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 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 Pharmaceutical Water Systems ** Introduction: ** In the intricate world of pharmaceuticals, the quality of water used plays a crucial role in ensuring product safety and efficacy. Understanding the diverse grades of water and imp... Facility Utilities Nov 23, 2023
user Heating,Ventilation and Air-Conditioning System ** Introduction: ** In the realm of pharmaceutical and food industries, precision and quality are non-negotiable. One crucial aspect that often remains behind the scenes but plays a pivotal role in en... Facility Utilities Nov 9, 2023
user Cleanrooms in Pharmaceuticals Facilities ** Introduction: ** Cleanrooms play a pivotal role in pharmaceutical facilities, contributing to product safety, quality, and efficacy. These specialized environments are meticulously designed and mai... Cleanrooms Facility Oct 26, 2023
user Sanitization Procedures ** Introduction: ** In the world of pharmaceutical and food manufacturing, ensuring the highest level of product safety is paramount. The Good Manufacturing Practices (GMP) standards, established by t... Facility Sanitization Procedures Oct 19, 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
