ITFGIPAC TECHNICAL TEAM: SUPPLIER QUALITY CONTROL QUALIFICATION Presented by: Gordon Hansen 26 April

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ITFG/IPAC TECHNICAL TEAM SUPPLIER QUALITY
CONTROL (QUALIFICATION)Presented by Gordon
Hansen26 April 2000Rockville, MD
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SUPPLIER QUALITY CONTROL TEAM
Team membership is comprised of representatives
from 9 pharma companies and 5 key component
manufacturers.
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SUPPLIER QUALITY CONTROL TEAM
A core theme of the draft CMC guidances with
respect to component, excipient, and raw
material suppliers is summarized below Tight
standards and extensive testing by the pharma
manufacturer are required in order to assure
batch to batch quality of components and
excipients.
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TEAMS THESIS
The qualification and control of critical
components (in the areas of performance related
physical testing, extractables and leachables)
and excipients should be achieved by a
combination of appropriate scientific practices,
cGMP controls and supplier qualification systems.
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TEAMS APPROACH cGMP SURVEY

• A survey of suppliers was conducted to evaluate
  quality and compliance practices at all stages of
  component, excipient, raw materials, and active
  drug substance manufacture
• Survey requested assessment of performance
  related to 31 specific cGMP elements
• Circulated to all companies represented on Team
• Information obtained on 53 suppliers, from raw
  materials through finished component manufacture

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TEAMS APPROACH cGMP SURVEY

• Results
• Highest level of compliance is evident with
  active ingredient suppliers
• Level of cGMP awareness and compliance in the
  component and raw material supply chain is
  increasing, but needs to be improved
• Specific cGMP program elements remain to be
  generally accepted and implemented, especially
  early in supply chain

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TEAMS APPROACH cGMP SURVEY

• Results
• No generally accepted cGMP guidelines exist for
  the component supply chain
• cGMP guidelines have been drafted by IPEC
  (International Pharmaceutical Excipients Council)
  

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PROPOSALS AND COMMITMENTS

• The Team endorses the IPEC Guideline for the
  control and cGMP compliance of excipients
• The Team proposes that an industry-wide
  initiative be established to develop a cGMP
  guideline for component suppliers

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PROPOSALS AND COMMITMENTS

• The Team requests that the Agency partner with
  the pharma industry and component suppliers by
• Formally recognizing the value of a cGMP
  guideline for component suppliers by
  acknowledging in the guidance documents that if
  sufficient supplier control mechanisms are in
  place, appropriate reductions in testing will be
  considered.
• Establishing key elements and expectations for a
  cGMP guideline.
• Participation in reviewing and commenting on
  draft cGMP guidelines.