What ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) requires
This standard specifies Good Manufacturing Practice (GMP) requirements for the quality management system (QMS) of manufacturers of primary packaging materials for medicinal products. It integrates ISO 9001:2015 with GMP principles to mitigate risks to patient safety, focusing on contamination control, process validation, and batch traceability as detailed in Clauses 8.5.2 and 8.5.5.
Pillar: Medical & Healthcare · Authority: International Organization for Standardization (ISO) · Version: 1.0.0 · Last updated:
Primary source: https://www.iso.org/standard/70729.html
SHA-256 integrity: 5f0118d991da6000abffcbcf74d9cc022022b03c91cce9ace6816ada2ea06580
Primary Citations — 6 traced to source
- ISO 15378:2017, Clause 6.1: Actions to address risks and opportunities
- ISO 15378:2017, Clause 7.1.4: Environment for the operation of processes
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