Aseptic Processing ISO 13485 § 6.3 & 7.5.2 (Executive Series #87)

Links
• GHTF Quality Management Systems - Process Validation Guidance: www.imdrf.org/docs/ghtf/final/...
• 21 CFR 820.75: www.accessdata.fda.gov/script...
• ISO 13485:2016: www.iso.org/standard/59752.html
• Medical Device Single Audit Program (MDSAP) Audit Approach: www.fda.gov/media/87544/download
o Chapter 3: Task 7
o Chapter 6: Tasks 5, 7, 8, 9, 11, 13 & 15
• Questions and Answers on Current Good Manufacturing Practices-Production and Process Controls: www.fda.gov/drugs/guidances-d...
• ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration: www.iso.org/standard/53394.html
• ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration: www.iso.org/standard/53393.html
• ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements: www.iso.org/standard/37842.html
Requirement name and location
Our topic, aseptic processing, comes directly ISO 13485 § 6.3 and 7.5.2. There is also a standalone ISO document. 13408 Aseptic processing of health care products. There are other supporting ISO documents as well.
Aseptic Processing in 5 words:
Product remains sterile throughout Manufacturing

[@Hash849]

Nice video thank you. Short but very helpful

[@QualitySystemsExplained]

I am happy you found it helpful! :)