scope:

1.1 This International Standard 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. 1.2 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 this series of standards. NOTE 1 This International Standard 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. NOTE 2 The principles described in this International standard may be applied to products for clinical investigation. However, flexibility in the application of concepts such as the aseptic processing master plan may be needed for clinical trial materials manufacture.