Risk Assessment of QMS Not Effective, an effective Quality Management System (QMS) forms the foundation of consistent product quality, regulatory compliance, and patient safety in pharmaceutical manufacturing and other regulated industries. The QMS integrates policies, procedures, processes, resources, and responsibilities…
In pharmaceutical manufacturing, the calculation of Active Pharmaceutical Ingredient (API) quantities plays a critical role in ensuring that each batch meets the intended strength, purity, and quality attributes. Failure to verify API calculations can lead to a range of serious…
1️⃣ Hazard Description Visual inspection is a critical step for detecting: Failure to perform visual inspection can result in defective or non-compliant products reaching patients. 2️⃣ Potential Causes 3️⃣ Potential Consequences 4️⃣ Risk Evaluation Matrix Aspect Assessment Severity High (potential…
Technology transfer is the formal process by which product and process knowledge developed during research and development is transferred to commercial manufacturing. It encompasses the transfer of manufacturing processes, analytical testing methods, in-process controls, cleaning procedures, and all relevant documentation…
In pharmaceutical tablet manufacturing, tablet coating is a critical process that enhances product stability, controls drug release, masks unpleasant taste, and improves appearance. One of the most essential tools in this process is the spray gun, which atomizes and applies…
1. Identify the Critical Quality Attributes First, you must define what characteristics are critical for the product. Examples: 2. Stability Studies Shelf life is primarily determined by Stability Studies, which include: a) Real-Time Stability Testing b) Accelerated Stability Testing c)…
Enterprise Resource Planning (ERP) is an integrated software solution that enables organizations to manage and automate core business processes within a unified system. ERP systems consolidate data and workflows across functional areas such as finance, supply chain, manufacturing, procurement, human…
1. What is Media Fill? Media fill (Process Simulation): Regulatory Expectation: Frequency: 2. Hazard Identification Hazard: Failure to perform or complete required media fill studies. Potential Causes: 3. Potential Impacts / Consequences Impact Area Description Product Quality Undetected contamination risk—no…
Risk Assessment for Flow Property of Granules in Pharmaceutical Manufacturing Introduction In solid oral dosage form manufacturing, particularly in tablet and capsule production, the flow properties of granules are a critical quality attribute. Granules must possess adequate and consistent flowability…
Risk Assessment for Culture Issues in the Pharmaceutical Industry Introduction In the pharmaceutical industry, organizational culture is a critical factor influencing GMP compliance, data integrity, product quality, and ultimately, patient safety. Culture encompasses the values, behaviors, attitudes, and decision-making patterns…
Analytical Method Validation (AMV) is a critical process in the pharmaceutical industry, ensuring that analytical methods used for testing drug substances and drug products are suitable for their intended purpose. The reliability, accuracy, and consistency of analytical data are essential…
Introduction In pharmaceutical manufacturing, excipients play a crucial role in ensuring the quality, stability, and performance of drug products. While they are considered “inactive” ingredients, their impact on the safety, efficacy, and manufacturability of formulations is significant. Regulatory authorities require…