Aseptic Processing ISO 13485 § 6.3 & 7.5.2 (Executive Series #87) скачать в хорошем качестве

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

Links • GHTF Quality Management Systems - Process Validation Guidance: http://www.imdrf.org/docs/ghtf/final/... • 21 CFR 820.75: https://www.accessdata.fda.gov/script... • ISO 13485:2016: https://www.iso.org/standard/59752.html • Medical Device Single Audit Program (MDSAP) Audit Approach: https://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: https://www.fda.gov/drugs/guidances-d... • ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration: https://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: https://www.iso.org/standard/53393.html • ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements: https://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