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Quality By Design - A Generic Industry Perspective Edmund M. Fry Vice President of Compliance IVAX Corp. Generic Pharmaceutical Association A shared vision of quality GPhA supports the FDA CGMP initiative Generic drug manufacturing companies:

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Quality By Design - A Generic Industry Perspective

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Quality By Design - A Generic Industry Perspective

Edmund M. Fry

Vice President of Compliance

IVAX Corp.

Generic Pharmaceutical Association


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A shared vision of quality

GPhA supports the FDA CGMP initiative

  • Generic drug manufacturing companies:

    • Exist to make affordable drug therapies available to all

    • Companies, staff, volumes and revenues are smaller

  • It is completely appropriate that regulatory requirements apply to all companies small and large, as long as regulatory guidance provides flexibility in recognition of more limited resources at smaller firms


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What is Quality by Design?

“You can’t test quality into drug products” has been heard for decades – so what’s new?

  • It’s a culture - incorporates quality principles as well as strong compliance function

  • Incorporates risk assessment and management

  • Refocuses attention and resources on what’s important to the customer, i.e. the patients, health professionals, payors and distribution chain


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Quality by Design

  • Continuous improvement is a hallmark of quality by design

    • G. Taguchi on Robust Design: design changes during manufacture can result in the last product produced being different from the first product

  • In pharmaceutical manufacturing, we don’t want this – patients and physicians must count on each batch of drug working just like the batches that came before


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Quality by Design

In generic pharmaceutical manufacturing, there are additional constraints

  • Fixed bioequivalence targets

  • Regulatory requirements to duplicate formulation of innovator drug

  • Lack of access to innovator development data


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Quality by Design

Adequate resources for quality: number, qualifications, etc.

Self-assessments play key role

Continuous analysis & improvement

Change management based on good science

Focus on what’s important (risk management)

Current Regulatory Situation

Little guidance on adequate resources or qualifications

Self-assessments not trusted

Annual product reviews instead of continuous analysis

Formidable barriers to change, including intimidating enforcement emphasis

Seldom admit that anything is not important; test everything

The Changing Environment


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Suggested actions

  • Give credit for good performance

  • Continue to reduce unnecessary supplements

  • Continue to develop the Pharmaceutical Inspectorate

  • Reward process innovation

  • Eliminate unnecessary testing requirements

  • Address oversight of overseas API mfrs


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Give credit for good performance

Proven ability to operate in compliance should result in reduced regulatory burden, e.g. inspections and pre-approval review requirements

  • Factors considered by FDA in assigning inspections (D. Horowitz, Sept. 10, ’03):

    • Facility (e.g., compliance history)

    • Product being manufactured at the facility

    • Process used (e.g., process understanding)

  • Generic pharmaceutical manufacturers must be rated on the same basis as larger companies


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Continue to reduce pre-approval supplements

Examples

  • New manufacturing sites

  • Post-approval changes for sterile products


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Continue to develop the Pharmaceutical Inspectorate

FDA is doing a good job of raising technical competence of Investigators

  • System-based inspections are a meaningful approach

  • Further opportunities exist to integrate field activities with review activities; integrated uniform training; delegation of more decisions to field personnel


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Reward process innovation

  • PAT holds promise; effort actually led by FDA instead of industry

  • Similar encouragement should be provided for other advancing technologies (e.g. advanced aseptic processing)


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Eliminate unnecessary testing and other requirements

  • Prime example: sterility testing

  • Blend uniformity testing


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Address oversight of overseas API mfrs

  • Use data from pharmaceutical companies

  • Support pooling audit information


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International Initiatives

Continue to include all affected parties in policy-making initiatives

  • Due to the nature of the generic pharmaceutical industry, we may not have equivalent numbers of senior-level technical personnel who can dedicate substantial extramural time to working with ICH and other international activities

  • However, that does not mean we can’t be at the table


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Conclusion

  • Quality by Design and the FDA CGMP Initiative make excellent business and scientific sense

  • The generic pharmaceutical industry welcomes the opportunity to work with FDA


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