ISO : International Organization for Standardization in Pharmaceuticals : Pharmaguideline

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ISO : International Organization for Standardization in Pharmaceuticals

ISO guidelines for Cleanrooms and associated controlled environments and Bio-contamination Control for Pharmaceuticals.
ISO has covered 18000 standards that are applicable to almost all type of industries but only some of them are used in pharmaceuticals as guidelines for area qualification

Following are the ISO Standards followed by the pharmaceutical industries for non-viable particles in the classified area.
ISO 14644 Standards Cleanrooms and associated controlled environments
ISO 14644-1:1999 Classification of Air Cleanliness
ISO 14644-2:2000 Testing and Monitoring to prove Compliance
ISO 14644-3:2005 Metrology & Test Methods
ISO 14644-4:2001 Design, Construction and Start-up
ISO 14644-5:2004 Operations

ISO 14644-6:2007 Vocabulary
ISO 14644-7:2004 Separative Devices
ISO 14644-8:2006 Classification of Airborne Molecular Contamination
ISO 14644-9 Clean Surfaces
ISO guidelines for viable count in classified area i.e. clean room area.
ISO 14698 Standards
ISO-14698-1 Bio-contamination Control — General Principles
ISO-14698-2 Evaluation & Interpretation of Bio-contamination Data

Also Read:
Complete List of ISO standards
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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2 comments: Post Yours! Read Comment Policy ▼

  1. Is ISO 9001 is applied by pharmaceuticals now? When I was working back in 2004, there was ISO 9001:2000 ;Quality management system

  2. Hi, i am getting ready for ISO 9001:2015 Up gradation, can anyone tell me what should be next issue no. for Manual, as this applicable to new revised standard.either 00 or 01.?


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