Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for their intended use. In order to be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance. Recent EU and FDA reports demonstrate that qualification, validation and electronic records are priority […]
Quality Risk Management (QRM) principles require the systematic evaluationof risk, patient safety and product quality based on scientific knowledge, dataand experience.Regulatory bodies expect QRM to be seamlessly integrated into the QualityManagement System (QMS) framework by using the life cycle approach. Thisintegration involves the implementation of both formal and informal riskassessment tools that support the elements defined in ICH Q9 for […]
This 3 day course will cover important pharmaceutical utility systems that areimportant for proper functionality of the manufacturing plant, such as:Water (Potable Water, Purified Water and Water for InjectionSteam (Plant, Industrial)Pure Steam/Clean SteamSystem and Process Gases (Compressed air, Nitrogen). References: ISPE Baseline Guide – Water and steam systemsApproaches to commissioning and qualifications of pharmaceutical waterand steam systems.Sampling for pharmaceutical water, […]