{"product_id":"how-to-validate-a-pharmaceutical-process-paperback-9780128041482","title":"How to Validate a Pharmaceutical Process (Paperback) 9780128041482","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eHow to Validate a Pharmaceutical Process\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cp\u003eThis essential research companion for practitioners engaged in pharmaceutical process validation features a how-to approach to develop and implement a sustainable pharmaceutical process validation program\u003c\/p\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eSteven Ostrove (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780128041482, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePaperback, published 17 June 2016\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e218 pages\u003cbr\u003e22.9 x 15.1 x 1.5 cm, 0.36 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003ci\u003e \u003c\/i\u003e\u003cp\u003eHow to Validate a Pharmaceutical Process provides a “how to? approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the \u003ci\u003eExpertise in Pharmaceutical Process Technology\u003c\/i\u003e \u003ci\u003eSeries, \u003c\/i\u003ethis book\u003ci\u003e \u003c\/i\u003eillustrates the methods and reasoning behind processes and protocols.  It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why? is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e1. Introduction\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection I What is Process Validation and Why do Process Validation?\u003c\/b\u003e2. Defining Process Validation3. Brief Review of the Regulations and Guidelines4. The Role of Change Control\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection II Stage I – Process Development\u003c\/b\u003e5. Starting the Process Validation Program6. Equipment and Utility Qualification7. Dealing with Computers and Automation Validation8. Process Development\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection II Process Qualification \u003c\/b\u003e9. The Process Validation Protocol 10. Dealing with Deviations\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection III Continued Process Verification \u003c\/b\u003e11. Collecting and Evaluating Production12. Use of Statistical Process Control – pPk, Pk, cPk, cP\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection IV Other Related Activities\u003c\/b\u003e13. Cleaning- Verification to Validation14. Facility Qualification\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Probability \u0026amp; statistics [\u003ca title=\"See our other books on Probability \u0026amp; statistics\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Probability%20\u0026amp;%20statistics%20%5BPBT%5D%22\"\u003ePBT\u003c\/a\u003e], Pharmacology [\u003ca title=\"See our other books on Pharmacology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmacology%20%5BMMG%5D%22\"\u003eMMG\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Academic Press","offers":[{"title":"Default Title","offer_id":46648362893592,"sku":"9780128041482","price":28.49,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9780128041482.jpg?v=1694090846","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/how-to-validate-a-pharmaceutical-process-paperback-9780128041482","provider":"Freshly Printed Books","version":"1.0","type":"link"}