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GMP: ICH Q8, Q9, & Q10 Questions and Answers - now also in force in the USA

13.09.2012
The ICH document Q8,Q9, & Q10, Questions and Answers / Appendix Q&As from Training Sessions has also been published in the United States. ...

GMP: Finally published: new EU GMP Chapter 1 with comprehensive Changes

13.09.2012
The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called ...

GMP: Finally published: new EU GMP Chapter 7 on Outsourced Activities

13.09.2012
Chapter 7 of the EU GMP Guide \"Contract Manufacture and Analysis\" has been revised, and the Directorate-General for Health and Consumers (DG SANCO) of the European Commission recently published ...

EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes

06.09.2012
The EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any update of the annexes, except for those when the ...

GMP: FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI)

06.09.2012
The FDA announced via its Center for Devices and Radiological Health (CDRH) - which is also responsible for medical devices - the publication of requirements on harmonised designation of medical ...

GMP: FDA Dissolution Methods Database

06.09.2012
The U.S. Food and Drug Administration has created the FDA Dissolution Methods Database for drug products that do not have a drug product dissolution test method in the United States Pharmacopeia ...

EMA: Draft guideline on core summary of product characteristics and package leaflet for technetium (99mTc) sestamibi

29.08.2012
This guideline describes the information to be included in the summary of product characteristics and package leaflet for technetium (99mTc) sestamibi. ...

GMP: Continuous Manufacturing - FDA Perspective on Submissions and Implementation

29.08.2012
The advantages of Continuous Manufacturing (CM) are presented in a presentation entitled \"Continuous Manufacturing - FDA Perspective on Submissions and Implementation\". The presentation points ...

GMP: New Templates for GMP and GDP certificates published by EMA

29.08.2012
The compilation is a tool for facilitating co-operation between the GMP inspectorates of the Member States and a means of achieving harmonisation. ...

GMP: New Rules for the Importation of APIs - a European Commission Leaflet provides Information

23.08.2012
The rules for importing active substances for medicinal products for human use from third countries into the EU have been reformed. The European Commission has already published a document setting ...

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