Terms used in Chapter 2 are defined as follows:
(1) Raw materials: any materials used in the manufacture of pharmaceuticals, including those that do not remain in the end product.
(2) Semi-finished or intermediate products: any products that are obtained during the manufacturing process, and that, with further processing, can become finished products.
(3) Products: active pharmaceutical ingredients, or preparations that contain active pharmaceutical ingredients and may contain other non-active ingredients, for which all manufacturing processes have been completed.
(4) Labeling: refers to all text and graphics that appear on labels, instruction sheets or packages, or that come with products.
(5) Packaging materials: include product containers, caps, and any materials used in the outer packages of products.
(6) End products: refer to pharmaceutical products that have been packaged, and whose outer packaging clearly indicates the contents therein.
(7) Batch: refers to a specific amount of pharmaceutical or other substance produced under a single set of manufacturing instructions, and that is consistent in character and quality. However, under conditions of continuous production, a batch refers to a specific amount of pharmaceutical or other substance produced within a specific time period, or that, within specific parameters, is consistent in character and quality.
(8) Batch number: refers to any definite combination of letters, numbers or other symbols that can be used to look up comprehensive information on a batch of products or other substances.
(9) Content: the unit quantity of the components of a pharmaceutical.
(10) Validation: written documentation attesting that any procedure, manufacturing process, mechanical device, raw material, action or system is capable of achieving its anticipated effect.
(11) Active pharmaceutical ingredient: an active substance or ingredient that is produced through physical, chemical processes for use in the manufacture of a pharmaceutical product.
(12) Tamper-proof packaging: packaging with an identifying mark or barrier that enables consumers to clearly identify the contained product.
(13) Clinical trial drug: a pharmaceutical or placebo that is undergoing clinical trials, and has not yet obtained approval.

Chinese herbal medicine manufacturers shall implement validation procedures; the categories to be implemented, as well as the implementation methods and schedule, shall be announced by the central competent health authority.

The manufacturing, processing, re-packaging and packaging of raw materials of Chinese herbal medicine shall be governed by the provisions of Chapter 2; the categories to be implemented, as well as the implementation methods and schedule, shall be announced by the central competent health authority.