| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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14-592
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| Standard | |
ISO 13408-1 Third edition 2023-08
Aseptic processing of health care products - Part 1: General requirements |
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Scope/AbstractThis document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
| FDA recognition of ISO 13408-1 Second edition 2008-06 [Including: Amendment 1 (2013)] [Rec# 14-427] will be superseded by recognition of ISO 13408-1 Third edition 2023-08 [Rec# 14-592]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-427] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 14-427] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, issued September 2004.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
