PDA's New Technical Report for Biotech Cleaning Validation - The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issu

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PDA's New Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.


BioPharm International
Volume 24, Issue 3, pp. 26-34

ANALYTICAL METHODS


Table 6
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

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 specifications.


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