Is ICH Q7 compliance required by Contract Manufacturing Organisation in Pharma? скачать в хорошем качестве

Is ICH Q7 compliance required by Contract Manufacturing Organisation in Pharma?

🎯 Welcome to Day 45 of the 90-Day Challenge of Learning with Blue Ocean Compliance! 📚 Before I share today’s learnings, I have two small requests for you 👇 1️⃣ If you know someone to whom this knowledge is valuable or can help him or her — please share this video with them. 🤝 2️⃣ Please apply the learnings on your site to experience the real transformation. 🧠💡 📺 Click the link below to subscribe to my YouTube Channel and press the 🔔 bell icon so that you never miss any of the insightful sharings I bring for you! 👉    • 5 mistakes which caused pharma companies g...   💬 Today’s Discussion: Is compliance with cGMP guidelines by Contract Manufacturing Organisations (CMOs) mandatory, or is only the Marketing Authorisation Holder (MAH) responsible for compliance? 🤔 If the CMO does not have a quality unit, is it acceptable? 🧾⚖️ If you are an API or OSD manufacturer and want to solve the challenges of compliance that may prevent you from qualifying for regulatory inspections 🏭🔍 — please do not hesitate to write to me for a solution and association. ✉️ 👩‍⚕️ Dr. Rupali Paranjape Auditor | Trainer | Mentor | Coach for Pharma Companies & Professionals 📧 Email: rupali@blueoceancompliance.in 🌐 Website: www.drrupaliparanjape.com ________________________________________ Blue Ocean of Compliance Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation ________________________________ Blue Ocean of Compliance Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation Are you struggling to solve the problems of non-compliances on your site? Even with putting your best technologies, Knowledge, and efforts do you feel clueless? If you want to protect your site from risks & huge losses due to non-compliances, If you want to know the thought process & path which would lead you to qualify a Regulatory Inspection with no-observation in a cost-effective way, Then do not miss "Blue Ocean of Compliance" #1 Best Seller book on Amazon by Dr. Rupali Paranjape. Why you must read this 👉By reading & implementing this you will be able to avoid more than 492, 483s on your site. 👉You will be able to avoid many circumstances that lead to Warning letters. 👉You will become more familiar with the enforcement actions, reasons of non-compliances & ways to overcome them in cost-effective ways. 👉You will come to know many factors which might not be discussed before to solve the non-compliance issues on the site. 👉You will know one new thought process “Blue Ocean of Compliance” 👉At the end of each Chapter Practical Assignments: Exercise is given for implementation. The beautiful part of the book is, that it is written by an experienced doer that has spent years on the shop floor in a very simple manner, in easily understandable language with examples, case studies, 492 FDA 483 observations, and many Warning Letter Case studies and much more. You may buy this book from amazon in India & globally. To book your copy click the below link; For India; Blue Ocean of Compliance https://amzn.in/9CNUVoz Out of India, you may book your copy from amazon.com. Blue Ocean of Compliance https://a.co/d/fu1fhjs _____________________________________________ #cgmp #pharmaindustry #ceos #founders #manufacturers #pharmaceuticalindustry #qualityassurance #qualitycontrol #qualityculture #quality #regulatory #manufacturing #ceomindset #ceoinsights #audits #auditor #compliancesolutions #sops #MPharm, #bpharmacy, #mpharmacy, #pharmajobs, #procedures #analytical #validation #laboratory #21cfrpart11 #dataintegrity #documentation #gdprcompliance