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|Articles|March 15, 2002

BioPharm International

  • BioPharm International-03-15-2002
  • Volume 15
  • Issue 3

Specifications and Manufacturing Change Control: A Prototypic System for Electronic Document Tracking and Management

Author(s)Robert Zeid

by Robert Zeid TLI Development The corporate fantasy where everyone knows all the systems all too often collides with a nightmare reality where all the systems are known by only a few. Any specification or manufacturing change that affects various departments can quickly become a bewildering morass of proposed, actual, and implemented changes ? with few connections to actual lots and practices. Draw a line in the CMC "sand" where those changes actually began.
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Articles in this issue

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Inside Washington: Biotech Manufacturing ? Obstacle or Opportunity?

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Guest Editorial: Warning Letters ? A Symptom?

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The Importance of Freezing on Lyophilization Cycle Development

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Outsourcing Outlook: Using Earned-Value Analysis for Better Project Management

over 24 years ago

Business Benefits of Computer Systems Validation

over 24 years ago

Validation of Quantitative PCR Assays?Addressing Virus Contamination Concerns

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A System Developer's Approach to Validation

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Additional charts for the Zeid article, "Specifications and Manufacturing Change Control"

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