Packaging Material Audits

The EU-GMP Guide Part I stipulates that the selecting, qualification, approval and retention of suppliers of primary and printed packaging materials should be given similar attention as that of suppliers of raw materials. Manufacturers of pharmaceutical packaging materials typically have ISO 9001 and/or ISO 15378 certification. However, such certificates do not replace customer audits. Contaminated or defect packaging materials of medicinal products can lead to serious risks. Due to the high criticality of packaging materials (especially primary packaging materials, sterile packaging materials, and printed packaging materials) audits are an essential part of supplier qualification to ensure compliance with applicable GMP requirements. The holder of the manufacturing authorisation can verify such compliance either by himself or through an entity acting on his behalf. blue offers risk-based audits of all types of packaging material suppliers, including sterile packaging materials. Auditors of blue inspection body are trained on relevant requirements (ISO and GMP) on a regular basis. Only audits performed by trained and experienced auditors can significantly reduce the risk related to packaging materials for medicinal products.