Introduction - Quality assurance (QA) in the pharmaceutical industry is a critical component that ensures products are consistently produced and controlled to meet the quality standards appropriate for their…

INTRODUCTION: A crucial component of CAPA procedures in the pharmaceutical sector is root cause analysis (RCA). The goal of root cause analysis (RCA), a methodical technique used to research, is…

Introduction - An applied strategy to confirm that a procedure is appropriate to serve as a tool for quality control is called validation. Any analytical measurement's intent is to produce…

INTRODUCTION - Design Qualification includes all facets of facility and equipment design and acquisition. It is meant to have everything that could happen during the design, development, and checkout phases,…

Introduction - In any industry, quality audits are essential for guaranteeing adherence to legal standards. Comparably, quality audits are carried out in the pharmaceutical sector to ensure that the intricate…

Gummies, effervescence, soft gels, tablets, capsules, small molecules, and pills. These are known as oral solid dosage (OSD) forms, which are final drug product therapies that are swallowed, dissolved in…

The pharmaceutical sector has been subject to intense competition over the past few decades, and this pressure has not decreased. New, more effective, and scalable operational models are becoming more…

Introduction: The Annual Product Quality Review (APQR)/PQR stands as a pivotal regulatory requirement for pharmaceutical companies, mandated by the FDA and governed by cGMP guidelines. This annual review is imperative…

Introduction: Quality control and contract laboratories play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products. To uphold the highest standards, these laboratories must adhere to…

Introduction: A product can be systematically manufactured using a specific process that meets its predetermined specifications and quality attributes. This is known as validation. Established document evidence or proof offers…