Pharmaceutical Good Manufacturing Practice Regulations Article 32
To insure the each product batch is of consistent quality and integrity, Chinese herbal medicine factories shall take steps to evaluate and validate the consistency of process control operations, including related equipment and facilities, for each product; documented procedures for the validation of each manufacturing process shall also be established, and shall be complied with and validated on a regular basis.All original verification records and statistical analysis data related to evaluation and validation procedures shall be compiled and filed for future reference.
中文原文 藥物優良製造準則第32條
中藥廠為確保每一批產品品質之均一及完整性，應針對各產品有關之製程管制作業，包括相關設備及設施，加以評估確認其有效一致性，並建立各項製程確效之書面作業程序，供日後遵行及定期確認。
所有與評估確認作業有關之驗證原始紀錄及統計分析之處理資料，應予彙整並留存備查。
所有與評估確認作業有關之驗證原始紀錄及統計分析之處理資料，應予彙整並留存備查。