Validation of Pharmaceutical Processes Third Edition

Introduction; Support and utility systems; Sterilization, sanitization, and sterility assurance; Sterile product manufacturing; Secondary manufaturing; Primary manufacturing; Manufacturing related activities; Computerized systems; Laboratory methods and qualily assurance; General topics

Validation of Pharmaceutical Processes Third Edition

James Agalloco, Frederick J. Carleton

New York, NY

2007

Abstract

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.
Presenting theoretical knowledge and applied practical considerations, this title

· provides an in-depth discussion of recent advances in sterilization
· identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions

· explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results

· blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions.

Citation

James Agalloco, Frederick J. Carleton. Validation of Pharmaceutical Processes Third Edition, New York, NY, 2007.

Collection

Hóa học

Related document

Validation of Pharmaceutical Processes Third EditionBakery Products Science and TechnologyFood analysis

Validation of Pharmaceutical Processes Third Edition

Bakery Products Science and Technology

Food analysis

QR code

Validation of Pharmaceutical Processes Third Edition

Content

  • Thứ Ba, 10:34 08/06/2021

Tin tiêu điểm

PGS.TS Nguyễn Thị Hồng Nga, Giám đốc - Trung tâm Đào tạo Sau đại học trao tặng 02 đầu sách ngoại văn cho Trung tâm Thông tin - Thư viện

Thứ Sáu, 07:37 24/05/2024
Hướng dẫn khai thác Bộ sưu tập tài nguyên giáo dục mở (OER)

Hướng dẫn khai thác Bộ sưu tập tài nguyên giáo dục mở (OER)

Thứ Bảy, 15:58 04/05/2024

Truy cập hàng triệu sách điện tử miễn phí với The Online Books Page

Thứ Hai, 08:38 22/01/2024
5 khóa học miễn phí về thiết kế đồ họa

5 khóa học miễn phí về thiết kế đồ họa

Thứ Tư, 09:33 13/12/2023

7 khóa học “Kỹ thuật cơ khí” sinh viên ngành Cơ khí cần biết

Thứ Sáu, 13:57 08/12/2023

Các bài đã đăng

Internet of Things (IoT) for Automated and Smart Applications

Thứ Ba, 14:22 17/09/2024

Cách học tiếng Anh thần kỳ mở ra cánh cửa tương lai tươi sáng cho cuộc đời bạn

Thứ Ba, 10:21 10/09/2024

小説 ミラーさんII -みんなの日本語初級シリーズ = Tiểu thuyết Mirror-san II - Minna no Nihongo Sơ cấp

Thứ Ba, 10:11 10/09/2024

Reflect 5: Reading & Writing (Student's Book)

Thứ Ba, 10:02 10/09/2024

Analytics in Finance and Risk Management

Thứ Ba, 09:52 10/09/2024

Work on your Vocabulary – Elementary A1

Thứ Ba, 10:29 08/06/2021

Chemical Reactor Design, Optimization, and Scaleup Second Edition

Thứ Ba, 10:02 08/06/2021

Environmental Chemistry: Microscale Laboratory Experiments

Thứ Ba, 09:53 08/06/2021

Thuật thuận tâm lý

Thứ Hai, 15:40 07/06/2021

Engineering fundamentals: an introduction to engineering

Thứ Hai, 15:10 07/06/2021