Nov 15, 2004
By:
Edward R. Arling
GMP is the acronym for Good Manufacturing Practice. The GMPs represent a set of regulations that were promulgated as a final rule by FDA in 1978 and intended to ensure the safety and efficacy of the nation's drug products. The GMPs, as we know them today, are the result of over a century of actions by industry and reactions by government and consumer groups to bring guidance and controls to the food and drug industry, resulting in a safe supply of food and medicines.
|
The Quality System Inspection Technique requires FDA investigators to follow a predetermined regimen for conducting inspections. This consistency makes it easier to assess preparedness and compliance.
Jun 1, 2004
By:
Edward R. Arling
A quality plan is a blueprint for business success and regulatory compliance.
|
|
A Fragile System in a Complex Environment
Jan 1, 2004
By:
Edward R. Arling, Ralph L. Dillon, Joseph F. Noferi
Quality assurance units are interwoven throughout the biopharmaceutical enterprise and provide support to sustain operations. Most importantly, they must have the capacity and leadership to adapt to change.
|
Nov 1, 2003
By:
Joseph F. Noferi, Esq., Daniel E. Worden, Edward R. Arling
Understanding the reach of
21 CFR Part 11 is the first step to assessing its impact. To protect your company, you need integrated quality audit solutions to evaluate the underlying validation of your electronic data.
|
|
