# Presentation: 497908

## Presented at the

**Advisory Committee for Pharmaceutical Science**
**meeting on March 13, 2003**
**by **
**Helen Winkle**

## ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCEMarch 13, 2003

**DRUG PRODUCT QUALITY**
- “Pharmaceutical cGMPs for the 21st Century”

## Goals of Drug Quality Initiative

**Incorporate concepts of risk management and quality systems**
**Include latest scientific advances in manufacturing and technology**
**Better integrate the review program with the inspection program**
**Ensure consistency in standards**
**Encourage for innovation in manufacturing**
**Focus resources effectively to address most significant health risks**

## Overview

**Applies to pharmaceuticals, biological human drugs and veterinary drugs**
**Focus is on review of drug product  applications and inspection of manufacturing facilities**
**Initiative being coordinated through steering committee with members from ORA, CBER, CVM, CDER, OC and input from CDRH and CFSAN**
**Initiative will take two years**
**Already provided six month report - 2/20**

## “Using state-of-the-art approaches to our review and inspection processes means getting important new medications to patients faster...”FDA “...will focus our attention and resources on the areas of greatest risk, with the goal of maximizing public health protection without impeding innovation”     						Mark McClellan, MD

## Task Groups

## Contracts Management

**Expedite external studies of key issues to be addressed under the initiative**
**Looking at two areas**
**Effective Quality Systems Practices**
**cGMP and Other Product Quality Assurance Methodology **
**Other areas of support for initiative**

## International

**Important to have harmonized approaches to assuring drug product quality**
**Work with ICH specifically in the realm of technological advances**
**Look at other forums for harmonization **
**Benchmark with other country systems**

## Part 11

**Clarify the scope of FDA’s electronic recordkeeping requirements**
**Provide for enforcement discretion in the areas where interpretation is unclear**
**Withdrawal draft guidance (2/4)**
**Webcast**
**Amend 21 CFR Part 11 Rule and Preamble**

## Dispute Resolution

**Develop consistent policies and procedures for resolving scientific and technical cGMP issues **
**between regulated industry and the FDA**
**between components within FDA**

## 483 Communications

**Honing language to communicate deficiencies observed during cGMP inspections**
**Combined with Dispute Resolution**

## Warning Letter

**Launching a program to identify any inconsistencies across program areas with respect to all drug cGMP warning letters**

## Manufacturing Science

**Ensure high efficiency and quality of pharmaceutical manufacturing and associated regulatory processes**
**Facilitate introduction of modern manufacturing technologies and systems**
**Enhance FDA expertise in pharmaceutical engineering and technologies**
**PAT initiative **

## Changes Without Prior Review

**Identify opportunities to allow post approval manufacturing changes without FDA review and approval prior to implementation**
**Comparability protocol **
**Discussed yesterday**

## Risk Management Workplanning

**Ensuring systematic risk management approaches**
**Implement risk-based approaches that focus both industry and FDA attention on critical areas**
**Recent reorganization of CDER’s Office of Compliance**

## Pharmaceutical Inspectorate

**Enhance the Agency’s expertise in pharmaceutical technologies**
**Ensure state-of-the-art pharmaceutical science**
**Hire staff that has needed expertise**
**Establish a closer working relationship between field and centers**

## Product Specialist

**Develop highly trained FDA product specialists to help in strengthening consistency in regulatory decisions and ensure submission reviews and cGMP inspections are coordinated and synergistic**

## Team Biologics Operations

**This initiative had already been started**
**Improve operations of Team Biologics building on implementation of quality management system**
**CDER/CBER consolidation will affect how some of Team Biologics is handled**

## Quality Systems

**Looking at both internal and external quality systems**
**Improve both review and inspectional processes through implementing quality systems approach**
**Look at regulation**

## Training

**Affects all areas**
**Still being developed but expect extensive training program both for internal and external**

## Evaluation

**Extremely important part of the initiative**
**Must develop appropriate metrics and mechanism for evaluation of the total initiative**

## Next Steps

**Workshop - April 22-24**
**Possible vetting of manufacturing science questions before advisory committee**
**Several draft guidances to issue for public comment **
** ****Comparability protocol**
** ****Dispute resolution**
**Additional workshops to focus on science ****	**
**Part 11 clarification**