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Chapter Law Content

Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 7 Manufacturing Process Control
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.
Article 31
Chinese herbal medicine factories shall establish in writing process control procedures; aforesaid procedures shall be approved by the quality control department. Where actual operations deviate from documented procedures, aforesaid deviation shall be recorded, a determination of how to handle the deviation shall be made, and an explanation shall be given.
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.
Article 33
Chinese herbal medicine factories shall clearly mark the contents and product batch manufacturing stage dates and times of mixing and storage containers, production lines and main manufacturing facilities used in the production and manufacture of each product batch, and enter the information into the batch manufacturing records.
Article 34
In regard to the quantities of raw materials used by Chinese herbal medicine factories in the manufacture of products, the amounts of active ingredients in each product batch may not fall below the nominal quantity.
Weighing, dividing and other procedures carried out on raw materials shall be performed in designated segregation areas, and shall be appropriately supervised and controlled.
Documented operational procedures shall include detailed test and control procedures for representative samples from each batch of semi-finished or intermediate products.
During the manufacturing and production process, the quality control departments of pharmaceutical factories shall carry out tests on semi-finished or intermediate products in accordance with established test procedures, thereby determining whether to approve aforesaid products for use; semi-finished or intermediate products that are not approved for use shall be labeled to this effect and kept isolated.
Article 35
Chinese herbal medicine factories shall include appropriate measures to prevent contamination by harmful microorganisms in written operation procedures.