# Presentation: 101156

## A Drug Quality System for the 21st CenturyBreakout Session:Risk-Based cGMPs:  Defining Risk and Quality

**Summary of Stakeholder Comments**
**compiled by****Edward Kaminski, Ph.D.,****Wyeth Pharmaceuticals**
**April 24, 2003**

## Definition of Risk

**No consensus reached**
**FDA and industry do perform risk assessments routinely but few employ a formalized risk assessment and management process**
**Definition may need to be product specific**
**Risk changes through product life cycle**
**Types of risks identified include:**
**Patient**
**Business**
**Regulatory**

## Points to Consider in Defining Risk

**Benefits comparison**
**Product availability**
**Quality systems**
**Product development knowledge**
**Probability and severity of hazard**
**Acceptable levels of risk**
**Patient population (age, condition, species)**
**Number of products made at a given site**
**Exposure (volume of products in commerce)**
**Dosage form**
**Process step**

## Definition of Quality in the Context of Mfg & Control of Products

**Fitness for intended use**
**Safe**
**Effective **
**Available**
**Consistency**
**Process**
**Product**
**Increased process and product knowledge leads to increased assurance of quality**
**Must include customer (patient) expectations**

## Benefits of a Risk Based System

**Patients**
**Increased availability**
**Faster approval of new products**
**Continue to receive quality products**
** ****FDA**
**More product and process knowledge shared by industry**
**More efficient resource allocation for review and inspection**
**Increased trust and understanding of industry decision making**

## Benefits of a Risk Based System

**Industry**
**Fewer, more efficient, science based inspections resulting in increased consistency**
**Faster, more consistent reviews****	**
**Potential for reduced regulatory burden**
**Manage changes and nonconformance with less FDA oversight**
**Focuses resources on critical issues**
**Flexibility to focus on what should be done, not what can be done**
**Improves communication with FDA**

## Challenges

**Major cultural change for both FDA and industry**
**Trust**
**Who will make the first move to drive this process**

## Challenges

**Developing a common understanding of risk and risk assessment**
**Principles and minimum standards**
**Risk assessment and management training **
**Communication to and perception by other stakeholders (public, Congress)**
**Communication within FDA**
**Completion of master plan (timeline)**
**Perceived risk of development report review**

## Existing systems

**Medical devices **
**Foods (HACCP)**
**EPA**
**Insurance industry**
**Well characterized biologics**
**EU and HealthCanada initiatives**
**Deviation reports**
**Annual product review**
**Recall, field alerts**
**Change control**

## Sector Specific Issues

**Different cGMPs for animal products**
**Differences for animals in the food chain**
**Lot release of certain biologics**

## Next Steps

**Evaluate existing systems to develop general principles of risk management**
**Additional work required to define risk and quality in the context of risk based GMPs**
**Complete and share master plan**
**Global harmonization **
**Increasing self regulation**