Pharmaceutical Quality Group David Abraham PS 9000:2011 The Manufacturing of Packaging Materials for Medicinal Products Pharmaceutical Quality Group David Abraham

PS 9000:2011 Seminar Topics Introduction to PS 9000 The PS 9000:2011 Interactive Publication Short scenario workshop using the publication

PS 9000:2011 Introduction What is PS 9000 An application standard, which details and set out both Good Manufacturing Practices (GMP) requirements and guidance for the supply and delivery of packaging components. A fully interactive publication incorporating important reference text to assist medicinal product manufactures and their suppliers in understanding of their respective responsibilities in producing components of the requisite quality

PS 9000:2011 Introduction The Objective of PS 9000 Enable the provision of consistently high quality packaging components by promoting the implementation of robust quality systems throughout supply chain Establish confidence in the supply chain, that the products / Services provided are “fit for Purpose” in the delivery Quality, Safety and Efficacy of packaging components To strengthen the supply chain against the threat of counterfeit medicinal product and components Focus and deliver safety, quality and efficacy of packaging components though implementation of applicable GMP principles.

PS 9000:2011 Introduction Benefits: Applicable to any organisation, large or small. Improves your business performance Recognised compliance certification standard Provides product consistency and fit for purpose components for patient safety Establishes confidence in the supply chain for quality of packaging materials Improves regulatory assurance, enhances business reputation and brand image. Facilitates best practice business processes through a clear set of principles Enables each process step to be managed in a controlled manor February 22, 2019

PS 9000:2011 Introduction Deliverables: Quality Diligence - Clear implementation of practices across production process including electronic interfaces to assure fit for purpose quality and minimising counterfeit medicines GMP - Incorporation of specific Good Manufacturing Practice requirements followed assuring quality, safety and efficacy of packaging components. Risk Reduction – Facilitates a risk management approach, with key focus on risk areas associated with packaging operations, effective controls and activities, which ultimately helps to reduce potential product and business issues Compliance & Harmonisation – Enables support of regulatory compliance and identification of appropriate legislation through integration of Regulatory, Quality and GMP requirements

PS 9000:2011 Introduction Regulatory Fit: Over 120 certifications to the PS 9000 scheme have occurred since the scheme began Developed in collaboration with IPAC-RS and acknowledge by the MHRA Certification is achieved through the PQG recognised accredited Certification Bodies February 22, 2019

The PS 9000:2011 Interactive Publication David Abraham

PS 9000 Workshop with Interactive Application Scenarios David Abraham Esme Gibb