ISO 13408-1:2008

Standard
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Status: Check Published
Norwegian title: Aseptic processing of health care products — Part 1: General requirements
English title: Aseptic processing of health care products — Part 1: General requirements
Item type: Standard
Language: Engelsk
Edition: 2 (2008-06-10)
Supersedes: ISO 13408-1:1998 Alert Withdrawn
Number of pages: 45
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Scope: <sec id="sec_1.1"><label>1.1</label><p>This part of <std std-id="iso:std:iso:13408:en" type="undated"><std-ref>ISO 13408</std-ref></std> 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.</p></sec><sec id="sec_1.2"><label>1.2</label><p>This part of <std std-id="iso:std:iso:13408:en" type="undated"><std-ref>ISO 13408</std-ref></std> 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 <std std-id="iso:std:iso:13408:en" type="undated"><std-ref>ISO 13408</std-ref></std>.</p><non-normative-note><label>NOTE</label><p>This part of <std std-id="iso:std:iso:13408:en" type="undated"><std-ref>ISO 13408</std-ref></std> 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.</p></non-normative-note></sec>
Adopted: 2008-06-10
ICS: 11.080.01 - Sterilisering og desinfeksjon. Generelt