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Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M compliance.
ICH Q10 provides a harmonized, comprehensive model for an effective pharmaceutical quality management system throughout the product lifecycle, from development to discontinuation. When implemented, the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site.
The purpose of ICH Q10 is to complement ICH Q7 (Good Manufacturing Practice (GMP), ICH Q8 (Pharmaceutical Development), and ICH Q9 (Quality Risk Management (QRM). It covers the entire product lifecycle: pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation.
Regional GMP requirements, the ICH Q7 Guideline, “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, and ISO quality management system guidelines form the foundation for ICH Q10. To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities. ICH Q10 provides a harmonised model for a pharmaceutical quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements.
The regional GMPs do not explicitly address all stages of the product lifecycle (e.g., Development). The quality system elements and management responsibilities described in this guideline are intended to encourage the use of science and risk-based approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle.
As per the guidelines, regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and process understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system.
Implementation of the Q10 model should result in achievement of three main objectives which complement or enhance regional GMP requirements.
The three main objectives of Q10 model are to achieve product realisation, establish and maintain a state of control and facilitate continual improvement.
It aims to establish, implement and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approved regulatory filings) and other internal and external customers.
It also aims to develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems.
The objective is also to identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations and pharmaceutical quality system enhancements, thereby increasing the ability to fulfil quality needs consistently.
Moreover, use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. These enablers will facilitate achievement of the main objectives by providing the means for science and risk based decisions related to product quality.
Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.
Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality.
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