Publication
Article
BioPharm International
BioPharm International-03-15-2002Volume15 Issue 3
Specifications and Manufacturing Change Control: A Prototypic System for Electronic Document Tracking and Management
Author(s):
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.
Articles in this issue
Inside Washington: Biotech Manufacturing ? Obstacle or Opportunity?
Guest Editorial: Warning Letters ? A Symptom?
The Importance of Freezing on Lyophilization Cycle Development
Outsourcing Outlook: Using Earned-Value Analysis for Better Project Management
Business Benefits of Computer Systems Validation
Validation of Quantitative PCR Assays?Addressing Virus Contamination Concerns
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
Related Videos
Related Content
