Risk Analysis Study Protocol cum Report for reducing Testing of Rinse or Swab Samples

The site is having multi-product facility; more than 315 API’s used in different formulations (Annexure I) are being manufactured here. Manufacturing area consist of 10 Granulations, 20 Compressions, 10 Coatings & 30 Packing’s respectively. As mentioned above, the areas are not dedicated. All areas in combine consist of more than 550 equipments approximately. As per the cleaning SOP, Type A cleaning of equipment shall be done after batch to batch while type B cleaning of the equipment shall be done after product to product change over. Further for cleaning verification Swab & Rinse samples are taken and tested and based on those result, line clearance is given by QA. UV Spectrophotometer is used for the verification, the rinse & swab samples are scanned at 200-380 nm for any cleaning agent residue (absorbance shall be not more than 0.059 at any wavelength). By rinse & swab analysis report it is assumed that our next upcoming product is free from any residue of cleaning agent, which is already being validated through Cleaning Validation of Cleaning Agent (SLS). While as per PIC/s guideline, no residue of cleaning shall be left after cleaning.

Till now since 2010 after cleaning validation of API &Cleaning agent, no any case of contamination related to API & Detergent had been recorded. This shows the robustness of our cleaning procedure. On the previous trend basis, Rinse & Swab sampling shall be done randomly from any area.