ISPE and CCPIE Develop Training Courses for Chinese Market

International Society for Pharmaceutical Engineering (ISPE) and the China Centre for Pharmaceutical International Exchange (CCPIE) will partner to bring a series of training courses for the Chinese pharmaceutical industry on June 1-5 in Shanghai and June 8-12 in Beijing.

Gordon Farquharson will be presenting the two training courses on sterile drug manufacturing facilities and pharmaceutical water systems at each of these events.

Sterile Drug Manufacturing Facilities: The Applying ISPE Baseline Guide, FDA, EU/PICS and World Health Organization (WHO) Principles to Design and Operation course, will review ISPE's Sterile Manufacturing Facilities Baseline Guide.

The US Food and Drug Administration's (FDA) 2004 Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, and the new March 2009 implementation of Annex 1 of the EU Good Manufacturing Practice (GMP), will help participants to gain an understanding of the key requirements and GMPs for sterile products manufacturing facilities. Additional information will be reviewed from the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and from the World Health Organization (WHO).

During the Pharmaceutical Waster Systems: Regulation, Purification, Distribution and Validation course, participants will review the principles of design and operation of water systems used directly in pharmaceutical manufacturing. This includes the regulatory requirements, fundamental concepts, and principles for systems used to generate, store and distribute both compendial and non-compendial waters. These concepts include the specification, design, installation, operation, testing, validation, and maintenance of components and systems.