user Change Management * Introduction * Change is inevitable in the pharmaceutical industry, where advancements in technology, regulatory updates, and operational improvements constantly reshape the landscape. However, impl... Quality Jan 31, 2025
user Self-inspection, quality audits ** Introduction: ** What is an Audit? According to ISO 19011, an audit is a systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine ... Quality Mar 27, 2024
user Quality Management QMS ** Introduction: ** At the heart of GMP lies the commitment to ensuring that medicinal and food products meet the quality standards necessary for their intended use. As stated in GMP guidelines, Qual... Quality Mar 26, 2024
user Specifications ** Introduction: ** Adherence to Good Manufacturing Practices (GMP) is crucial to ensure the safety, efficacy, and quality of products. Specifications are critical quality standards that are proposed... Specifications Mar 14, 2024
user Calibration Management ** Introduction: ** In the highly regulated environments of pharmaceutical and food industries, precision and accuracy are paramount. Calibration management plays a pivotal role in ensuring that measu... Calibration Equipment Validation Jan 5, 2024
user Process Validation ** Introduction: ** At the heart of pharmaceutical manufacturing lies the crucial process of validation. a comprehensive journey from defining a process to ensuring it consistently produces high-quali... Validation Dec 7, 2023
user Computerised Systems ** Introduction: ** In the dynamic world of pharmaceuticals, the integration of computerized systems is not just a technological advancement; it's a critical component ensuring patient safety, product... Computerised System Validation Validation Dec 6, 2023
user Cleaning Validation ** Introduction: ** The key to pharmaceutical success lies not only in the development of groundbreaking drugs but also in the meticulous adherence to Good Manufacturing Practices (GMP). ... Equiment Cleaning Procedure Equipment Cleaning Validation Validation Nov 26, 2023
user Commissioning, Qualification, and Validation Start writing here... *Introduction* In the realm of pharmaceutical manufacturing, quality and safety are of paramount importance. Adhering to Good Manufacturing Practices (GMP) is not merely a ... Commissioning Facility Qualification Validation Oct 12, 2023
Safaa Abdel Wahab Annual Product Review in Pharma *Introduction:* In the pharmaceutical industry, adhering to Good Manufacturing Practices (GMP) regulations is paramount. These regulations necessitate the generation and analysis of a substantial volu... Annual Product Review Quality Oct 8, 2023
