PS 9000:2001 Pharmaceutical Packaging Materials

Pharmaceutical Packaging Materials Standard, ISO Standards, ISO Certification Ireland

What is PS 9000:2016?

PS 9000 is an application standard developed by the Pharmaceutical Quality Group for the manufacture of pharmaceutical packaging materials. The quality of packaging materials is a critical factor in assuring the safety and efficiency of medicines. The PS 9000 standard establishes a baseline of GMP applicable for suppliers to the manufacturing industry. This standard enables pharmaceutical manufacturers and assemblers to ensure that the packaging materials that they use are of appropriate quality. Not only is this in the interest of patient safety, but also in the pharmaceutical industry where the increasing use of automated packaging processes relies heavily on the consistent quality of packaging components. PS 9000 focuses on the development and implementation, by suppliers, of a quality management system designed to provide assurance of the quality of their products and to enhance customer satisfaction

Who Does PS 9000 Apply To?

This standard applies to quality, technical, research & development, manufacturing and procurement personnel from suppliers and the pharmaceutical industry. Suppliers can include primary, secondary, printed materials and artwork origination.

Benefits of PS 9000

  • Improves your business performance
  • Complies with legislation
  • Ensures quality of packaging materials
  • Ensures patient safety
  • Enhances customer satisfaction
  • Applicable to any organisation, large or small.
  • Improves public image, enhances reputation and improves brand image.
  • Increases profitability
  • Improves staff motivation

QMS Solutions services

We provide full systems support at all stages of development. Services include:

  • Completion of an initial assessment and gap analysis
  • The preparation of all required systems documentation
    Note: systems requirements may be addressed via digital / automated systems.
  • Training and mentoring throughout systems development
  • Completion of internal audit as a pre-requisite to certification
  • Support with the completion of the annual management review as a pre-requisite to certification

Steps to Certification

QMS Solutions will complete the application for certification and liaise with the certification body to ensure a successful outcome.