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February 03, 2011
The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.
February 02, 2011
Taking care to note, file and re-check information can save one from future mishaps.
The author describes why statistical significance would impose an unreasonable burden on manufacturers.
January 27, 2011
FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.
January 20, 2011
FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.
December 02, 2010
Sometimes doing what you think is right ends up being completely and utterly wrong.
The author explains the idea of equivalence and describes how it can facilitate equipment validation.
November 30, 2010
With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.
A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.
November 02, 2010
Remaining calm, cool, and collected during mergers and inspections is a feat in itself.