ICH Q10

ICH Q10 guideline for pharmacutical industry.

1. ICH Q10: PHARMACEUTICAL QUALITY SYSTEM Md. Abu Naim Shekh Executive , Quality Assurance Navana Pharmaceuticals Limited ICH Q10

2. ICH is the short form of “International Council for Harmonization” of technical requirements for registration of pharmaceuticals for human use. The objective of ICH is to increase international harmonization of technical requirements to ensure that safe, effective and high quality medicines are developed and registered in the most efficient and cost effective manner. Members of ICH: Japan , Europe and USA Meeting are conducted twice in year. Head quarter: Geneva ICH Q10

3. Q1A: Stability testing for new drug substances and products Q1B: Photo stability testing for new drug substances and products Q2: Validation of analytical procedure – text and methodology Q3A: Impurities in new drug products Q4B: Evaluation and recommendation of pharmaceutical texts for use in the ICH region on residue and ignition. Q5A: Viral safety evaluation of biotechnology products. Q6A: Test procedures and acceptance criteria for new drug substances and new drug products. Q6B: Test procedures and acceptance criteria for biotechnology/ biological products . Q7: GMP guide for API Q8: Pharmaceutical guideline Q9: Quality risk management Q10: Pharmaceutical quality system KEY POINTS OF ICH GUIDELINE Q10

4. ICH Q10 PHARMACEUTICAL QUALITY SYSTEM ICH Q10

5. This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. This guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 was adopted in the year 2008 to established and implement an effective QA system in order to comply with GMP. BACKGROUND Q10

6. ICH Q10 describing a model for an effective pharmaceutical quality management system for the pharmaceutical industry. This guideline is based on ISO quality concepts, includes applicable for GMP regulations. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently , the content of ICH Q10 that is additional to current regional GMP requirements is optional. INTRODUCTION Q10

7. The Q10 model should have three main objectives that enhance regional GMP requirements: Achieve product realization Establish and maintain a state of control Facilitate continual improvement Achieve product realization To establish, implement, and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients and other stake holders (health care professionals, regulatory authorities and other internal and external customers) OBJECTIVES Q10

8. Establish and maintain a state of control 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. Facilitate continual improvement To identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations, and pharmaceutical quality system enhancements, thereby increasing the ability to fulfill quality needs consistently. Quality risk management can be useful for identifying and prioritizing areas for continual improvement. OBJECTIVES… Q10

9. 1. Pharmaceutical development Drug substance development Formulation development (including container/closure system) Manufacture of investigational products Delivery system development Manufacturing process development and scale-up Analytical method development 2. Technology transfer New product transfers during Development through Manufacturing Transfers within or between manufacturing and testing sites for marketed products SCOPE Q10

10. 3. Commercial manufacturing Acquisition and control of materials Provision of facilities, utilities, and equipment Production (including packaging and labeling) Quality control and assurance Release Storage Distribution (excluding wholesaler activities ) 4. Product discontinuation Retention of documentation Sample retention Continued product assessment and reporting SCOPE… Q10

11. 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. ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements. RELATIONSHIP OF ICH Q10 TO REGIONAL GMP REQUIREMENTS, ISO STANDARDS AND ICH Q7 Q10

12. Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and process understanding. the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site. Regulatory processes will be determined by region . RELATIONSHIP OF ICH Q10 TO REGULATORY APPROACHES Q10

13. The Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: Process performance and product quality monitoring system Corrective action and preventive action (CAPA) system Change management system Management review of process performance and product quality PHARMACEUTICAL QUALITY SYSTEM ELEMENTS Q10

14. This section describes activities that should be conducted to manage and continually improve the pharmaceutical quality system . Management review of the pharmaceutical quality system. Monitoring of internal and external factors impacting the pharmaceutical quality system. Outcomes of management review and monitoring. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM Q10

15. ICH Q10 is an ISO systems approach to GMP. It is not additional to GMP but integral to GMP. Covers full life cycle of a product. Its main objectives are product realization, control and improvement. Demands management team to lead quality system which protects public health in respect of product life cycle. CONCLUSION Q10

16. International C onference on Harmonization, ICH Q10: Pharmaceutical Q uality System, May 2007 & June 2008. Guidance for Industry: Quality Systems Approach to Pharmaceutical GMP Regulations, September 2006. REFERENCES Q10