Course Overview:

The general rules for pharmaceutical water in the Chinese Pharmacopoeia will be revised in the new edition, and non distilled injection water is expected to be introduced in the new 2025 edition of the Chinese Pharmacopoeia. In this context, it is a development opportunity for the entire pharmaceutical industry, including pharmaceutical production, design, construction, and water system suppliers. For example, using membrane injection water to enter pharmaceutical production enterprises will greatly reduce energy costs; The water machine supplier will add a new water machine with high added value. This study will introduce the general rules for pharmaceutical water in the new pharmacopoeia 0261, and focus on the membrane injection water that everyone is concerned about.

Course Catalog:

1. Background of the revision of the General Principles for Pharmaceutical Water in the Chinese Pharmacopoeia 2. Regulatory requirements for WFI

3. Risks of membrane based WFI preparation - Microbial contamination 4. Regulatory requirements for microbial control in non distilled production injection water 5. Process analysis technology, pretreatment system, and purification system for non distilled injection water preparation