ich Q10 pharmaceutical quality system.pptx

Pharmaceutical quality system is a topic of quality assurance it is a complete document regarding ICH Q10 guidelines

1. Pharmaceutical Quality system Rani Kasar Assistant professor Gracious college of pharmacy

2. Guideline ICH Q10 is named as pharmaceutical quality system The object is to provide pharmaceutical manufacturers a model for effective quality management system. Pharmaceutical quality system is a management system that controls and directs a pharmaceutical company on matters related to the quality of pharmaceuticals This system can be implemented at any stage of the product life cycle. Implementation of this guideline throughout the life-cycle of a product facilitates innovation and continuous improvement in the process involved in pharmaceutical development and manufacture. Most of the elements that have been described under ICH Q10 are already present in the regional GMP regulatory requirements and hence this model is required to be used along with the latter. Need for Pharmaceutical Quality System

3. Need for Pharmaceutical Quality System systems that are involved in the development and manufacture of APIs drug products, biotechnology and biological products and can be implemented throughout the product life-cycle. The principles of ICH Q10 should be applied such that they are suitable and proportionate to each stage of the product life-cycle by identifying the differences between each stage and different goals of each stage. The product life-cycle with respect to new and existing products includes the following technical activities which are required to be controlled for achieving a quality product. 1. Pharmaceutical Development (a) Development of drug substance (b) Development of formulation (c) Manufacture of investigational products

4. ( d ) Development of a suitable delivery system (e) Development of manufacturing process and scale-up 2. Commercial Manufacturing Purchase and control of materials Arrangement of facilities, equipment and utilities Production Quality control and assurance Release, storage, and distribution. 3. Technology Transfer New product transfer during development Transfer within or between manufacturing and testing sites for marketed products. 4. Product Breach (a) Sample and documentation retention (b) Continuous product assessment and reporting

5. Objectives of ICH Q10 The three main objectives of ICH Q10 model are, To develop and maintain an effective monitoring and control system for process performance and product quality. To develop, implement and maintain a system which ensures that quality products are prepared which would meet the requirements of health care professionals, regulatory authorities and patients. 3. To recognize and accomplish required product quality improvements, process modifications, innovations, reduction in variability and pharmaceutical quality system improvements to enhance the ability in maintaining the desired quality at all times.

6. Knowledge and Quality Risk Management Knowledge management- knowledge management is a methodical approach of obtaining, analyzing, storing and communicating information related to manufacturing processes, products and components. Prior knowledge, pharmaceutical development studies, process validation studies, manufacturing experience, innovation, technology transfer activities, innovation and change management activities are some of the examples that serve as the sources of knowledge. Quality Risk Management- It is an integral part of an effective pharmaceutical quality system. It is a systematic method of controlling, communicating, reviewing and assessing the risks to the drug product quality throughout the product life-cycle, thereby facilitating continuous improvement of product quality and process performance.

7. Consideration Related to Design and Content 1 The structure, organization and documentation of the pharmaceutical quality system should be clear and well defined for easy understanding and application. 2. Principles of the quality system should be so designed that they are suitable and proportionate to each and every stage of the product life-cycle by taking into consideration the different goals and the information available for each stage. 3. A new pharmaceutical quality system or modification of an existing system should be developed based on the size and complexity of the company's operations. 4. The system should include suitable processes, resources and responsibilities for giving assurance of the quality of purchased materials and outsourced operations . It should also include product quality and process performance control, corrective and preventive action, change management and management review. Performance indicators and management responsibilities should be identified and monitored for assessing effectiveness of pharmaceutical quality system processes. Suitable risk management principle should also be included in the system.

8. 1 . Quality Manual A quality manual is a document specifying the quality management system of an organization. It should be prepared and is required to contain the following. (a) Quality policy (b) Scope of the pharmaceutical quality system (c) All the processes involved in the pharmaceutical quality system, their linkages, sequences, and interdependencies. (d) Management responsibilities related to the pharmaceutical quality system. 2. Management Responsibility Management Commitment The responsibility of ensuring an effective pharmaceutical quality system ultimately rests in the hands of top management. It is essential to clearly outline the roles and responsibilities and communicate the same to the concerned authority.

9. Following are the responsibilities of the management with respect to the pharmaceutical quality system. 1. It should be involved in the design, maintenance, control and implementation of an effective pharmaceutical quality system. 2. To assign individual roles, responsibilities, authorities and interrelationships of all organizational units that are associated with pharmaceutical quality system. 3. To support the pharmaceutical quality system and ensure that it is fulfilled throughout the organization 4.To review product quality, process performance and the pharmaceutical quality system. 5. To allocate suitable resources and support continual improvement. Quality Policy 1.A quality policy for describing the overall intentions of the company related to quality should be established by the top management.

10. The policy should contain a requirement stating it is necessary to comply with the related regulatory requirements and should facilitate continual improvement of the pharmaceutical quality system. 3. It is necessary to communicate the quality policy to all the employees of the company who should have complete understanding of it. 4. It should be reviewed periodically for maximum effectiveness . Quality Planning 1. It is a part of quality management that fulfills the quality objectives by establishing quality objective and designating required operations and related resources. P-[;’ 2.Quality objectives should comply with the company's strategies and quality policy. 3. They should be assisted by all related levels of the company. Adequate training and resources should be provided by the management for achieving the quality objectives. 5. Performance indicators that measure progress relative to quality objectives should be established, communicated, and controlled.

11. Resource Management 1. Adequate and appropriate resources with respect to equipment, facilities, personnel, financial and materials should be provided by the management for an effective pharmaceutical quality system. 2. It should be ensured that these resources are applied to a specific process, product or site in an appropriate manner . Internal Communication 1. Appropriate communication processes should be established and implemented by the management within the organization. 2. These communication processes should ensure, (a) That the flow of information between all levels of the company are timely highlighted. (b) That the issues related to product quality and pharmaceutical quality system are timely highlighted.

12. Elements of Pharmaceutical Quality System 1. Product Quality and Process Performance Monitoring System A system for monitoring process performance and product quality should be designed and executed by the pharmaceutical companies for producing a product of desired quality and identifying the area's continual improvement. Such system should carryout following activities. (a) Establish a control strategy using quality risk management which includes different parameters and attributes related to drug substance and drug product materials, facility and equipment operating conditions, improcess controls, finished product specifications etc. (b) Analyze the parameters identified in the control strategy to check for continued operation within a controlled state. (c) Provide tools for measuring and analysis of parameters (d) Provide knowledge which would increase design space, process understanding and innovative approaches to process validation. (e) Provide feedback on product quality from external and internal sources.

13. . Corrective and Preventive Action (CAPA) System- Based on the results obtained upon investigation of product rejections, recalls, deviations, audits, regulatory inspections and findings and trends from process performance and product quality monitoring the pharmaceutical company is required to develop a system implementing corrective and preventive actions to ensure that the system is implemented effectively and it improve the process and product quality and increase the knowledge pertaining to product and process. Change Management System- An effective management system aids in approving, evaluating and implementing changes related to innovation, continual improvement, the outputs of product quality and process performance monitoring and CAPA. The change management system helps in attaining continual improvement in a timely and effective manner. It should include the following,(a) Quality risk management should be used to evaluate the proposed changes. The level of effort and compliance of evaluate should be such that it reduces the level of risk..

14. (b) Evaluation of proposed charges should be carried out with respect to design space, marketing authorization and/or current product and process understanding by expert teams from relevant areas.(c) An evaluation of the change should be done following implementation for ensuring that the change objectives were achieved and there was no negative impact on product quality . Management Review of Product Quality and Process Performance Management review refers to a series of reviews carried out at various levels of management. It involves a timely and effective communication process for bringing the quality issues to the notice of top management for review.(a) It should include periodic quality reviews of, Conclusions of product quality and process. Measures of consumer satisfaction like product quality Effectiveness of process and product changes