The International API GMP Guidance: ICH Q7 Implementation and Application

Venue: Philadelphia

Location: Philadelphia, PH, United States

Event Date/Time: Sep 21, 2010 End Date/Time: Sep 22, 2010
Registration Date: Sep 08, 2010
Early Registration Date: Jun 30, 2010
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Addressing Issues on Regulatory Requirements, Guidelines and Practical Approaches to API’s Manufacturing
This comprehensive 2-day program was developed along with FDA to train both regulatory (FDA) and Industry personnel. It was written by members of the ICH Q7A Expert Work Group and designed to teach both the meaning and intent of the API GMP.

The instructor was a voting member of the EWG that negotiated and wrote the Q7A Guidance as it has been adopted by the regulatory bodies in the USA, EU, and Japan.

Join This Important, Two Day Comprehensive & Interactive Course with Discussions on:

GMP considerations related to ICHQ7
History of API GMP Development
Requirements and Implementation of ICHQ7
Costs and benefits of manufacturing excipients in compliance with ICHQ7A guidelines
Quality Management and Creating Quality Units
Records and Documentation
Differences in Registration for Market Authorizations
Material Management
Managing Complaints and Recalls
Impact of ICHQ7 on Second and Third Parties
Evaluation of Suppliers
Cleaning Validation
Labeling of APIs and Intermediates
GMP in Laboratory Control
Change Control
Differences between API’s manufactured by Cell Culture(&)/ Fermentation to API’s manufactured by Chemical Synthesis
Audit Preparation with Consideration to GMP and ICH Requirements
As of 30th October 2005 EU law mandated manufacturers of medicinal and veterinary products for sale in the EU to use only APIs that have been produced in compliance with GMP (ICHQ7a). It is important that API production facilities operating under different national and international regulatory authorities not be required to meet diverse standards. For this reason, an Expert Working Group in ICH developed the ICH-Q7 document as a single standard that all suppliers must apply to production of APIs used in human drug products manufactured in any of the ICH signatory regions