这个指南可以提供参考：

CVM 169 Guidance on DS CMC information-20100806

Starting Materials：

For application purposes, starting materials mark the beginning of the manufacturing process described in an application. The starting material for application purposes can differ from the active pharmaceutical ingredient (API) starting material, which marks the point in the manufacturing process from which appropriate GMP should be applied (as defined in ICH Q7A: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients). In general, the starting material and API starting material should be the same for a synthetic drug substance. However for a drug substance derived from a biological source, the starting material (e.g., plant) and API starting material (e.g., extract) can be different. In this case, information on the biological source (e.g., potential pathogens, herbicides, pesticides) is warranted in the application so FDA can evaluate the suitability of the biological source as a starting material for drug manufacture (see Attachment 2). The recommendations for starting materials provided in this guidance are for application purposes. See ICH Q7A for recommendations on API starting materials.

Starting materials for a synthetic drug substance are chemical compounds of defined molecular structure that contribute to the structure of the drug substance. A proposed starting material for a synthetic drug substance should be chosen so that sufficient information will be available to FDA on the manufacturing process to evaluate the safety and quality of the drug substance. The FDA considers (1) cells; (2) plants, plant parts, macroscopic fungi, or algae; or (3) animal tissues, organs, or body fluid from which the drug substance is derived to be the starting material for a drug substance derived from a biological source. For semisynthetic processes, information should be provided for the biological source starting material and starting materials of synthetic origin, if there are any.

我们也有经典的发酵产品，我们的起始物料是工作细胞库。

在ICH Q7中的18.14中讲了：本指南是从细胞培养/发酵步骤开始要求GMP的，但是之前的步骤（如，细胞库的建立）应该在适当的工艺控制下进行。本指南覆盖的细胞培养/发酵从一支细胞库的细胞用于生产开始。

在今年6月发布的ICH Q7问答中，有如下表述：

18. SPECIFIC GUIDANCE FOR APIS MANUFACTURED BY CELL CULTURE/FERMENTATION

ICHQ7中的18.14“本指南覆盖的细胞培养/发酵”中的发酵指的是经典发酵，不是生物技术发酵/细胞培养。尽管ICH Q7指南不适用于细胞进入经典发酵工艺之前的【参考ICH Q7, 1.3节】，但细胞库的建立应该有适当水平的GMP控制。

但是，这两节没有提 发酵产品的 起始物料问题。

EMA Use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products指南有如下表述：

According to Dir. 2001/83/EC, for biological medicinal products, “starting materials shall mean any substance of biological origin such as micro-organisms, organs and tissues of either plant or animal origin, cells or fluids (including blood or plasma) of human or animal origin, and biotechnological cell constructs (cell substrates, whether they are recombinant or not, including primary cells).”

所以对于生物技术产品，是有起始物料的定义及规定的。

@Hubert，你所指的经典发酵，是生产的化药吧，我也在找问题的答案。