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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

Quality By Design - A Generic Industry Perspective

Edmund M. Fry

Vice President of Compliance

IVAX Corp.

Generic Pharmaceutical Association

a shared vision of quality
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
what is quality by design
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
quality by design
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
quality by design5
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
the changing environment
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
suggested actions
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
give credit for good performance
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
continue to reduce pre approval supplements
Continue to reduce pre-approval supplements

Examples

  • New manufacturing sites
  • Post-approval changes for sterile products
continue to develop the pharmaceutical inspectorate
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
reward process innovation
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)
eliminate unnecessary testing and other requirements
Eliminate unnecessary testing and other requirements
  • Prime example: sterility testing
  • Blend uniformity testing
address oversight of overseas api mfrs
Address oversight of overseas API mfrs
  • Use data from pharmaceutical companies
  • Support pooling audit information
international initiatives
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
conclusion
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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