Cleaning Validation: Complete guide for health-based approach in chemical cross contamination risk assessment.

1. Abstract: Cross contamination is a major concern in pharmaceutical industry, especially with long term dosing and accumulative possible effects. The risk is dependent on many factors that can be divided into three main groups: - 1.1. Individual related - starting from the genomic makeup, age, gender, environment, even their diet and psychological state, which in return, alters the individual response to contamination and to any pharmaceutical API. 1.2. Formulation related: - like it`s clean-ability, solubility of the API, batch size, maximum daily dose or inactive materials and most importantly the PDE (permitted daily exposure) of the API/s, which covers the toxicological profile of this API, including its genotoxic, reproductive toxicity, sensitizing potential or any adverse effects that would result from long or short term cross contamination. 1.3. Facility related - As the machine SSA (Shared Surface area between product (A) as the contaminant and Product (B) as the contaminated). The following approach is based upon EMA recommendations on health based exposure limits. It aims to address all the three groups mentioned above to give a scientific rational, on how to evaluate the cleaning process efficiency. Keywords: - Cleaning validation; Cross contamination risk assessment; health-based exposure limits; Chemical swab limits; Chemical contamination. Abbreviations:- PDE( Permitted daily exposure), MACO( Maximum allowed carryover), SAL( Surface area limit), SSA(Shared surface area, ICH( International committee of harmonization), API( Active pharmaceutical ingredient).