Quality Control of Pharmaceuticals. Compendial Standards and Specifications

      Аннотация: Quality is not an accident, it is the outcome of intelligent efforts. The quality of pharmaceutical products is essential to assure the maximum level of patient’s satisfaction. The most important criteria for the qualities of any pharmaceutical in dosage form are its safety, potency, efficacy, stability, patient acceptability and regulatory compliance. Pharmacopoeias are referred as drug standards. They provide standards, specifications and test methods that are expected to be used in the pharmaceutical industry to ensure the quality of pharmaceuticals. Furthermore, regulatory bodies are continually developing their requirements to ensure the safety, quality and efficacy for pharmaceutical development and manufacturing with respect to time. The main standard for the quality of any pharmaceutical is the intrinsic and extrinsic elements which contribute directly or indirectly to the quality parameters of pharmaceutical. Quality should be incorporated into a drug product during product and process design. The crucial objective of this book is to provide various quality control tests for pharmaceuticals, according to pharmacopoeial standards and specifications.

Ключевые слова: Pharmaceutical Sciences