2014 - Mapping the ICH Q10 Quality System to ICH Q7A, Active Pharmaceutical Ingredients GMP and Part 210-211, Final Dosage GMP

Instructor: Howard T Cooper
Description:
The FDA and other regulatory bodies have attempted to define quality activities, roles, and responsibilities since regulation began. As you know, compliance describes the minimum level of quality required to maintain a state of control. Compliance has focused on documentation of quality activities and less on user/patient needs and requirements. Granted, regulation is needed to help overcome the inertia of human behavior.
Quality, according to ICH Q9 defines quality as the degree to which a set of inherent properties of a product, system, or process fulfills requirements. However, to achieve quality, a quality system is required that implements quality policy and ensures that quality objectives are met. It is this quality system that ICH emphasizes throughout the guidance.
Thankfully, the ICH Q10 Committee has delivered a guidance that defines the scope of quality activities. The fact that ICH Q10 is considered a “guidance” and not a regulation enhances management’s acceptance as an important tool in meeting its own corporate objectives.
The ICH Q10 Quality System Model is very general because it represents the consensus of several regulatory bodies. Therefore, each regulatory body regulation impacted by the ICH Q10 must be correlated to ICH Q10 and vice versa. Sometimes there is no direct correlation so what do you do? How about conflicts? Such issues will be discussed for potential solutions.
Introduction & Overview
What is the difference between compliance and quality?
What’s the relationship between quality and quality system?
What should be the boundaries of the quality system
Quality systems and quality gurus
Comparing quality systems
The FDA’s “Quality Systems Approach”
Industry Practice- A Friend To Quality and Compliance
Mapping ICH-Q10 Key QS References to ICH Q10 & Part 211
Pharmaceutical Quality System
Introduction (1.1)
Scope (1.2)
Relationship with ICH Q-10 8 Quality Manual
MANAGEMENT RESPONSIBILITY
Management Commitment (2.1)
Quality Policy (2.2)
Quality Planning (2.3)
Resource Management(2.4)
Internal Communication (2.5)
Management Review (2.6)
Management of Outsourced Activities & Purchase Materials (2.7)
Management of Change in Product Ownership (2.8)
Continuous Improvement of Process Performance in Product Quality
Lifecycle Stage Goals (3.1)
Pharmaceutical Quality System Elements (3.2)
Process Performance and Product Quality Monitoring System (3.21)
Corrective and Preventive Action (CAPA) (3.22)
Change Management System (3.2.3)
Management Review Of Process Performance and Product Quality (3.2.4)
CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM
Management Review of the Pharmaceutical Quality System (4.1)
Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System in parentheses 4.2)
Outcomes of Management Review and Monitoring (4.3)
Why Should you Attend:
Attendees will gain insight concerning the driving force of management involvement in creating the structure of the quality system. Each of us has a role achieving quality objectives. An understanding of quality systems helps management identify their responsibilities. Less experienced individuals will gain insight about quality systems and, therefore, will become more instrumental in achieving quality and organizational objectives.
By seeing the direct correlation of the ICH Q10 to the regulation, the attendee can better understand and implement the guidance.
Objectives of the Presentation:
The primary objectives of this presentation is:
To assist the implementation of ICH Q10 by correlating directly to the primary regulation
Provide potential answers to conflicts between the regulation and ICH Q10
To analyze the ICH Q10 Quality System Model in order to provide the attendee with information and insight that increases their understanding of the related quality system principles
To explain the workings of the Quality System model so that it may be designed and implemented to be in effective.
Who can Benefit:
Senior Management will become more aware of their responsibilities in the designing, implementing, and management of quality systems.
Quality Organization-Quality management will gain additional insight on how to develop and implement ICH Q10 quality personnel will better understand how the quality system operates as they implement ICH Q10 under direction of management.
Inter-functional groups that are an integral part of quality activities will better understand their roles as it relates to quality.
Pharmaceutical Companies
Contract Research Organizations
Manufacturing and Laboratory contractors to the industry
Medical Device Companies
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