IPACRS Supplier GMP Workshop

1
Control the Supplier

• Jon Clark
• and
• David Cummings
• FDA/CDER/OPS

2
Office of Pharmaceutical Science(OPS)
CDER/OPS
New Drug CMC
Generic CMC
Biotech CMC
Microbiology CMC
Chemistry Manufacturing and Controls (CMC)
3
314.420 Drug Master Files

• to permit the holder to authorize other persons
  to rely on the information to support a
  submission to FDA
• without the holder having to disclose the
  information to the person
• FDA ordinarily neither independently reviews drug
  master files
• nor approves or disapproves submissions to a drug
  master file
• the agency customarily reviews the information
  only in the context of an application

4
A Null Set

• Information that IS needed for Agency review
• And
• Is NOT needed by the customer to perform adequate
  evaluation of the suppliers capability

5
Current Situation

• Temporarily Strong Interaction between FDA and
  Supplier
• Interaction is based on individual experts review
  of DMF and finding of adequacy
• Interaction largely ends at that point
• Weak Supplier - Manufacturer Interaction
• Acceptance of COA Requires Verification of
  Analytical Methods
• Audit NOT Required to get at Quality Systems

6
Desired State

• Customer (Manufacturer) Controlled Relationship
• Includes Assurance of Continued Quality
• Includes Audit Authority of Suppliers QS
• Minimal Regulatory Oversight
• Includes Acceptance of Manufacturer Audit
• In lieu of
• Review of DMF

7
What would go into the application?

• We are looking for ideas on this
• Here are some thoughts
• Copy of ASQ or ISO certification for supplier
• Copy of manufacturers audit plan and reference to
  the standard it is based on
• Specification
• Attributes that are to be met
• Method by which they are measured
• Criteria for them

8
Current Activity Diagram
FDA
Supplier
Manufacturer
9
Desired Activity Diagram
Manufacturer
Supplier
FDA
10
Thank You!!

• Say What You Do!
• Do What You Say!

11
Standards Taxonomy

• Taxonomy according to OMB A-119
• Voluntary Consensus Standards
• More on next slide
• Non-Consensus Standards
• Company standards
• Government Unique Standards
• Guidance
• Standards Mandated by Law
• USP/NF referenced in 21 U.S.C. 351

12
Consensus Standards

• How does OMB describe a Consensus Standard
  Organization (CSO)?
• Openness
• Balance of Interest
• Due process
• Appeals process
• Consensus meaning not necessarily unanimity, but
  that each objector is advised of the disposition
  of the objection and the reason why and the body
  members can then change their votes

13
Other CSOs

• Voluntary System operates under the American
  National Standards Institute (ANSI) umbrella
• More than 600 SDOs
• Supported entirely by interested parties
• Unique in the world
• ISO, ASME, HL7, ASQ and ASTM are some of the SDOs
  relevant to pharmaceutical manufacturing

14
Organization Response

• Standards and Technology Team created within OPS
• Coordinate CDER interaction with CSO
  organizations and the USP/NF
• Advise application and DMF holders about
  implementation of PAT
• Council for Pharmaceutical Quality created a
  subgroup Standards Working Group
• Build Consensus across FDA for official positions
  on standards related issues