Pharmaceutical Good Manufacturing Practice Regulations Article 30
To insure that each product batch is of consistent quality, Chinese herbal medicine factories shall have designated personnel establish process control standards for every product, and have announced the standards independently reviewed by other personnel.The process control standards mentioned in the preceding Paragraph shall include the following items:(1) Product name, content and dosage form;(2) Name and weight or volume of each active ingredient per product by unit weight, volume or dosage form, and total weight or volume of unit dosage form;(3) Names and specifications of all raw materials; if a code name or number is used to represent a raw material, aforesaid code shall be sufficient to determine the nature of the material;(4) Quantity of each product batch;(5) Weight or volume required by each raw material for each product batch. However, the quantities of raw materials used to produce a given dosage form may be increased or varied within a reasonable range; aforesaid range shall be explained in the manufacturing process control standards;(6) Appropriate theoretical weights or volumes for each stage of the manufacturing process;(7) Theoretical production quantity, including upper and lower production quantity limits expressed as percentage;(8) Product container, cap and packaging material specifications (along with label signed and dated by inspector and samples or copies of all other labeling);(9) Complete manufacturing and control manuals, sampling and test procedures, specifications and guidelines.
中文原文 藥物優良製造準則第30條
中藥廠為求每批產品品質一致，應由專人訂定每一產品之製造管制標準書，並由另一人獨立核查。
前項製造管制標準書，應包括下列事項：
一、品名、含量及劑型。
二、產品單位重量、容量或劑型所含每一有效成分之名稱及重量或容量，與單位劑型之全重量或容量。
三、所有原料之名稱、規格，如加冠代號者，應足以表現其特質。
四、每批產品之產量。
五、每批產品所需每一原料之重量或容量。
但製造劑型所需之原料，得有合理之增量及偏差範圍，且應在製造管制標準書加以闡釋。
六、製造過程中適當階段之理論重量或容量。
七、理論產量，包括理論產量百分率之上、下限。
八、產品容器、封蓋及包裝材料之規格，應附簽有核定人姓名日期之標籤及其他所有標示之樣品或副本。
九、完整之製造與管制說明書、取樣與檢驗程序、規格及應注意事項。
前項製造管制標準書，應包括下列事項：
一、品名、含量及劑型。
二、產品單位重量、容量或劑型所含每一有效成分之名稱及重量或容量，與單位劑型之全重量或容量。
三、所有原料之名稱、規格，如加冠代號者，應足以表現其特質。
四、每批產品之產量。
五、每批產品所需每一原料之重量或容量。
但製造劑型所需之原料，得有合理之增量及偏差範圍，且應在製造管制標準書加以闡釋。
六、製造過程中適當階段之理論重量或容量。
七、理論產量，包括理論產量百分率之上、下限。
八、產品容器、封蓋及包裝材料之規格，應附簽有核定人姓名日期之標籤及其他所有標示之樣品或副本。
九、完整之製造與管制說明書、取樣與檢驗程序、規格及應注意事項。