No. 961, Annex 9 (2011)
Reasons for continuing discussions are:  Weblink
¬ Upcoming complexity of the global
supply chain and distribution 3. Europe: Commission Guidelines on
¬ Increased numbers of incidents Good Distribution Practice for Medici-
¬ Increased requirements in the EU GDP nal Products for Human Use (Draft
draft regulation 2011)
 Weblink
There are a significant number of regula-
tions in place that have to be followed 4. Europe: International Pharmaceutical
when transporting drug products. In the Excipients Council (IPEC) IPEC Good
following we would like to give you an up- Distribution Practices Audit Guideline
to-date overview of the current GDP regu-  Weblink
lations for the handling and transportation
of pharmaceutical products. 5. Europe: Consolidated Directive
2001/83/EC
As a consequence of the discussions GDP  Weblink
is divided into the following topics:
¬ Temperature Control Management 6. IATA: Logistics for Temperature Sensi-
(TCM) tive healthcare products (chapter 17)
¬ Distribution Control Systems (DCS)
¬ Good Importation Practices (GIPs) 7. FDA: (Congress) to Revise Component
of GMP’s (and develop new GDP’s) to
The goal of these regulations is to define related to Supply Chain Security (3 “Bills”
measures for a global product protection to amend the FD&C act)
(GPP).
8. USP: Chapter 1118 - Monitoring device-
In this feature we concentrate on general Time, Temperature and Humidity (and
GDP regulations as well as on tempera- others)
ture control management regulations.  Weblink

GDP Regulations 9. USP: Chapter 1083 Good Distribution


Practices
The following published regulations and  Weblink
guidelines are relevant for the distribution
of pharmaceutical products. The most

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© 2012 Maas & Peither AG – GMP Publishing, Germany, all rights reserved Page 1/3
LOGFILE No. 26 / September 2012 Maas & Peither AG – GMP-Verlag

10. Saudi Food & Drug Authority: Tem- 22. Canada: Health Canada: Guidelines
perature Monitors for Temperature Control of Drug Products
 Weblink during Storage and Transport GUI-0069
 Weblink
11. Taiwan: Precaution of on-site sampling
for vaccine testing and sealing operation 23. Ireland: Irish Medicines Board (IMB) -
(Draft) Medicinal Products (Prescription and
Control of Supply) (Amendment) Regula-
12. Romanian Directive: Legislation tions 2007 (SI 201 of 2007)
Change - Control of temperature/humidity  Weblink
during transportation
24. Ireland: IMB Guide to Control and
13. Singapore: Health Sciences Authority Monitoring of Storage and Transportation
Guidance notes on GDP’ (Draft) Temperature Conditions for Medical Prod-
 Weblink ucts and Active Substances
 Weblink
14. Czech Republic: GDP Guidelines: DIS-
15 version 1 Monitoring and temperature 25. Japan: Biological Pharma revision
control during storage and transport of H15.5.15 (rPAL)
medicinal products
 Weblink 26. UK: MHRA - GDP Risk Assessment
Strategy
15. Czech Republic: GDP Guidelines: DIS- Weblink
11 Guidelines for correct distribution prac-
tice of human medicinal products 27. UK: MHRA – Good Distribution Prac-
 Weblink tice: Guidance and Legislation
 Weblink
16. India: Pharma Manufacturers Guide-
lines (not issued by the Gov’t but endorsed 28. Israel: The Status of Current GDP
by the Gov’t) Regulations in Israel (adopt EU &/or
 Weblink WHO)

17. Egypt: Minister Decree for Wholesal- 29. Turkey: GDP’s temperature manage-
ers – Circular No. 4/2009 ment and interoperable serializa-
tion/pedigree/TnT
18. Australia: Code of Good Wholesaling
Practice 30. Saudi Arabia: Control and monitor
 Weblink 100% of pharma imports (cold chain by
March 1st and CRT by June 1st)
19. Indonesia: GMP Requirements on
warehousing or distribution 31. ASEAN: GMP Guidelines
 Weblink
20. Pakistan: Drug Act of 1976
 Weblink Technical Reports
21. Brazil: Resolution RDC No. 234 (ac- In addition the PDA (Parenteral Drug
celerated vs. real time data) Association) has published a number of
 Weblink Technical Reports (TR) supporting the
interpretation of guidelines.

1. TR 39: Guidance for Temperature Con-


trolled Medicinal Products

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© 2012 Maas & Peither AG – GMP Publishing, Germany, all rights reserved Page 2/3
LOGFILE No. 26 / September 2012 Maas & Peither AG – GMP-Verlag

2. TR 46: The Last Mile, Guidance for


GDPs for Pharma Products to the End
User
GMP MANUAL
Good Manufacturing Practice &
3. TR 52: Guidance for GDPs for the Implementation
Pharmaceutical Supply Chain (MoH
GDPs) Includes 2 Parts:
GMP in Practice: 23 chapters written by
4. TR 53: Stability Testing to Support internationally renown industry experts.
Distribution of New Drug Products (ICH)
GMP Regulations: 8 chapters with the
most important GMP regulations.
5. TR 54: Implementation of Quality Risk
Mgt (QRM) for pharma and Biotech
Mfg’ing Operations
 Weblink

References:

Presentation of Dave Ulrich, PDA Annual


Meeting, Phoenix, AZ, USA, April 18, 2012

Presentation of David Ulrich, PDA März Paper Version incl. CD-ROM


2011 (currently 9 binders)
 Weblink

Coolpack Website
 Weblink

The internet links have been checked on


September 13, 2012.

Autor: CD-ROM only


Thomas Peither

Maas & Peither AG, GMP Publishing

Karlstrasse 2
79650 Schopfheim
Germany

[email protected]
Online (choose between Single User
Licence or Corporate Licence)

More information:
http://www.gmp-publishing.com/en/gmp-products.html

For a free online-trial contact:


[email protected]

http://www.gmp-publishing.com/

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