Significance
Since being released in 2006, ISO 15378 has become increasingly significant for manufacturers of primary packaging materials for medicinal products. It includes a number of legal requirements from AMG; AMWHV (Medical Products Act, Germany) and FDA for Manufacturers of Medical Devices.
ISO 15378 offers precise requirements for suppliers of primary packaging materials for medicinal products because all “GMP” requirements are included. The standard is process oriented and includes sector specific requirements in addition to those of ISO 9001 for quality management systems. In state-of-the-art manner, ISO 15378 offers the opportunity to mutually set GMP and quality requirements.
In addition to ISO 9001:2000 requirements manufacturers of primary packaging materials need to meet further criteria like batch traceability, risk management, validations and controlled area conditions. Until now there had not been a checklist with questions that would describe quality relevant GMP requirements to inspect and clear such manufacturers in terms of supplier qualification. ISO 15378 meets those requirements and helps to ensure and improve reputation and loyalty of customers and public administration.
The benefits
- Proven compliance with legal regulations and contractual agreements (especially by implementing GMP requirements
- Risks are being controlled and minimized
- Emphasizes a company’s competence
- Clear competitive advantage
- Improves performance quality
- Saves time and costs
ISO 15378 – Who does it apply to?
ISO 15378 applies to manufacturers of primary packaging materials for medicinal products. The standard covers all common materials of primary packaging materials like glas, rubber, aluminium and plastic. In addition to strong international acceptance ISO 15378 helps all subcontractors who produce those materials or those who directly pack them to reach a high GMP (Good Manufacturing Practise) level. For suppliers of primary packaging materials for pharmaceutical products the standard includes all relevant GMP requirements and allows the compliance with International, European and National guidelines.
