With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.14. Quality. Systems. and. Risk. Management. Approaches. Joseph D. Nally and Laura L. Nally Nallianco LLC, New Vernon ... Final Guidance and Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Programanbsp;...
|Title||:||Good Manufacturing Practices for Pharmaceuticals, Sixth Edition|
|Author||:||Joseph D. Nally|
|Publisher||:||CRC Press - 2006-12-26|