ISO 15378

ISO 15378 – Certification – Primary Packaging Materials for Medicinal Products

ISO 15378 Certification was developed for the Pharmaceutical industry with the primary focus on the Primary Packaging Materials used for packaging the medicines. ISO 15378 serves as the quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products.

Having ISO 15378 Certification in your organization means that you have well managed different types of risks related to the contamination, mistakes, faults and compliance of your processes and QMS as a whole. It helps in enhancing confidence of your customers.

Afnor is a globally recognized leader in the Certification industry and in India ISO 15378 Certification is provided by expert Lead Auditors of Afnor.

Importance of ISO 15378 Certification

Getting ISO 15378 certification from a recognized certification services provider like Afnor India is very important for the support and growth of the Pharma Organizations in India.

Some of the important factors are as follows:

  • ISO 15378 Certificate from Afnor is Globally recognized

  • Industry Expert conduct Audits and Assessment for ISO 15378


ISO 15378 Certification – Why?

  • More efficiency in packaging by following GMP standards

  • Reduce expenditure by reducing waste, manufacturing errors and increasing productivity

  • Opens new market for organizations

  • Reduces risks related to product contamination, mixing and errors and increases product shelf-life

  • Release of quality products to market

  • Enhanced customer satisfaction

  • Organization have competitive advantage over others


ISO 15378 Certification – FOR WHOM

Pharma organizations wanting to systematically manage the packaging process and to manage the risks related to the contamination, mistakes, faults and compliance of your processes.