Process Validation Cgmp Part 1
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Process Validation & cGMP (Part - 1)
Author: Mr. Rohit Manglik
language: en
Publisher: EduGorilla Publication
Release Date: 2024-03-24
Covers fundamentals of process validation, documentation, regulatory guidelines, and GMP principles in pharmaceutical manufacturing.
Process Validation & cGMP (Part - 2)
Author: Mr. Rohit Manglik
language: en
Publisher: EduGorilla Publication
Release Date: 2024-03-24
Advances knowledge of continuous process monitoring, quality by design, and advanced regulatory compliance in manufacturing.
TEXT BOOK OF MODERN PHARMACEUTICS
Author: Prof. (Dr.) Mukesh Chandra Sharma, Dr. Rekha Tarasingh Rajput, Dr. Prashant Singh, Ankita Malviya, Dilip Kumar Mishra
language: en
Publisher: Shashwat Publication
Release Date: 2025-03-18
Textbook of Modern Pharmaceutics is a comprehensive guide covering essential principles and advanced concepts in pharmaceutical formulation and manufacturing. It serves as an invaluable resource for students, researchers, and industry professionals in pharmaceutics. The book delves into preformulation concepts, including drug-excipient interactions, stability testing, and pharmaceutical dispersions. It provides in-depth coverage of optimization techniques, exploring statistical design, response surface methodology, and factorial designs in formulation development. The section on validation introduces pharmaceutical validation principles, calibration, regulatory guidelines, and process models, ensuring compliance with ICH and WHO standards. The book also highlights cGMP (Current Good Manufacturing Practices), focusing on building layouts, equipment maintenance, and policies crucial for maintaining product quality. Industrial management is another key aspect, discussing production organization, inventory control, sales forecasting, and cost management. A dedicated section on Total Quality Management (TQM) emphasizes the importance of quality control in pharmaceutical industries. The compression and compaction chapter explores the physics of tablet compression, consolidation, force distribution, and compaction profiles. Readers will also find detailed insights into consolidation parameters, including diffusion, dissolution, pharmacokinetics, Heckel plots, and similarity factors like f1 and f2. The statistical concepts of ANOVA, T-test, Chi-square test, and standard deviation are explained in the context of pharmaceutical research. With a blend of theoretical foundations and practical applications, the Textbook of Modern Pharmaceutics is a must-read for those aspiring to excel in the evolving world of pharmaceutics.