ABSTRACT
I. Objective .......................................................................................... 2 II. The Economics ................................................................................ 2
III. The Regulatory Demands with Particular Regard to Healthcare Manufacturing Regulations.................................... 4
IV. Changes in Good Manufacturing Practice.................................... 4 A. Concept of current Good Manufacturing Practice
(cGMP) ....................................................................................... 4 B. Demonstrating Change Control for GMP ............................... 5
V. Changes in Safety Practices ........................................................... 5 A. Changes in Hazard Study......................................................... 6 B. Changes in Data and Design Codes ........................................ 6 C. Changes in Hazard Analysis .................................................... 7 D. Changes in Containment Practice ............................................ 7
VI. Changes during Design.................................................................. 7 VII. Changes in Software ....................................................................... 8
VIII. National or Governmental Demands of Industry in General ........................................................................................ 8 A. Morality, Codes of Ethics, and Government Policy ............... 8 B. National Crises .......................................................................... 9 C. Public Pressure .......................................................................... 9
IX. Company Standards, Locally and Internationally ..................... 10 A. Results of Research and Development .................................. 10
X. Maintenance .................................................................................. 11 XI. Date-Related Functions ................................................................ 11
References ............................................................................................... 12
The English writer Gilbert Keith Chesterton (1874-1936) wrote in his work
Orthodoxy
, “If you leave a thing alone, you leave it to a torrent of change.” This may sound paradoxical to those newer to industry, but it is very true indeed. The objective of this chapter is to illustrate this point by giving examples of which facets and nuances of business life are prone to change and to confirm that there is little we can actually do to prevent change. We can, however, take the necessary steps to minimize negative impacts of change on our businesses, provided we can gain an understanding of the more important aspects. How change can be managed effectively and practically is covered in other chapters in this book.
