Structured Approach for Compliance Determination of FDA Regulated Tablet Compression Process

Abstract

Tablets are the most popular unit dosage form used by the Pharmaceutical Industry to provide health treatment to patients in the United States. It is important to control process critical parameters (variables) such as weight, thickness and hardness of the unit dosage form to provide the patient with the same drug levels obtained during clinical studies. There are also quality attributes that are inherent to product quality such as shape, color, texture, and general appearance. Without robust in-process controls, it is very likely to have undesired effects such as manufacturing yield issues, rework or re-processing, customer complaints, and possible observations from regulatory agencies that may affect not only economically but also the company quality reputation. For this reason it was developed a comprehensive method, structured to help as a guideline to understand the current level of compliance for pharmaceutical tablet compression facilities regulated by the FDA. Key Terms - cGMP, process controls, recall, tablet compression.