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Mini-Handbooks: Q7A



These handy pocketsize booklets are an ideal way to keep everyone informed of ICH technical requirements for registration of pharmaceuticals for human use. They are an exact copy of the ICH technical documents.

This guidance represents the FDA's current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing quality as developed by ICH. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.

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Member Price: $ 5.00 / € 4.00
Non-Member Price: $ 5.00 / € 4.00
Item #GMP045US

Format: 10x16 cm

Pages: 84

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