Enhance Annual Product Review Process at Pharmaceutical Company in Puerto Rico

Abstract

Annual Product Review (APR) is a requirement from Good Manufacturing Practices (cGMP) under the FDA (Food and Drug Administration) and European Medicine Agency (EMEA). The EMEA refers to Annual Product Quality Review (APQR). The APR function is to assess the need for re-validation, and continue suitability and reproducibility of the manufacturing and control processes. The main objective of the study was to identify opportunities to reduce time to prepare the APR Analytical Section. The project methodology applied was DMAIC improvement strategy coming from Lean Six Sigma principles. After the analysis of the data collected, the opportunities identified could reduce the analytical section completion time by 43%. In addition, recommendations that will eliminate waste and standardize activities for QA (Quality Assurance) and QC (Quality Control) will eliminate another 36%. The proposed recommendations comply with procedures and corporate guidelines maintaining Company compliance, therefore project objective was successfully achieved. Key Terms - Annual Product Review, Annual Product Quality Review, Code of Federal Regulations (CFR), Good Manufacturing Practice; DMAIC.