Certification according to ISO 15378:2006

The primary packaging standard ISO 15378:2006 has been developed specifically for manufacturers of  packaging material for pharmaceutical products. The basis is the internationally recognised norm ISO 9001:2000. Secure a clear competitive advantage as a manufacturer through concrete requirements specific to your industrial sector!

The norm defines requirements for quality management systems for

• design/development
• production  
• customer service and assembly

of primary packaging material for pharmaceutical products. It covers all GMP guidelines (GMP = Good Manufacturing Practice) which are usually applied in the production of primary packaging material. Apart from the imposed requirements of ISO 9001:2000 a series of additional criteria specific to the primary packaging industry must be fulfilled with ISO 15378:2006.

Among these are:

• batch tracing
• controlled environmental conditions
• validations
• risk management

Success in four steps!

1.       Preliminary audit
          Briefing and preliminary assessment through site inspection.

2.       Examination of documents
          Examination whether the quality
          management documentation matches the norm requirements

3.       Certification audit
          Examination of the practical application of your quality
          management system, evaluation of the effectiveness and
          compilation of a report.

4.       Issuing of the certificate
          Completion of certification when all criteria are complied with.
          Attestation of  the norm conformity  and efficiency of the
          quality management system.

Simply speak to us – we are looking forward to hearing from you!