Industry Implications of Pharmaceutical Quality ICH Guidelines
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1 EIPG General Assembly Industry Implications of Pharmaceutical Quality ICH Guidelines 20 th April 2008
2 Pharmaceutical Quality Develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science. Q8: Pharmaceutical Development Q9: Quality Risk Management Q10: Pharmaceutical Quality System
3 Pharmaceutical Development. The aim of pharmaceutical development is to design a product and its manufacturing process to consistently deliver the product conforming to the intended performance. The information and knowledge gained in the pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space (QbD), specifications and manufacturing controls.
4 ICH Guidelines Pharmaceutical Development continued To achieve the desired state; Product quality and performance should be achieved and assured by design of effective/robust manufacturing processes. Product specifications should be based on mechanistic understanding of how formulation and process factors impact on product performance, Product quality and performance linked to clinical safety and efficacy.
5 ICH Guidelines- Quality Risk Management To provide the principals and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality in development, manufacturing, distribution and inspection.
6 Principals of Quality Risk Management Foundation for science based decisions when integrated t in to quality management systems. Can facilitate better and more informed decisions Can provide regulators with greater assurance of companies ability. Can facilitate better use of resources.
7 Quality Management System. All licensed medicines must be manufactured so as to ensure that they are fit for the intended use and do NOT place patients at risk due to inadequate safety, quality or efficacy. To achieve the quality objectives their must be a comprehensive QMS incorporating Good Manufacturing Practice and Quality Control. There are additional legal responsibilities for the designated Qualified Persons (QP) to control the release of products compliant with MA.
8 Pharmaceutical Quality system: Introduction 1. ICH Q10 describes a comprehensive approach to an effective pharmaceutical quality system for the pharmaceutical industry 2. It is based on ISO concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk Management 3. It can be implemented throughout the different stages of a product lifecycle.
9 Q10 implementation status Transmission to CHMP and to Interested Parties May Issued as EMEA/CHMP/ICH/214732/2007. Deadline for comments: November 2007 Comments will be discussed in an ICH meeting in Spring 2008 with the goal to reach step 4. Step 2 of the document reached during ICH meeting in Brussels (5-10 May 2007)
10 Definition of Product life cycle Development -API development -- Excipient development (where relevant) -- Formulation development (incl. Container / closure system) - Manufacturing process development Technology Transfer Manufacturing -Procurements of materials - Production (incl. packaging and labelling) - Quality control - Release - Storage - Distribution Product Discontinuation
11 Composition of the document The document is divided in 5 sections and one annex 1. The Pharmaceutical Quality System 2. Management responsibility 3. Continual improvement of process performance and product quality 4. Continual improvement of the pharmaceutical quality system 5. Glossary 6. Annex 1 concerning potential opportunities to enhance science and risk based regulatory approaches
12 Composition of the document 1. The Pharmaceutical Quality System :Scope This guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the differences among, and the different goals of each stage.
13 Composition of the document 1.The Pharmaceutical Quality System : scope For the purposes of this guideline, the product lifecycle includes the following technical activities i i for new and existing i products : Pharmaceutical development Technology transfer Manufacturing Product discontinuation
14 Composition of the document 1.The Pharmaceutical Quality System : scope ICH Q10 Objectives Achieve product realisation Establish and maintain a state of control Facilitate continual improvement
15 Composition of the document 1.The Pharmaceutical Quality System : scope Two enablers have been mentioned in this document (knowledge management and quality risk management) that facilitate a consistent scientific approach to achieve the objectives of Q10.
16 Composition of the document 2.Management responsibility : key elements This part of the document is really based on ISO norms (series 9000) and describes : Management commitment Quality ypolicy Quality planning Resource management Internal communication Management review Oversight of outsourced activities
17 Composition of the document 3. Continual improvement of process performance and product quality : key elements This section describes, for each of these 4 elements, what can be done for each step of the product lifecycle, notably through tables.
18 Knowledge Management-Monitoring Development Technology Transfer Manufacturing Product Discontinuation Can be utilised to identify critical process parameters and critical quality attributes Confirms the suitability of the process and the successful transfer into manufacturing Should be applied Knowledge gained to be incorporated into the knowledge management system Output should be an input to each of the other PQS elements Measurement of the process ceases Monitoring of e.g. stability studies continues Where warranted action on marketed products must still be executed
19 Composition of the document 4.Continual improvement of the pharmaceutical quality system This section describes activities that should be conducted to manage and continually improve the pharmaceutical quality system.
20 Continual improvement of process performance Pi Principal i components of PQS : Process performance and product quality monitoring system Corrective Action and Preventive Action System (CAPA) Change management system Management review of process performance and product quality
21 Composition of the document 5 Glossary This section provides definition used into ICH Q10 ICH and ISO definitions are used where they exist Where no ICH or ISO definition was available, an ICH Q10 definition was developed
22 Composition of the document 5 Glossary Pharmaceutical Quality System : management system to direct and control a pharmaceutical company with regard to quality. (ICH Q10 EWG based upon ISO ) Control strategy : a planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. (ICH Q10 EWG)
23 Composition of the document 5 Glossary Enabler : a tool or process which provides the means to achieve an objective. (ICH Q10 EWG) State of control : a condition in which the set of controls consistently provides assurance of continued process performance and product quality. (ICH Q10 EWG) Senior management : person (s) who direct and control a company or site at the highest levels. (ICH Q10 EWG based on ISO definition for Top Management )
24 Composition of the document 6 Annex 1 concerning potential opportunities to enhance science and risk based regulatory approaches This section describes 4 different scenarios considering implementation or not of ICH Q8, Q9 and Q10 documents and envisages potential opportunities which could occur The actual regulatory process will be determined by region
25 ICH Q10 Pharmaceutical Development Technology Transfer Manufacturing ICH Q10 Discontinuation PQS éléments Management Responsibilities Process Performance & Product Quality monitoring CAPA Change Management Management review Enablers Knowledge Management Quality risk Management From Georges France GMP
26 Conclusion This document is one model for implementing a PQS throughout the different stages of a product lifecycle. Implementation of Q10 as described in annex 1 should conduct to potential opportunities This document is product related and not system related Which is different from current GMP And complicates the understanding of the document
27 Conclusion This document facilitates the implementation of ICH Q8 and Q9 but can be used dindependently d from them It could be used only for one (or more) step(s) of the product lifecycle l When implemented, the effectiveness of the pharmaceutical quality system can normally be confirmed during a regulatory inspection
28 Quality Management systems-scope The Regulatory system Quality system Quality Risk Management (Q9) Management Quality Risk Management Pharmaceutical development Pharmaceutical Development (Q8) Existing Existing GMP GMP s Quality System (Q10)
29 Thank you for your attention Any Questions
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