OA 中文
WHO good manufacturing practices for biological products Replacement of Annex 1 of WHO Technical Report Series, No. 822

1. Introduction

 Biological products can be defined according to their source material and method of manufacture. The source materials and methods employed in the manufacture of biological products for human use therefore represent critical factors in shaping their appropriate regulatory control. Biological products are derived from cells, tissues or microorganisms and reflect the inherent variability characteristic of living materials. The active substances in biological products are  often too complex to be fully characterized by utilizing physicochemical testing methods alone and may show a marked heterogeneity from one preparation and/or batch to the next. Consequently, special considerations are needed when manufacturing biological products in order to maintain consistency in product quality. Good manufacturing practices (GMP) for biological products were first published by WHO in 1992 (1). This current revision reflects subsequent developments that have taken place in science and technology, and in the application of risk-based approaches to GMP (2–14). The content of this document should be considered complementary to the general recommendations set out in the current WHO good manufacturing practices for pharmaceutical products: main principles (2) and in other WHO documents related specifically to the production and control of biological products. This document is intended to serve as a basis for establishing national guidelines for GMP for biological products. If a national regulatory authority(NRA) so desires, the guidance provided may be adopted as definitive national requirements, or modifications may be justified and made by the NRA in light of the risk–benefit balance and legal considerations in each authority. In such cases, it is recommended that any modification to the principles and technical specifications set out below should be made only on the condition that the modifications ensure product quality, safety and efficacy that are at least equivalent to that recommended in this document.

2. Scope

The guidance provided in this document applies to the manufacture, control and testing of biological products for human use – from starting materials and  preparations (including seed lots, cell banks and intermediates) to the finished product. Manufacturing procedures within the scope of this document include:■ growth of strains of microorganisms and eukaryotic cells;■ extraction of substances from biological tissues, including human, animal and plant tissues, and fungi;...

For more information, please refer to:

亚投娱乐官方网站_2018最新电玩城_云顶4008app 真钱牛牛平台牛_亚博手机app下载_betway体育下载 金沙线上赌上网站_葡京娱乐场网页游戏_360bet网络游戏 网上葡京注册开户_澳门凯旋门账号注册_北斗吉祥会员 网址 澳门国际网上游戏_星云娱乐官网二维码_西虹娱乐下载app 博猫游戏怎么注册_h5蓝月贪玩手游官网_银河娱乐场网页游戏 辉煌集团1147_在线娱乐场赌博注册_永信在线app下载 大丰收365网址_真钱赌场注册开户_送体验金的线上娱乐