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Resumen
The adoption of ICH Q7 by PIC/S occurred in May 2001 with the current version of the guideline having been available since 1 September 2007 as GMP PE 009 (Part II). The primary objective for implementing ICH Q7 is the reduction of the risks associated with the manufacturing quality of APIs and this cannot be achieved without an effective inspection system which addresses the specific aspects of the global API industry. The adoption of ICH Q7 as the first truly harmonised GMP guideline for active pharmaceutical ingredients (APIs) and the associated development of regulatory frameworks to implement the guideline as a regulatory standard mark the beginning of a new era of regulation for medicines.It is recognised that due to their background and experience the majority of GMP inspectors are more familiar with the inspection of finished products. Therefore, to assist inspectors not specialised in the inspection of API manufacturers this document has been developed to provide training and guidance for the preparation and performance of such inspections. This Aide-Memoire should also contribute to a harmonised approach for inspections of API manufacturers between the different PIC/S Members .At the time of issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence. This Aide-Memoire focuses on the preparation for inspections and chapters and/or sections of GMP PE 009 (Part II) which are specific to the inspection of API manufacturers or critical for the quality of APIs. For sections which include requirements similar to those in GMP Guide Part I devoted to Finished Products such as personnel, documentation, etc., please refer directly to GMP PE 009 (Part II). Emitida por International Commettee Harmonization (ICH) |
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| Domingo, 19/5/2013 |
