Text Book of Modern Pharmaceutics  (English, Paperback, Dr Sanghadeep Sukhadeo Gajbhiye)

The preformation concepts in pharmaceutical sciences involve understanding drug-excipient interactions, stability kinetics, and stability testing methods. These interactions play a critical role in drug formulation, where techniques like emulsions, suspensions, and SMEDDS (Self-Micro Emulsifying Drug Delivery Systems) are employed. Optimization techniques in pharmaceutical formulation focus on identifying the most efficient parameters to enhance drug processing and product quality. Various statistical methods such as Response Surface Methodology (RSM), factorial designs, and contour designs are applied to improve formulation development. Pharmaceutical validation is a key aspect of ensuring product quality and safety. This involves following ICH and WHO guidelines for equipment calibration, process validation, and the validation of specific dosage forms. Types of validation, including design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), are essential for maintaining compliance with regulatory standards and ensuring that the manufacturing process consistently produces products meeting predetermined specifications.Current Good Manufacturing Practices (cGMP) govern the policies and objectives that ensure pharmaceutical products are produced with high standards of safety and quality. These practices cover the layout of facilities, equipment maintenance, and overall operational efficiency.