Your Guide to Achieving GMP Excellence
Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to the quality of pharmaceutical products. QRM is an integral part of the Pharmaceutical Quality System (PQS) and is essential for ensuring the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. This article provides a detailed…
The Pharmaceutical Quality System (PQS) is a comprehensive framework that ensures the consistent production and control of pharmaceutical products in accordance with quality standards. The PQS integrates Good Manufacturing Practices (GMP) and Quality Risk Management (QRM) principles to safeguard the quality, safety, and efficacy of pharmaceutical products. This article provides a detailed explanation of the…
Product Quality Review Reports are comprehensive evaluations of pharmaceutical products conducted periodically to ensure consistency, compliance, and continuous improvement. These reports assess the quality of products, processes, and systems to identify trends, highlight areas for improvement, and maintain product quality standards. Key Components of Product Quality Review Reports: Review Scope: Overview of the products and…
Self-inspection reports are documents that detail the findings and outcomes of internal evaluations conducted by organizations to assess their compliance with regulations, quality standards, and best practices. These reports help identify areas for improvement, ensure adherence to guidelines, and maintain high standards of quality and safety. Key Components of Self-Inspection Reports: Scope of Inspection: Description…
Training Records Training records are documents that track the training activities of employees within an organization. These records capture details of training programs attended, skills acquired, and certifications obtained by employees. Training records are essential for ensuring compliance, assessing competency, and promoting professional development. Key Components of Training Records: Employee Information: Details of the employee…
Distribution Records Distribution records are documents that track the movement of products from the manufacturer to the end user or consumer. These records are essential for ensuring the proper handling, storage, and delivery of goods to maintain their quality and integrity throughout the distribution process. Key Components of Distribution Records: Product Details: Information about the…
Recall Records Recall records are documents that capture information related to the recall of products from the market due to safety concerns, quality issues, or regulatory non-compliance. These records document the entire recall process, including initiation, communication, retrieval, and resolution of recalled products. Key Components of Recall Records: Reason for Recall: Explanation of the reason…