Organizations must establish a fully documented QMS. This requires a defined Quality Manual outlining the scope of operations, control of documented information, and comprehensive records retention policies. Clause 5: Management Responsibility
ISO 15378:2017 defines the specifically for manufacturers of primary packaging (vials, stoppers, seals, etc.) that come into direct contact with medicinal products . 🛠️ Core Integration The standard is a hybrid that combines: iso 15378 key pointspdf free
Documented line clearance records completed before starting any new manufacturing run Organizations must establish a fully documented QMS