Workshop C Pharmaceutical Quality System PQS

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Kuala Lumpur, July 2010. Disclaimer. The information within this presentation is based on the ICH Q-IWG members expertise and experience, and represents the views of the ICH Q-IWG members for the purposes of a training workshop.. Kuala Lumpur, July 2010. Introduction. Structure of this session P

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Workshop C Pharmaceutical Quality System PQS

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1. Workshop C Pharmaceutical Quality System (PQS)

2. Kuala Lumpur, July 2010 Disclaimer The information within this presentation is based on the ICH Q-IWG members expertise and experience, and represents the views of the ICH Q-IWG members for the purposes of a training workshop.

3. Kuala Lumpur, July 2010 Introduction Structure of this session Presentation of key messages on Pharmaceutical Quality System Examples from the Case Study Discussion in one or more sub groups on the key questions Wrap up Breakout report

4. Kuala Lumpur, July 2010 Key message on Pharmaceutical Quality System as proposed by ICH Q10 Building quality into the product during development is fundamental. ICH Q10 is one model of a PQS which reinforces and introduces some elements beyond GMP No intent in ICH Q10 to create new expectations beyond current regulatory requirements Introduces the involvement and role of senior management Introduces a product life cycle perspective Implementation of PQS should provide enhanced assurance of quality Quality Risk Management principles are essential to build an accurate PQS along the lifecycle of a product Knowledge Management and PQS are interrelated PQS approach applies to Drug Substance/ Active Pharmaceutical Ingredient (small molecule & biotech) and Drug Product/ Medicinal Product/ Pharmaceutical Product First comment : I think it is the first time it is mentioned in a guideline and for being coherent with slide 5 Second comment : I am still not comfortable with this sentence. Looking at ISO norms, you never will see QRM principles as part of a QMS First comment : I think it is the first time it is mentioned in a guideline and for being coherent with slide 5 Second comment : I am still not comfortable with this sentence. Looking at ISO norms, you never will see QRM principles as part of a QMS

5. Kuala Lumpur, July 2010 What is ICH Q10? ICH Q10 is a guideline on the essential elements of a PQS through out the life cycle of a product GMP is applicable to the Manufacturing part of the life cycle Manufacturing of Investigational (medicinal) Product Manufacturing of commercial products A ICH Q10 type PQS reinforces/introduces some elements e.g. Link manufacturing and development (incl. feedback) Continual improvement Involvement of senior management Quality Risk and Knowledge management Product Transfer and discontinuation Management of Outsourcing and purchasing material

6. Kuala Lumpur, July 2010 Introduces the involvement and role of senior management The decision to have enhanced development approaches (QbD) reinforces the need for a strong link between quality systems in development and manufacturing Senior management demonstrate commitment to the PQS by : Granting adequate resources to implement, support and manage the PQS Communicating the importance of the PQS Ensuring strong interfaces between all relevant functions e.g. Development, manufacturing, Quality Unit (QA, QC, QP), engineering, supply chain and management of outsourced activities Participation in the system through the conduct of management review (including process performance) of the PQS and product quality review Management review et product quality review are really two different “things”.Management review et product quality review are really two different “things”.

7. Kuala Lumpur, July 2010 Introduces a life cycle perspective

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