ISO 15378:2017 is the internationally recognized standard for Primary Packaging Materials for Medicinal Products. It integrates the principles of Good Manufacturing Practices (GMP) with ISO 9001 to ensure the safety, quality, and regulatory compliance of packaging materials used in the pharmaceutical industry.
Certification under ISO 15378:2017 is suitable for manufacturers of primary packaging materials such as glass, plastic, rubber, aluminum, or laminate used for medicinal products. It demonstrates a strong commitment to product integrity, patient safety, and regulatory compliance.
Purpose of ISO 15378:2017 Certification
- Ensure the safety and quality of pharmaceutical packaging materials
- Integrate GMP principles with quality management requirements
- Prevent contamination, mix-ups, and defects in packaging components
- Comply with global pharmaceutical regulatory expectations
- Strengthen customer confidence and competitive positioning
• Improve traceability, documentation, and operational control
Our ISO 15378:2017 Certification Process
We follow a step-by-step certification process to ensure clarity, objectivity, and transparency:
1. Application Submission
The organization submits a completed Certification Request Form including:
- Company profile
- Number of employees
- Locations of operations
- Scope of certification
2. Application Review & Quotation
We review the details to:
- Verify audit feasibility
- Define the certification scope
- Provide a formal quotation
3. Audit Planning
Once confirmed, we plan the certification audit including:
- Audit team assignment
- Timeline and logistics
- Client coordination
4. Stage 1 Audit – Documentation Review
Assessment of the organization’s QMS documentation for:
- Conformance with ISO 9001:2015
- Readiness for on-site audit
- Identification of potential gaps
5. Stage 2 Audit – On-site Assessment
Comprehensive audit of the implemented QMS:
- Process evaluation
- Staff interviews
- Objective evidence verification
- Identification of nonconformities (if any)
6. Audit Report & Certification Decision
- Audit team submits findings and recommendations
- Independent decision-maker reviews the report
- Certification granted if requirements are met
7. Certification Issuance
- Valid for 3 years
- Certificate includes scope, standard, issue/expiry dates
8. Surveillance Audits (Year 1 & 2)
- Annual on-site surveillance audits
- Verification of continued conformity and improvements
9. Recertification Audit (Year 3)
- Full system reassessment before certificate renewal
Key Features
- ✅ Independent & Impartial GMP-Based Audits
- ✅ Auditors with Pharmaceutical Packaging Expertise
- ✅ Transparent, Process-Oriented Certification Approach
- ✅ Comprehensive, Timely Audit Reports
- ✅ Full Compliance with ISO/IEC 17021-1 and ISO 15378:2017 Requirements
About Quality HUB India
Quality HUB India(QHI) is a NABCB, IAF accredited third-party certification body (CB) offering independent and impartial certification services for a range of ISO management systems. Quality HUB India(QHI) is a trusted name in the field of quality, management system training, and certification support. With a strong focus on empowering organizations to achieve operational excellence. We specialize in ISO 9001:2015 (Quality Management), ISO 14001:2015 (Environmental Management), and ISO 45001:2018 (Occupational Health & Safety Management) certifications.
We follow globally accepted auditing practices in strict compliance with ISO/IEC 17021-1, ensuring fair, transparent, and unbiased assessments across diverse industries and sectors.
How to Get Started
Step 1: Submit the ISO Certification Request Form
Step 2: Our team will contact you for review and audit scheduling.
📞 Contact Us: +91- 7073111630
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