On Cleaning Validation

Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particle, dust, lubricants, raw materials, intermediates. Mainly cleaning is performed to remove product and non-product contaminating material. Ineffective cleaning can lead to adulterated product, which may be from previous product batches, cleaning agent or other extraneous material introduced into generated by the process. In many cases, the same equipment may be used for processing different products. To avoid contamination source or facility configuration there is a need to ensure that cleaning procedure must strictly follow carefully established and validated method of execution. INTRODUCTION: Validation is documented evidence which provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes 1 . Cleaning validation is documented evidence with high degree of assurance that one can consistently clean a system or piece of equipment to predetermined and acceptable limits. Cleaning validation is primarily applicable to the cleaning of process manufacturing equipment in pharmaceutical industry. It is necessary to have effective cleaning programs in place because of regulatory requirements. However more fundamental reason is that to produce products that are as pure and free from contamination to extent that is possible and feasible 2 . QUICK RESPONSE CODE DOI: 10.13040/IJPSR.0975-8232.4(9).3317-27 Article can be accessed online on: www.ijpsr.com DOI link: http://dx.doi.org/10.13040/IJPSR.0975-8232.4(9).3317-27 Why Cleaning Validation: To verify the effectiveness of cleaning procedures and to ensure no risks are associated with cross contamination of active ingredient or detergents/sanitizer. When Cleaning Validation: 1. Initial qualification of process/ equipment. 2. Critical change in a cleaning procedure. 3. Critical change in formulation. 4. Significant change in formulation. 5. Change in a cleaning process. 6. Change in a cleaning agent . Advantages of Cleaning Validation: 1. Safety: Validation can also result in increased operator safety. Properly calibrated, validated instruments and gauge used to reduce accident and results in safety. 2. Better Customer quality: Through proper validation, market recall is avoided which results in better customer care and quality of the product 4 .