Cognidox Business Development Specialist l eQMS for medical device & pharma l Prices starting from £500 per month l ISO 13485, GxP, GAMP, FDA compliant eQMS l Helping QA consultants build a recurring revenue model
Hi Network, We focus a lot on the benefits of a QMS in the medical device industry, but what about #pharma? Perhaps one of the most prevalent topics is the #ICHQ10 Pharmaceutical Quality System guidelines. The ICH Q10 guidelines are a recommended model for building a Quality Management System for the pharma industry. Based on the #ISO9001 quality standard, they were designed to be used with regional #GMP requirements. Below are four essential pillars of the pharmaceutical quality system (PQS) as specified in the guidelines: 1️⃣ Process Performance & Product Quality Monitoring Ensures precision through data analysis and statistical methods to enhance product quality and process efficiency. 2️⃣ CAPA System This is a critical component: a CAPA system Identifies root causes and implements corrective and preventive actions to maintain quality standards. 3️⃣ Change Management Ensures controlled and managed changes in a systematic way, e.g. changes to process, equipment, and material changes. This helps maintain quality and uphold product integrity through its lifecycle. 4️⃣ Management Review Regular assessments of process performance and product quality are essential to drive continuous improvement and informed decision-making. You will find the full blog about ICH Q10 Pharmaceutical Quality System Guidelines by this link https://lnkd.in/e5Tg6TfS. If you’re in the pharmaceutical industry, what does your current QMS look like? #Pharma #QMS #PQS #eQMS #CAPA #ISO9001 #GMP #ProductLifeCycle #ProductQuality