The CQI's Pharmaceutical Quality Group (PQG) working party has been developing the next generation of the well-established pharmaceutical packaging materials standard PS 9000.
In addition to inputs from pharmaceutical clients and suppliers, the new version has been developed in partnership with the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) taking into account the requirements and guidance for orally inhaled and nasal drug products developed by IPAC-RS.
The objective of the new version has been to review, embrace and adopt a standard, based on the ISO 9000 framework, which delivers a quality management system translation with enhanced additional requirements for good manufacturing practices in the supply of medicinal products together with good practice guidance.
The PQG’s vision is for the complete document to be available in two forms, as a freely downloadable interactive electronic standard and guide and a printable document that can accompany individuals as they assess themselves or their suppliers, through reviews and audits.
Have your say
The PQG’s aim is to obtain input into the draft document, providing an excellent opportunity for enhancement of the final publication. The group is therefore seeking feedback from quality professionals within the pharmaceutical sector on the requirements and guidance contained within the draft publication.
The PQG is strongly encouraging the participation of individuals and businesses within the sector to feedback using the supplied template. Please note the following when providing input onto the template:
- Ensure you provide your business name
- Provide the correct reference to the clause
- Do not alter the column dimensions.
In addition we would also welcome feedback on the following elements of the new standard:
- Overall feel and layout
- Completeness and technical content
- Usability in the industry.
And finally, the PQG wants to know whether you would consider endorsing or recommending the completed standard?
Consultation period
The consultation period will remain open on the draft document until 24 November 2010, which is the deadline for receipt of comments into the working party.
The draft document PS 9000 is now downloadable from the PQG website for the purposes of the consultation.
Please feedback comments on the supplied template to David Abraham at E: dabraham@tagworldwide.com