Questions and Answers on the Sources of Purified Water and Water for Injection (8.17 – Daily Q&A)
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Regarding the sources of water for purified water and water for injection (8.17 – Daily Q&A): 1. According to Article 96 of the Good Manufacturing Practice for Pharmaceutical Products (2010 version), water used in pharmaceutical production should be obtained from drinking water at minimum. 2. According to the overview in 3.1.1 of the «Guidelines for GMP of Drugs (Facilities and Equipment · Water Systems)», the quality of raw water must meet drinking water standards before it can be used as the starting material for pharmaceutical water or purified water. 3. According to the Pharmacopoeia of China (2010 edition), water for injection is obtained by using purified water as the raw material and through distillation.
Sea friends: This post serves as an explanation for the answers to the two multiple-choice questions in the “8.17 - Answer Questions Daily” section. There’s no need for anyone to decide what is right or wrong, as the above three points are all taken from regulations and guidelines. Absolutely correct{:2_30:}
Request a flowchart for water injection. :)Thank you!