Deutsches Institut fur Normung e. V.

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
 N EN ISO 13408-1

Annotation

This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

NOTE This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regional jurisdictions

Автоматический перевод:

Стерильная обработка продуктов здравоохранения - Часть 1: Общие требования (13408-1:2008 ISO, включая AMD 1:2013)

Эта часть ISO 13408 определяет общие требования для и предлагает руководство на, процессы, программы и процедуры для развития, проверки и обычного контроля производственного процесса для стерильным образом обработанных продуктов здравоохранения.