DST: For EU GMP sampling, item-by-item sampling identification is expensive for enterprises and is not easy to control, so how to control in the actual implementation process to meet the sampling requirements for materials:

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelinesChapter 5 - Production

EudraLex-Volume 4-Good Manufacturing Practice (GMP) Guide Chapter 5-Production

5.35 Manufacturers of finished products are responsible for any testing of starting materials2 as described in the marketing authorisation dossier. They can utilise partial or full test results from the approved starting material manufacturer but must, as a minimum, perform identification testing3 of each batch according to Annex 8.

The manufacturer of the 5.35 finished product is responsible for any testing of the starting materials described in the marketing authorization file. They may use some or all of the test results of an approved manufacturer of the starting material, but must at least perform the qualification test for each batch in accordance with Appendix 8.

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

ANNEX 8 SAMPLING OF STARTING AND PACKAGING MATERIALS

EudraLex-Volume 4-Good Manufacturing Practice (GMP) Guidelines

APPENDIX 8 SAMPLING OF START MATERIALS AND PACKAGING MATERIALS

Starting materials Starting Material

2.The identity of a complete batch of starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample. It is permissible to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled.

In general, the identity of the complete batch of starting material can only be ensured by taking a single sample from all containers and performing an identity test on each sample. Sampling of only a subset of containers for which verification procedures have been established is permitted to ensure that no individual containers are incorrectly labeled with the starting material.

DST: The verification procedure is mentioned here. Does the material supplier also need verification? Let's see what the verification requires:

3.This validation should take account of at least the following aspects: This verification should consider at least the following aspects:

— the nature and status of the manufacturer and of the supplier and their understanding of the GMP requirements of the Pharmaceutical Industry;

the nature and status of manufacturers and suppliers and their understanding of GMP requirements in the pharmaceutical industry;

-the Quality Assurance system of the manufacturer of the starting material;

— the manufacturing conditions under which the starting material is produced and controlled;生产和控制起始物料的制造条件；

-the nature of the starting material and the medicinal products in which it will be used. The nature of the starting material and the nature of the medicinal product with which it will be used.

Under such a system, it is possible that a validated procedure exempting identity testing of each incoming container of starting material could be accepted for:在这样的系统下，可以接受一个经过验证的程序，免除每个原料容器的身份测试，用于：

-starting materials coming from a single product manufacturer or plant; starting material from a single product manufacturer or plant;

— starting materials coming directly from a manufacturer or in the manufacturer’s sealed container where there is a history of reliability and regular audits of the manufacturer’s Quality Assurance system are conducted by the purchaser (the manufacturer of the medicinal product) or by an officially accredited body.直接来自制造商的起始物料或制造商具有可靠性历史的密封容器，由买方（药品制造商）或官方认可机构对制造商的质量保证体系进行定期审计。

It is improbable that a procedure could be satisfactorily validated for: The program is unlikely to be satisfactorily validated in:

-starting materials supplied by intermediaries such as brokers where the source of manufacture is unknown or not audited;

-starting materials for use in parenteral products. The starting material used to inject the product.

In view of the above, it can be concluded that according to the GMP guidelines in Volume 4 of EudraLex, the following requirements are required for sampling and identification of starting materials:

1. For the contents of each raw material container, appropriate procedures or measures should be established to ensure its identity. Samples taken from bulk containers shall be identified.

2. The manufacturer of the finished product is responsible for testing the starting material. Some or all of the test results of the approved starting material manufacturer may be used, but at least each batch must be subject to qualification testing.

3. Sampling procedures for starting materials should be validated, taking into account the nature and status of the manufacturer and supplier, the quality assurance system, production conditions, and the nature of the starting material and the nature of the pharmaceutical product to be used.

4. For starting materials from a single product manufacturer or factory, or starting materials directly provided by the manufacturer and with a reliability history, the identity test of each raw material container can be exempted through the verification procedure.

5. Procedures are unlikely to be satisfactorily validated for starting materials provided by brokers or for injection of products.

DST: In addition to the starting materials for injection, we can develop different sampling strategies for our suppliers of starting materials through the verification procedure provided in Appendix 8. If the supplier meets the requirements of the verification procedure, it is not necessary to sample each piece.