Many quality consultants will send you a one-page "ISO 15378 Gap Analysis Checklist" in PDF for free if you fill out a lead form. Use a disposable email address if privacy is a concern.
If you want, I can:
(Invoking related search terms...)
ISO 15378:2017 is the international standard that defines the Quality Management System (QMS) for manufacturers of primary packaging materials iso 15378 key pointspdf free
for medicinal products. It integrates the broad management principles of ISO 9001:2015 with the rigorous Good Manufacturing Practices (GMP) required for pharmaceuticals. Pacific Certifications Core Key Points of ISO 15378
The ISO 15378 standard specifies requirements for a Quality Management System (QMS) specifically for manufacturers of primary packaging materials for medicinal products. It integrates the broad management principles of ISO 9001:2015 with the stringent requirements of Good Manufacturing Practice (GMP). Key Points of ISO 15378:2017 ISO 15378-2017.pdf
Any process affecting product quality must be validated. Common examples: Many quality consultants will send you a one-page
Primary packaging touches the drug. Therefore, ISO 15378 specifies strict limits for:
The most unique feature of ISO 15378 is merging ISO 9001:2015’s process approach with GMP principles (as described in ICH Q7 and 21 CFR Part 210/211). This means:
If you change a raw material supplier or manufacturing process, you must: If you want, I can:
To solidify your understanding, here is a quick comparison table:
| Feature | ISO 9001:2015 | ISO 13485:2016 | ISO 15378:2017 | | :--- | :--- | :--- | :--- | | Focus | General industry | Medical devices | Primary pharma packaging | | GMP Reference | No | Partial (Device GMP) | Full (ICH Q7, EU GMP) | | Cleanroom Required | No | Sometimes | Yes (for sterile contact) | | Extractables/Leachables | No | No | Mandatory | | Typical Auditor | Commercial CB | Regulatory CB | GMP + CB dual qualified |
If you are downloading a “key points PDF” to study for an audit or implementation, here are the five pillars you must focus on.