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
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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
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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
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7. The Q10 model should have three main objectives that enhance
regional GMP requirements:
1. Achieve product realization
2. Establish and maintain a state of control
3. Facilitate continual improvement
1. 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
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8. 2. 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.
3. 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…
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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
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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…
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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
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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
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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:
1. Process performance and product quality monitoring system
2. Corrective action and preventive action (CAPA) system
3. Change management system
4. Management review of process performance and product
quality
PHARMACEUTICAL QUALITY SYSTEM ELEMENTS
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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
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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
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16.  International Conference on Harmonization, ICH Q10:
Pharmaceutical Quality System, May 2007 & June 2008.
 Guidance for Industry: Quality Systems Approach to
Pharmaceutical GMP Regulations, September 2006.
REFERENCES
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