Pharmaceutical - PS 9000
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Overview of PS 9000
The quality of packaging materials is a critical factor in assuring the safety and efficacy of medicines. The PS 9000 Standard establishes a baseline of GMP applicable for suppliers to the Pharmaceutical industry. As regulations change for the Pharmaceutical industry and their products, also the requirements for all aspects of the supply chain change in order to assure product quality and patient safety.
The CQI’s Pharmaceutical Quality Group in partnership with Pharmaceutical industry, suppliers and IPAC-RS (International Pharmaceutical Aerosol Consortium on Regulation and Science) has developed the next generation of the well established PS 9000:2001 Standard. This latest 2011 version of the Standard (just released on 14 Sep 2011) is based on the ISO 15378 framework, and delivers a quality management system with updated and enhanced additional requirements, together with guidance, reflecting Good Manufacturing Practice in the supply of pharmaceutical packaging materials.
The objective of the 2011 Standard is to provide updated requirements and guidance for all pharmaceutical packaging materials whether primary, secondary, complex or for suppliers of print origination. The updated Standard provides the requirements for supplier certification against the revised requirements and is of use by suppliers to develop and implement an enhanced Quality Management System and for auditors and representatives from the Pharmaceutical industry to audit suppliers or to work with suppliers in developing and implementing enhanced standards of GMP.
PS 9000:2011 is an application standard developed by the PQG for the manufacture of packaging materials for medicinal products and now for orally inhaled medicines. The document defines specific requirements and guidance for GMP integrated with the requirements of ISO 9001, ISO 15378 and IPAC RS.
PS 9000:2011 was updated and revised in September 2011 to include additional requirements particularly for electronic origination of artwork, the requirements of ISO 9001, ISO 15378 and also for packaging materials for Orally Inhaled and Nasal Drug Products.
PS 9004 Pharmaceutical Packaging Materials – A Guide to PS 9000:2001 (which has been replaced by PS 9000:2011).
The guide provides in clear language, the appropriate reason for each critical requirement contained in PS9000:2001 together with details of sources of further useful reference information. The guide is intended primarily to help with the education and training of supplier’s staff but will also be useful for the training of appropriate pharmaceutical industry staff.
Although the standard, which this guide is based on has been superseded, PS 9004 does contain a lot of interesting case studies and explanations which remain valid and are therefore useful background material.
PS 9100:2002 is an application standard developed by the PQG for the manufacture of excipients for medicinal products. This code of practice defines specific requirements and guidance for GMP integrated with ISO 9001.
The Pharmaceutical Quality Group is the longest established of the CQI’s special interest groups, which, since 1977, has met the needs of quality professionals within the pharmaceutical industry by:
- Providing a forum for support for the trainee and newly Qualified Person (QP) and on-going advice and support for all QPs.
- Arranging regular meetings on Quality Assurance, Good Manufacturing Practice and ‘hot-topics’.
- Developing monographs which provide guidance on a range of regulatory requirements.
- Developing GMP Application Standards and guidance for suppliers to the pharmaceutical industry.
- Managing a Certification Scheme for suppliers of materials to the pharmaceutical industry.
- Acting as the focus for regular liaison with representatives of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- Organising co-operative ventures and meetings with several other groups e.g. IPEC, IPAC-RS, with which it shares a common interest.
- Maintaining a ‘Members only’ area on its website which provides much up to date information.
- Facilitating the opportunity to network with colleagues in the pharmaceutical industry enabling our members to improve their knowledge and skills to meet the ever changing requirements of our industry
For further details, see PQG
Benefits of Implementing PS 9000
Certification to the PQG Certified Supplier scheme is given by independent, accredited, certification bodies to suppliers to the pharmaceutical and related industries that meet expected standards. Suppliers certified to the PQG scheme are entitled to use PQG Certified Supplier logos on their company literature, which indicates to the pharmaceutical industry that they conform to the GMP standards expected for suppliers to the industry.
PS 9000 Training Programmes
- Pharmaceutical Packaging Awareness Courses (PS 9000 and PS 9004 based)
- Pharmaceutical Internal Auditor Course
- IRCA Registered Pharmaceutical Auditor/lead Auditor Training Course (IRCA Ref. No. A17128)
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