Guideline for CAPA (Corrective and Preventive Action) handling procedure PURPOSE To define the procedure for handling of Corrective and Preventive Action. SCOPE This guideline is applicable for all Corrective and Preventive Action that are recommended if any, but not limited to the following documents: Incident / Deviation – Investigation Change control Laboratory deviations … Read more
Smoke Study in Clean Rooms of Pharmaceuticals Clean rooms play a pivotal role in the pharmaceutical industry, providing controlled environments where critical processes are conducted to ensure product quality, safety, and efficacy. A smoke study is a fundamental test performed in clean rooms to evaluate the effectiveness of airflow patterns, ventilation, and containment systems. The … Read more
Pharma CAPA Pharma CAPA – Corrective and Preventive Actions (CAPA) are fundamental to the pharmaceutical industry’s commitment to ensuring product quality, safety, and compliance with regulatory requirements. CAPA is a systematic approach used to identify, investigate, and resolve deviations, non-conformities, and potential issues that may arise during the manufacturing or distribution of pharmaceutical products. The … Read more
Medicine and Drug Manufacturing in Pharmaceuticals: Ensuring Quality, Safety, and Accessibility The pharmaceutical industry plays a critical role in global healthcare by manufacturing medicines and drugs that improve and save countless lives. Medicine and drug manufacturing in pharmaceuticals is a complex and highly regulated process that involves research, development, production, and quality control. The quality, … Read more
HPLC Method Validation: Ensuring Reliable and Accurate Pharmaceutical Analysis High-Performance Liquid Chromatography (HPLC) is a powerful analytical technique widely used in the pharmaceutical industry for drug analysis, quality control, and research purposes. The reliability and accuracy of HPLC results are crucial to ensuring the safety and efficacy of pharmaceutical products. Method validation is an essential … Read more
Unraveling the Power of Corrective and Preventive Actions (CAPA): Enhancing Quality and Driving Continuous Improvement Corrective and Preventive Actions (CAPA) is a fundamental component of a robust Quality Management System (QMS). CAPA processes enable organizations to identify, investigate, and resolve quality issues, as well as implement preventive measures to prevent their recurrence. In this comprehensive … Read more
Unveiling the Essence of Quality Management Systems: A Comprehensive Guide to Ensuring Excellence and Customer Satisfaction Quality is a paramount factor in the success of any organization, regardless of its industry or sector. To consistently deliver products and services that meet or exceed customer expectations, organizations rely on robust Quality Management Systems (QMS). These systems … Read more
Unlocking the Science of Bioequivalence Studies: Unveiling the Key to Generic Medications Bioequivalence studies play a pivotal role in the pharmaceutical industry by ensuring the safety and effectiveness of generic medications. These studies are designed to demonstrate that a generic drug product is pharmaceutically equivalent and bioequivalent to its reference-listed drug (RLD). In this comprehensive … Read more
Achieving Excellence with Six Sigma: Driving Process Improvement and Quality Assurance In today’s competitive business landscape, organizations strive for excellence in terms of process efficiency, quality assurance, and customer satisfaction. Six Sigma is a data-driven methodology that empowers organizations to identify and eliminate process defects, reduce variability, and drive continuous improvement. By implementing Six Sigma … Read more
HPLC System Software Validation: Ensuring Accuracy and Reliability High-Performance Liquid Chromatography (HPLC System) is a widely used analytical technique in various industries, including pharmaceuticals, biotechnology, environmental analysis, and food and beverage. It allows for the separation, identification, and quantification of chemical components in complex mixtures. While the hardware components of an HPLC system play a … Read more