Development and Validation of drug residues on equipment surfaces. Cleaning Validation

      Аннотация: The cleaning processes used in pharmaceutical operations have achieved an increasing emphasis in the past decade both by the regulatory agencies and industry itself. At this time it is generally regarded as just as critical to have effective cleaning processes as to have consistent, validated manufacturing processes. Several developments have caused this emphasis on the cleaning process. First, the new generation of products (as well as those in the current “pipeline”) tends to be more potent (e.g., many are potent in mg and sub-mg doses). Second, a series of tragic contaminations occurred over the last several years that led to serious personal injury. In addition, we know that many individuals are sensitive to various drugs and that these sensitivities, often described as allergenicities, can be very serious. The basic reason for having good, effective, consistent cleaning procedures is to prevent the contamination of products made subsequently in the same equipment. The goal is to provide pharmaceutical products of the highest quality to our patients. This is the basic regulatory requirement as well as the goal of all of those suppliers of products and services.

Ключевые слова: Analytical Method Validation, cleaning validation