Certification of dietary supplements does not do without the development of regulatory documentation for the product. For carrying out work on hygienic examination and registration of dietary supplements the manufacturer, supplier or authorized representative provides various packages of documents depending on the origin of products. Thus, the technical documents on the dietary supplement of Russian production imply technical specifications, technological instructions, certificates of quality and safety, etc.

Technical specifications (TS) are developed for a group of dietary supplements of one kind or for one nomenclature unit.  According to Sanitary Rules and Regulations 2.3.2.1290-03 “Hygienic requirements for the organization of production and circulation of dietary supplements (dietary supplements)”, the specification on dietary supplements contains the following sections:

1. Introduction
2. Technical requirements for raw materials
3. Technical requirements for finished products, including packaging and labeling requirements
4. Requirements for safety of production and environmental protection
5. The order of organization and production control
6. Acceptance procedure
7. Methods of control, including indicators of authenticity of products
8. Instructions for use
9. Manufacturer’s warranties
10. The list of normative and technical documents, which are referenced in the specification of supplements.

After the registration of the dietary supplement of Russian production, the specification number is placed on the product labeling.

The technological instruction (technological regulations) contains the main part and annexes:

The main part includes:

1. Introduction;
2. Technical requirements;
3. The norms of consumption of raw materials;
4. Formulation
5. Description and graphic diagram of the technological process, including the process of preparation of raw materials;
6. Requirements for technological equipment;
7. Production control.

The annexes contain:
1.Register of technological control;

2.Graphical diagram of the technological process of production;

3.List of recommended equipment;

4.Diagram of critical control points indicating controlled parameters.

For the documents necessary for the registration of foreign dietary supplements, please read here (link will be available soon).

References:

1. Sanitary Rules and Regulations 2.3.2.1290-03 “Hygienic requirements for the organization of production and circulation of dietary supplements to food (dietary supplement)”
2. TR TU 21/2011
3. MG 2.3.2.721-98 Determination of safety and efficacy of dietary supplements