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Is distribution of Investigational Medicinal Products covered by the new Guidelines on Good Distribution Practice (GDP)? What needs to be considered can be found here.
GMP News: IMPs: How do GDP Guidelines apply?
The 2013 Guidelines on Good Distribution Practice (2013/C 343/01) apply to medicinal products for human use. Investigational Medicinal Products (IMPs) are also medicinal products for human use. But is IMP distribution really covered by the new Guidelines? The Guidelines focus on wholesale distribution of medicinal products. And IMPs are normally not distributed via wholesalers. However IMPs are not particularly excluded. The Guideline may therefore give some guidance on how to supply clinical trial material. Better guidance might be given by the Questions and Answers documents of the European Medicines Agency (EMA). In the part on supplementary requirements, Annex 13, a few Q&As are dealing with storage and transportation of IMPs.
When it comes to transport of IMPs from the manufacturer to the distributor or investigator sites, the sponsor is responsible for controlling the distribution chain and assuring “that IMPs are stored, transported, and handled in a suitable manner”. The responsibility for storage and transportation lies with the manufacturer or an importer, when the IMP comes from outside the EU. To define the specific responsibilities of the parties involved, a contract should be in place.
During storage and transportation, conditions should at least be monitored. The sponsor should define the applicable storage (and transport) conditions for the IMPs. When the IMP arrives at the investigator site, IMPs should be stored in a restricted area where appropriate, with ongoing monitoring. Everything should be defined in SOPs.
Definition of Non Investigational Medicinal Products. (NIMPs). To be included in. The rules governing medicinal products in the European Union. Volume 10.
Mar 18, 2011 – Guidance on investigational medicinal products (IMPs) and othermedicinal products used in clinical trials (2007). Description of changes:.
Investigational Medicinal Product (IMP). A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a …
Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials. To be included in. The rules governing medicinal …
May 23, 2013 – My investigational medicinal product (IMP) unit is engaged upon reconstituting sterile injections and then giving them to the clinical trial …
Apr 2, 2013 – Is the product an investigational medicinal product (IMP) or a non-investigational medicinal product (NIMP)? Clinical trials in the UK are …
Clinical Trials of Investigational Medicinal Products (CTIMPs) must also adhere to the European Clinical Trials Directive (2001/20/EC) , the Medicines for Human …
GMP Handbooks with all major GMP and GDP Guidelines
Everyone involved in the GMP/GDP environment needs to use the current GMP and GDP Guidelines for reference. The ECA offers a range of booklets with all major Guidelines such as the EU GMP Guide (with all current Annexes), the new EU GDP Guideline, the FDA cGMP Guide and many more. You can order the GMP booklets here.http://www.gmp-compliance.org/eca_handbuecher.html
ECA Good Practice Guide on Validation
(1st Edition of October 2012)
This document is intended to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach (“what to do”). On the other hand, it also serves as a supporting guide for the implementation (“how to do”). The guide contains 163 pages divided in 5 chapters and 4 annexes. The topics covered are among others:•Risk based qualification and validation legacy products
•Case study about process validation in biopharmaceutical manufacturing
•Case study about continuous process verification
•Paperback in the handy format 14,8 x 21 cm
Price*: € 149 Non ECA Members, € 99 ECA Members
Booksellers receive a 15% discount – please ask for a COUPON CODE before ordering!
If you want to use the major GMP Guidelines on your smartphone or tablet we recommend to use the free of charge GMP Web App developed by the ECA Academy
The new GMP WebApp from ECA
ECA is pleased to announce a major development: now you can have all GMP information on your smartphone or Tablet PC (e.g. iPad) – with the new free of charge ECA GMP WebApp.
The unique new WebApp provides a number of GMP features. The App, which works on all smartphones (Apple and Android), is a useful tool for all professionals in the GMP environment. To open it, just go to app.gmp-compliance.org in your browser and the WebApp opens immediately.
To use the App in a convenient way you need to add the ECA icon to the Home screen (see below).
From ECA‘s weekly GMP Newsletter you are used to get the latest trends in the GMP environment. Now you can have these news at hand and keep track of all GMP developments any time. You will always find the latest GMP News on your App.
Major GMP Guidelines
The App allows you to access the major GMP Guidelines very easily. Whenever a revised GMP Guide is published the document is available without any update of the App. So you can always check the relevant Guidelines in seconds.
If you are looking for additional GMP information, the „Search“ function is very helpful. Just enter a keyword and select a specific database – or just search in all databases. The GMP Database contains hundreds of GMP articles and more than 1.000 GMP Guidelines. You do not need to search on different websites for the information. The GMP Database provides the links to the most relevant information.
GMP Courses & Conferences
On the ECA website you can scroll a list with all currently offered courses and conferences. The new WebApp does provide that list as well. Simply go on „GMP Courses & Conferences“ to access the complete ECA course and conference programme any time. If you just want to get a list with courses and conferences in a certain area, simply use the „GMP Search“ function decsribed before. And… by the way… if you found the programme you were just looking for… you can even register by using the App.
GMP Guideline Manager
Access to more than 1.200 GMP Guidelines This function is an exclusive service for ECA Members (Company Members will get access for all employees*). After login you will have access to all GMP Guidelines from EU/EMA, FDA, ICH, PIC/S, ICH, APIC, IPEC and WHO. To log in simply use your user name and password from your ECA Membership account. ECA Members have access to two so called Webtrees. One Guideline Tree is structured according to GMP topics. The second Guideline Tree is structured according to authorities. By using the Guideline Trees you can easily access the Guideline of interest.
* Employees of all sites in the country in which the company signed up for the membership.