Biological Product Inspection Issues and Regulatory Update

GMP News No. 562

GMP News
25 May 2005


Biological Product Inspection Issues and Regulatory Update

In April 2005, Jay Eltermann, CBER/FDA, gave a very comprehensive talk on recent FDA developments with regard to inspections and regulations for biologics.

His presentation provided a good insight into current inspection trends of FDA.

Part of the first section is a list of topics that regularly cause problems during reviews:

  • Validation issues
  • Insufficient information
  • Product comparability
  • Stability

In general, Jay Eltermann notices significant differences depending on the level of experience a firm has. Experienced firms frequently face problems with following existing systems and evaluating the impact of process changes on product quality. "First-timers" often have incomplete quality systems and procedures, incomplete documentation and incomplete equipment qualification and process validation.

In the second part of the presentation, you will find a considerable number of slides that give an overview of typical inspection topics concerning:

  • Facilities
  • Multi-product issues
  • Personnel
  • Process
  • Quality unit
  • Contract manufacturing

Jay Eltermann's concluding recommendations are: to keep up with the latest inspection trends and regulatory initiatives and to have meetings with FDA at critical points during the process or when major changes are anticipated.

This statement leads to the last part of the talk, which reflects on the most important regulatory initiative of FDA:

  • cGMP for the 21st Century
  • Critical path
  • Efficient risk management

The presentation ends with a table of those challenges that cause approval delays in many cases:

  • Process validation
  • Manufacturing consistency
  • Equipment and systems qualification
  • Quality oversight
  • SOPs

Jay Eltermann's presentation is of great benefit to you if you would like to get an overview of FDA's current thinking and acting concerning biologics.

You can download the slides here.

Those topics that were addressed by Jay Eltermann will be discussed in detail at ECA's European Conference "GMP-Compliance for Biopharmaceuticals", Prague, Czech Republic, 22-24 June 2005.

During an included visit of Lonza's new FDA-registered biotech production facility you will learn how current requirements are fulfilled in practice.

This outstanding event is supported by Emerging Biopharmaceutical Enterprises (EBE) – part of The European Federation of Pharmaceutical Industries and Associations (EFPIA).

Dr Ulrich Herber


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