Open Science Journal of Pharmacy and Pharmacology 2015; 3(4): 28-32 Published online July 20, 2015 (http://www.openscienceonline.com/journal/osjpp) Cleaning Validation and Its Protocol in Pharmaceutical Industry Yasir Mehmood * Faculty of Pharmacy, University of Central Punjab, Lahore, Pakistan Email address yasirmehmoodamjad@gmail.com To cite this article Yasir Mehmood. Cleaning Validation and its protocol in Pharmaceutical Industry. Open Science Journal of Pharmacy and Pharmacology. Vol. 3, No. 4, 2015, pp. 28-32. Abstract Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. Minimizing equipment downtime has the potential to impact the efficiency and economics of pharmaceutical production. The main purpose of cleaning validation is to improve the effectiveness and consistency of cleaning in a given pharmaceutical production equipment or prevent cross contamination and adulteration of drug products with other active ingredients like unintended compounds or microbiological contamination, leads to prevent several serious problems and also useful in related studies like packaging component cleaning validation. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Active Pharmaceutical Ingredients (API) product manufacture. The benefits due to cleaning validation are compliance with federal regulations, identification and correction of potential problems, previously unsuspected which could compromise the safety and efficacy of drug products. In this article cleaning, validation and importance are discussed in brief. Keywords Validation, Regulation, API, Safety, Cleaning, Compliance 1. Introduction Cleaning validation is a documented process that proves the effectiveness and consistency in cleaning a pharmaceutical production equipment [1]. Validations of equipment cleaning procedures are mainly used in pharmaceutical industries to prevent cross contamination and adulteration of drug products hence is critically important [2]. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations [3]. The most important benefit of conducting such a validation work is the identification and correction of potential problems previously unsuspected [4], which could compromise the safety, efficacy or quality of subsequent batches of drug product produced within the equipment [5]. This paper provides a review of the current trends in cleaning validation and its related importance. 2. Procedure 2.1. Factory Premises Twice a day by using phenyl water for mopping and at the end of working day finis oil or phenyl is poured in drain holes. Insecticidal spray used when ever required. Testing Procedure: Visual examination and record should be maintained. Facility: Insectocutor and air curtain, fans, tube lights, AC plants, doors, windows, wall etc. Frequency: Cleaned on weekly basis by using duster or brush. Equipment: Possible contaminants of equipment are: Active Ingredient: The first concern in cleaning validation is the removal of residue having pharmacological actively, the absence of each is necessary.