Pharmaceutical Process Validation (Thẩm định quy trình sản xuất thuốc)

 1. Hướng dẫn của IVT (Institue of Validation Technology)

  a. Process design special edition (Stage 1)

  b. Process performance qualification special edition (Stage 2)

  c. Continued process verification special edition (Stage 3)

   d. Statistics in process validation special edition

2. Hướng dẫn của ISPE (International Society of Pharmaceutical Engineering)

   ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation