Scope and Approach

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A thorough validation of cleaning procedures for equipment and facilities will be conducted and accomplished based on matrices and a worst-case scenario as per this master plan.

This VMP covers the validation of cleaning procedures used at ABC Pharmaceutical Company. The scope of this plan addresses validation requirements to prove the efficacy of cleaning methods to remove residual drug products and microbial bio-burden to below predetermined limits.

CVMP will ensure that the cleaning approach of ABC Pharmaceutical Company is consistent with accepted industry practices and published health-based guidelines of the FDA and European Regulatory Agencies.

The cleaning validation approach will include, but not be limited to, the following:

• Identification of worst-case situations and development of a worst-case scenario to be used to evaluate cleaning procedures for the equipment train based on the nature of the cleaning methods used, the product and optimal equipment coverage, and the experience of the production staff responsible for day-to-day cleaning

• Utilization of a combination of visual examination, swab testing, and rinse water sampling for evaluating equipment cleanliness; development of acceptance criteria of the cleaning procedure by product/manufacturing and equipment and facilities (selected areas)

• Development of cleaning procedures that remove residual products to below levels of concern and remove the threat of product cross-contamination

• Review of existing equipment cleaning SOPs (for completeness, clarity, removing misinterpretation, and standardization)

A summary of the Cleaning Validation Matrix for all products manufactured at ABC Pharmaceutical Company's facility is presented in Matrix I. Details of the matrix as well as the equipment train in relation to bulk batch processes are presented in Matrix II.

CVMP includes the following:

• Organization of all validation activities

• Identification of the products/processes to be validated

• Specific cleaning process considerations

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• Validation approaches

• Key acceptance criteria

• Documentation requirements

• General sequencing and prioritization of validation activities

The information contained in this plan may change as its realization progresses. Besides, it shall be reviewed annually to ensure that it remains current with existing processes, equipment/facilities, and policies. All previous versions of the CVMP shall be kept on file for reference. A validation schedule shall be maintained and kept up to date to accurately reflect the current validation status.

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