Cleaning validation

Cleaning Validation is one of the critical elements in the prevention of cross contamination in multi-product facilities.

WHY: Cleaning validation must be done to confirm the effectiveness of any cleaning procedure in all the equipment that comes into contact with the product.

WHAT TO VALIDATE: Cleaning procedures for equipment or groups of equipment that come into contact with the product.

WHAT TO DO WHILE VALIDATING: Ensure with sufficient data that the equipment is clean for its subsequent use (Cleaning Verification).

Validation prerequisites: 

  1. Cleaning procedure
  2. Sampling Critical Points and Sampling Method and Analytical Methods
  3. Calculation of residue limits
  4. Acceptance criteria

CALCULATION OF ACCEPTANCE LIMITS OF APIs IN CLEANING VALIDATIONS

This new guideline has massive impact on the calculation of limits for cleaning validation when different medicinal products are produced in shared facilities. It also introduces the calculation of the Permitted Daily Exposure (PDE) of an active substance, described in Annex 3 of ICH Q3C (R4) Impurities and Annex 3 of VICH GL 18 and based on a structured scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data. (exists on socosur, add link)

CLEANING VALIDATION FLOW

1. Calculation of all the PDEs of all product APIs made in a manufacturing line.

2. Make a matrix of the shared products in a line.

3. Calculation of Lower Theoretical Limit and Solubility.

4. Worst Case Selection.

5. Development of the Analytical Method.

6. Validation Protocol.

7. Validation / Cleaning Lots.

8. Validation Report.

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