Minimizes the risk of medication contamination or spoilage.
Equipment and processes must consistently produce the desired output.
Robust, documented programs to prevent insects, rodents, or birds from entering facilities. Rigorous Traceability and Documentation
Strict protocols for cleanliness , hygiene, and environmental monitoring (cleanrooms). iso 15378 key pointspdf free
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)
You must maintain full traceability. Key requirements include:
Line clearance, contamination control, traceability, batch records. Ensure product safety and eliminate mix-ups. Internal audits, customer feedback, management review. Measure system health and regulatory alignment. Improvement CAPA system, Root Cause Analysis, continuous refinement. Drive ongoing operational excellence. Minimizes the risk of medication contamination or spoilage
ISO 15378:2017 integrates ISO 9001 quality management with Good Manufacturing Practice (GMP) standards, focusing on the safe production of primary packaging materials for pharmaceuticals. Key requirements include risk management for contamination control, stringent traceability, and process validation to ensure compliance with international regulations. To review the full standard, visit www.iso-vn.com AI responses may include mistakes. Learn more
. This process compares your current quality system against ISO 15378 requirements to identify what needs to be fixed before a final audit. Specialized firms like DQS Global
Rigorous documentation is required to ensure that any change in materials, equipment, or processes is validated and documented to prevent negative effects on the product quality. Benefits of ISO 15378 Certification Ensure product safety and eliminate mix-ups
Unlike generic ISO 9001, ISO 15378 incorporates . If your company produces tubes, blisters, vials, pre-filled syringes, or IV bags, this standard is non-negotiable for regulatory compliance.
The standard is recognized worldwide by regulatory bodies and major pharmaceutical conglomerates, opening doors to lucrative global contracts.
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Improves efficiency and reduces costs associated with product recalls and defects. Where to Find a Summary/PDF of ISO 15378 Key Points