Pharmaceutical Good Manufacturing Practice Regulations Article 50
Chinese herbal medicine factories shall make written records of product complaints, and keep aforesaid records in product complaint files; aforesaid files shall be stored in a suitable location, or in a facility where they can be easily accessed for inspection.The written records referred to in the preceding Paragraph shall be kept until the expiration date of the product in question, or for one year after the complaint was received, whichever period is longer. However, for products that do not require expiration dates, aforesaid records shall be kept for at least three years after the date of dispatch of the product in question.
中文原文 藥物優良製造準則第50條
中藥廠對於每一申訴所作之書面紀錄，應保存於產品申訴檔案中，並將檔案保存於適當場所或其他隨時可供稽查之設施中。
前項書面紀錄，應保存至該申訴產品保存期限或接到申訴後一年，以期間較長者為準。
但免於標示有效期間之產品，應至少保存至該申訴產品出廠後三年。
前項書面紀錄，應保存至該申訴產品保存期限或接到申訴後一年，以期間較長者為準。
但免於標示有效期間之產品，應至少保存至該申訴產品出廠後三年。