Appropriate analytical methods are essential to the success of cleaning validation. They need to be able to adequately detect
the residues of concern. Table VI summarizes the key considerations that apply to some of the most common analytical methods
in cleaning validation. Specific analytical methods (e.g., high-performance liquid chromatography and ELISA) measure a certain
residue in the presence of expected interferences. Interferences may include degradation products and related substances,
excipients, cleaning agents, and cleaning agent byproducts. In contrast, nonspecific analytical methods (such as TOC, Bradford,
conductivity, and visual inspection) measure a general property, such as conductivity or TOC, which could result from various
analytes or sources.
Cleaning-validation protocols, like process-validation protocols, should include purpose, scope, responsibilities, applicable
products and equipment, cleaning standard operating procedures, acceptance criteria, and a requirement for a final report.
Key technical elements include residue limits, sampling procedures and analytical methods.
MASTER PLANNING FOR CLEANING VALIDATION
The master plan for cleaning validation should provide a description of responsibilities and activities for the planning and
execution of cleaning validation. It should describe the overall plan, rationale, and methodology for cleaning validation.
The plan should provide a high-level description of the cleaning-validation philosophy and strategy that will support the
validation activities performed at the site. Detailed procedures for how cleaning validation is executed should be included
in individual protocols. The plan will define the efforts required to ensure that the cleaning program complies with current
good manufacturing practices. The validation activities are documented according to the requirements of the plan to provide
sufficient scientific rationale to assess the suitability of the cleaning program to consistently clean equipment to the required