In the wake of the continue shortage of hand sanitizers to prevent the spread of COVID-19 pandemic, I am presenting the product bundle “Hand Sanitizer for Compounders”. This product includes 51 files that will guarantee a 100% control of the bulk manufacturing of 2 hand sanitizer’s formulas, one with active ingredient Alcohol 80% and the other with Isopropyl Alcohol 75%, developed by the World Health Organization (WHO) and approved by the US Food and Drug Administration (FDA) to be manufactured on GMP operating facilities, even if they do not hold a permit for the manufacturing of OTC drug products, as all hand sanitizers are currently classified.
Work your way up with a robust Quality System built around this manufacturing process where you not only will have guaranteed the issuance of any size batch manufacturing record in less than 5 minutes, but also will count with the strong support of over 100 Quality Control points incorporated into the manufacturing process; the use of the dynamic workbook MasterSAR will help you guarantee that you are delivering the best Hand Sanitizer to the consumer.
Other regulatory requirements covered in this product bundle are procedures (SOP) for the completion of Master and Batch Manufacturing Records, specifications for all raw materials, labels, and finished products, working instructions, flow charts, and more. As part of the acceptance criteria to release the finished hand sanitizer to the public, I have included the testing of 2 toxic contaminants that have been responsible for hundreds of recent recalls by the FDA.
This product bundle is a practical approach that embraces the concept of Quality-by-Design and covers every belt color on the Six Sigma philosophies and principles.
