Healthy Skepticism Library item: 9178

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Voltz K.
Implementing standard operating procedures: prescription for a successful pharmaceutical compliance program
Clinical Research and Regulatory Affairs 1994; 11:(3-4):225-241

Abstract:

The process of developing standard operating procedures (SOPs) for the regulatory compliance program for Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), and Good Laboratory Practices (GLPs) is described. Examples of procedure manuals, documentation checklists, and regulatory checklists are presented.