دانلود کتاب تمرین طراحی خوب برای امکانات GMP دارویی
Good Design Practices for GMP Pharmaceutical Facilities, 2ed

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Good design yields better-functioning facilities and better performance for pharmaceutical manufacturers. In particular, good design leads to shorter delivery cycles; lower costs to build and operate; better facility performance, resulting in lower costs of goods; and fewer compliance infractions. The effective application of good design practices (GDPs) offers an advantage to operators and is an essential skill for professionals. GDPs are a set of sound design approaches that offer powerful tools to help professionals develop and build facilities that efciently and safely meet the commercial and regulatory challenges of current Good Manufacturing Practices (cGMPs). The GDPs are not to be confused with cGMPs. The application of GDPs also encourages the effective accommodation of evolving technologies, which offer novel processes and the means of producing high-quality products for a global marketplace.

Contents

Chapter 1 Pharmaceutical Industry Prole
Chapter 2 Current Good Manufacturing Practices
Chapter 3 Legacy Facility Master Planning
Chapter 4 Architectural Design Issues
Chapter 5 Facility Utility Systems
Chapter 6 High-Purity Water
Chapter 7 Commissioning, Qualication, and Validation
Chapter 8 Process Engineering
Chapter 9 Oral Solid Dosage Facilities
Chapter 10 Continuous Oral Solid Dose Processing
Chapter 11 Sterile Manufacturing Facilities
Chapter 12 Biotechnology Facilities
Chapter 13 Codes and Standards
Chapter 14 Containment Technology
Chapter 15 Occupational Health and Safety
Chapter 16 Sustainability
Chapter 17 QA/QC Laboratories and Related Support Spaces
Chapter 18 Packaging and Warehousing