Pharmaceutical Packaging Materials Standard, ISO Standards, ISO Certification Ireland
What is PS 9000:2001?
PS 9000:2001 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 9000:2001 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 9000:2001 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 9000:2001
- 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
Stages to Implementation
Ø See how existing policies and practices align with the requirements of the standard.
Ø Determine the needs of your organisation.
Ø Establish policies and objectives.
Ø Conduct initial review.
Ø Determine necessary processes and responsibilities.
Ø Provide resources to attain objectives.
Ø Establish methods for monitoring and analysis.
Ø Determine key performance indicators.
Ø Establish means to effective operational control.
Ø Review and monitor for continual improvement in efficiency.
QMS Solutions service to you
- QMS Solutions will design, develop, draft and implement your complete management system in consultation with you.
- We will also provide in-house training on all aspects of your new management system, tailored to your specific training needs and business requirements
Steps to Certification
- Following initial quotation, an assessor will review your company’s product, processes, procedures, facilities, work environment and resources.
- Conduct an Initial Review and prepare a current state assessment and gap analysis.
- Develop Draft Policy, Objectives, Plans, Processes, Programme, Procedures and Records as per PS 9000:2001 to include applicable exceptions.
- Review and approve the above documentation with the client, as per agreed project approach.
- Handover / implementation of your Management System
- Provide in-house training where appropriate.
- After a period of 3 months QMS Solutions will review the establishment of the Management System and seek registration were appropriate.
- Follow-up audits and pre-audits are conducted on request in advance of the client’s annual independent audit.