FDA’s Perspective Continued - Where We Are ?

GMP Task Groups

Contracts M anagem entT h e re sa M u llin , C h a ir

K a te M cE vo y, P M

International ActivitiesJa n e t S h o w a lte r, C h a ir

A n a N o rris , P M

Part 11Jo e Fa m ula re , C h a ir

T e rry M a rtin , P M

D isp u te R e so lu tionD a v id H o ro w itz , C o -C h a irH e le n W in kle , C o -C h a ir

M a u ree n H ess , P M

W a rn in g L e tte r R e v iewF re d B lu m e n sche in , C h a ir

E rik H e n rikso n , P M

4 8 3 C o m m un ica tio nsP e te r B e cke rm a n , C o -C h a irD e b b ie R a ls to n , C o-C h a ir

R o se C un n ing h a m , P M

C h a n ge s w /o P rio r R e v iewA ja z H u ssa in , C o -C h a irN a n cy S a g e r, C o -C h a ir

K a thy Jord a n , P M

P ro du c t S p e cia list o n In spe c tion T ea m sA ja z H u ssa in , C h a ir

K a thy Jord a n , P M

W o rk P la nn in g & R isk M an a g em e ntD a v id H o ro w itz , C o -C h a irT h e re sa M u llin , C o -C h a ir

K h ya ti R o b erts , P M

C a d re o f In ves tiga to rsJa n e t W o od co ck, C o -C h a irS u sa n S e tte rb e rg , C o-C h a ir

K h ya ti R o b erts , P M

D e ve lo p S cie n ceA ja z H u ssa in , C h a ir

K a thy Jord a n , P M

T ra in ing

E va lu a tio n o f th e In it ia t iveJa n e t W oo d cock , C h a irT h e re sa M u llin , C h a ir

M a u ree n H ess , P M

Q u a lity S ys te m sJa n e t W oo d cock , C h a ir

L a na P a u ls, P M

Steering Com m itteeJa n e t W oo d cock , C h a ir

M a u ree n H ess , P M

Part 11

• Goal - Change approach to 21 CFR Part 11 - incorporating principles of the cGMPs for the 21st Century

• Guidance to industry

• Amend 21 CFR Part 11 Rule and Preamble

• Narrow interpretation of scope - not cover systems incidental to creating paper records

Manufacturing Science

• Goal - ensure high efficiency and quality of pharmaceutical manufacturing and associated regulatory processes and enhance FDA’s expertise in engineering and technologies

• Workshop - April 2003 - information gathering

• ACPS

Changes without Prior Approval

• Goal - identify opportunities to allow post approval manufacturing changes without FDA review and approval prior to implementation

• Comparability Protocol Guidance

483 Communications

• Goal - determine proper mechanism for communicating deficiencies/inspectional observations to industry

• Additional language on 483s

• Education and training

Warning Letter

• Goal - more scientific review of warning letters before issued and ensuring consistent application of policies and procedures

• New internal process being implemented

Dispute Resolution

• Goal - develop consistent policies and procedures for formally resolving scientific and technical GMP issues and improve transparency of such procedures

• Development of guidance

• 12 month pilot

Risk Management

• Goal - ensure that systematic risk management approaches are applied to allocating resources, selecting sites for inspection and determining the scope of GMP programs for human and veterinary drugs

• Discuss at next meeting of Manufacturing Subcommittee

Pharmaceutical Inspectorate

• Goal - Establish a staff of highly trained inspectors who will spent majority of time doing drug inspections on high risk firms and have close working relationship with Centers

• Working on expert PD and agreement between Centers and Field

Product Specialist

• Goal - effective and efficient use of “product specialists” on inspection teams to strengthen consistency and ensure submission reviews and inspections are coordinated and synergistic

• Concept paper

Team Biologics

Already implementing improvements to the Team Biologics program including: Adopting an internal quality management system Developing metrics to determine the impact of Team

Biologics on the industry Standardizing training and qualifications of the

Core Team members Implementing risk-based work planning Increasing communications between headquarters

and the field

Quality Systems

• External and internal

• Still determining how best to apply internal

• Broader implementation beyond scope of GMP initiative

• Implementation of quality systems approach in how conduct CMC reviews

International

• Goal - internationally harmonized approaches to assure drug product quality and encourage technological innovation

• ICH

• Other venues

Contracts Management

• Goal - expedite external studies of key issues to be addressed by GMP initiative

• Several contracts being researched– Effective quality systems practices - briefings– Benchmarking

Other

• Evaluation

• Training

Next Steps

• Role of Manufacturing Subcommittee

• Obviously, numerous activities which subcommittee can support

• Begin to prioritize

• Help in recognition of other areas to consider