Primary Packaging Materials for Medicinal Products (ISO 15378) Certification

ISO 15378 is a quality management system standard for organisations manufacturing primary packaging materials for medicinal products. It builds on ISO 9001 and adds Good Manufacturing Practice (GMP) requirements on top. Primary packaging is packaging in direct contact with the medicine: glass bottles, rubber stoppers, blister foil, syringe barrels, and the like.

• Organisations manufacturing glass bottles, ampoules and vials for the pharmaceutical sector
• Manufacturers of rubber stoppers, caps and seals
• Manufacturers of blister foil and laminate packaging
• Manufacturers of plastic syringes, droppers and closed-system components
• Packaging firms within scope of pharmaceutical manufacturers' supplier-approval process

Not legally mandatory; the requirement comes from the customer. Because pharmaceutical manufacturers are obliged to audit their suppliers under GMP, an ISO 15378 certificate is widely requested in supplier approval because it reduces this audit burden.

• The entire ISO 9001 structure (clauses 4-10) forms the basis
• GMP requirements: contamination and cross-contamination control
• Cleanroom, hygiene and personnel-conduct rules
• Process validation and change control
• Traceability and batch records
• Risk management and identification of critical process parameters
• Verification, deviation management, and complaint/recall processes

1. 1ApplicationThe organisation's field of activity, headcount, number of sites and scope boundaries are determined. The number of audit days is calculated from this information.
2. 2Document Review (Stage 1)The management system documentation, scope definition, risk assessment and internal-audit/management-review records are examined; readiness for the on-site audit is assessed.
3. 3Certification Audit (Stage 2)It is verified on site that the system is implemented and effective. Findings are classified as major/minor nonconformity or observation.
4. 4Closing NonconformitiesThe organisation submits a root-cause analysis and corrective action plan. The certificate is not issued until major nonconformities are closed.
5. 5Issuing the CertificateThe certificate is issued after review by an independent decision-maker. The audit team cannot make the certification decision.
6. 6Surveillance AuditsA surveillance audit is carried out at least once a year during the certificate's validity. The first surveillance cannot exceed 12 months from the last day of Stage 2.
7. 7RecertificationAt the end of three years, the entire system is re-audited; it must be completed before the certificate expires.

Management system certificates are valid for three years. At least one surveillance audit is carried out per year during this period; the certificate is suspended if surveillance is not carried out. A recertification audit is completed at the end of the third year.

• Trade registry record and operating licence
• The organisation's organisation chart and headcount
• The list of sites/branches within scope
• The management system manual or process documentation
• Internal audit and management review records
• Legal permits, licences and operating documents, if any

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The headcount within scope (directly determines the number of audit days)
• The number of sites and branches; whether multi-site sampling applies
• The activity's risk level and process complexity
• The number of standards to be certified — an integrated audit reduces the number of days
• The three-year cycle: certification + two surveillance audits

Management system certification is carried out within the scope of ISO/IEC 17021-1. The certification body is accredited by an accreditation body party to the IAF multilateral recognition agreement (IAF MLA); This agreement establishes a chain of international recognition that ensures that a document issued in one country is accepted in other countries. EUROLAB has internationally recognized accreditation from IAF member accreditation bodies within the scope of ISO/IEC 17021-1.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• ISO 9001Quality Management System
• ISO 10002Customer Satisfaction and Complaint Management
• ISO 10004Customer Satisfaction Monitoring and Measurement
• ISO 10012Measurement Management System
• ISO 13485Medical Device Quality Management
• ISO 17034Reference Material Producers
• ISO/IEC 17025Testing and Calibration Laboratories
• ISO 21001Educational Organizations Management