929附录2起始物料的取样(英文)

WHO Technical Report Series, No. 929, 2005

Annex 2

Good manufacturing practices: requirement for the sampling of starting materials (amendment)

Introduction

The WHO Expert Committee on Pharmaceutical Preparations, at its thirty-seventh meeting, adopted Good Manufacturing Practices for pharmaceutical products: main principles, which were published in its report (1). At its thirty-ninth meeting, the Committee considered a proposal to amend the WHO good manufacturing practices (GMP) requirement for sampling of starting materials because it is not consis-tent with the requirement of other GMP documents such as the European Union GMP Guide which allows reduced sampling of start-ing material containers under certain conditions. The Committee rec-ommended that, in the interests of harmonization, the proposal should be adopted in amending paragraph 17.15 of the main text of the GMP.

Add to section 17.15 “An identity test should be conducted on a sample from each container of starting material (see also section

14.14)” the following:

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.

This validation should take account of at least the following aspects:—the nature and status of the manufacturer and of the supplier and their understanding of the GMP requirements;

—the quality assurance system of the manufacturer of the starting material;

—the manufacturing conditions under which the starting material is produced and controlled; and

—the nature of the starting material and the medicinal products in which it will be used.

Under such a system it is possible that a validated procedure for exemption from the requirement for identity testing of each incoming container of starting material could be accepted for the

following:

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—starting materials coming from a single product manufacturer or plant; or

—starting materials coming directly from a manufacturer, or in the manufacturer’s sealed container where there is a history of reli-

ability, 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.

It is improbable that such a procedure could be satisfactorily vali-dated for either:

—starting materials supplied by intermediaries, such as brokers, where the source of manufacture is unknown or not audited; or —starting materials for use in parenteral products.

Reference

1.Good Manufacturing Practices for pharmaceutical products: main principles.

In: WHO Expert Committee on Pharmaceutical Preparations. Thirty-seventh

report. Geneva, World Health Organization, 2003 (WHO Technical Report

Series, No. 908), Annex 4.

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