ISPE Good Practice Guide
Author | : |
Publisher | : |
Total Pages | : 104 |
Release | : 2009 |
Genre | : Pharmaceutical industry |
ISBN | : 9781931879569 |
Download ISPE Good Practice Guide Book in PDF, ePub and Kindle
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Ispe Good Practice Guide PDF full book. Access full book title Ispe Good Practice Guide.
Author | : |
Publisher | : |
Total Pages | : 104 |
Release | : 2009 |
Genre | : Pharmaceutical industry |
ISBN | : 9781931879569 |
Author | : Ispe |
Publisher | : |
Total Pages | : 176 |
Release | : 2018-11-30 |
Genre | : |
ISBN | : 9781946964120 |
Author | : Ispe |
Publisher | : |
Total Pages | : 148 |
Release | : 2019-01-24 |
Genre | : |
ISBN | : 9781946964144 |
Author | : International Society of Pharmaceutical Engineers |
Publisher | : |
Total Pages | : 172 |
Release | : 2012 |
Genre | : Laboratories |
ISBN | : 9781936379422 |
Author | : Ispe |
Publisher | : |
Total Pages | : 204 |
Release | : 2019-03-25 |
Genre | : |
ISBN | : 9781946964175 |
Author | : Ispe |
Publisher | : |
Total Pages | : 80 |
Release | : 2005-09-05 |
Genre | : |
ISBN | : 9781931879361 |
Author | : |
Publisher | : Ispe Headquarters |
Total Pages | : |
Release | : 2005-01-01 |
Genre | : Technology & Engineering |
ISBN | : 9781931879392 |
Author | : |
Publisher | : Ispe Headquarters |
Total Pages | : |
Release | : 2005 |
Genre | : Technology & Engineering |
ISBN | : 9781931879422 |
Author | : International Society for Pharmaceutical Engineering |
Publisher | : |
Total Pages | : 140 |
Release | : 2012 |
Genre | : |
ISBN | : 9781936379446 |
Author | : Sam A. Hout |
Publisher | : CRC Press |
Total Pages | : 206 |
Release | : 2021-07-05 |
Genre | : Technology & Engineering |
ISBN | : 1000406091 |
This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.