Mastering ISO 15378: Key Points for Pharmaceutical Packaging
GMP for packaging requires a cultural shift. ISO 15378 dedicates significant attention to human factors because primary packaging is often handled in cleanrooms.
| Clause | Must-Have Document or Evidence | | :--- | :--- | | | External GMP issues (legal register for pharma packaging) | | 5.1 | Management commitment to GMP (visible quality policy signed by top mgmt) | | 6.1 | Risk assessment for contamination & mix-ups | | 7.1 | Calibration records for instruments (particle counters, micrometers) | | 7.5 | Validated sanitation & pest control logs | | 8.1 | Change control procedure (customer, supplier, internal changes) | | 8.5.1 | Process validation protocol & report | | 8.5.2 | Traceability from raw material batch to finished pack | | 10.2 | CAPA (Corrective and Preventive Action) system for GMP deviations | iso 15378 key pointspdf free
To meet the standard, organizations typically maintain a "Documentation Kit" that includes: Aligned with ISO 9001 and GMP.
Visit . ISO offers a free "scope and preview" section that includes the table of contents and clause 0 (Introduction) – which itself contains many key points. Mastering ISO 15378: Key Points for Pharmaceutical Packaging
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Often publish summaries comparing ISO 9001 to ISO 15378 requirements. This link or copies made by others cannot be deleted
The full official ISO 15378:2017 standard is protected by copyright and is sold by national standards bodies. However, there are several ways to access the content for free for :
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
To prevent particulate and microbiological contamination, the standard mandates tight control over the production environment.