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21 CFR 211.67(a) requires that any equipment, including dedicated and multipurpose equipment, is cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality,
The protocol should include a risk assessment to identify the worst-case product to clean, as well as the sample locations, sampling plan, types of testing required, acceptance criteria, and test methods you will be using. It should have a section for results, analysis, and final comments.
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into to next product has been employed for many years.
As a rough structure the validation report should contain: An executive summary listing the most prominent results of the validation. A short introduction to the speech corpus stating who produced it when and for what purpose. The results of the validation of the corpus documentation.
Process Validation Report Template Identify the impact of each equipment on the product and the corresponding risk priority. Capture photo evidence of process validation procedure. Document the details of qualification protocol such as SOPs, calibration, etc.
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This process is called validating statements. Q. Step 1: Identify the logical connector. Step 2: Choose a method to solve the statement. Step 3: Make assumptions or find the truth value of the component statements. Step 4: Deduce the truth value of the given statement.
The validation summary report should include: A description of the validation project, including the project scope. All test cases performed, including whether those test cases passed without issue. All deviations reported, including how those deviations were resolved.

cleaning validation report pdf