Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products

ISBN-13: 9781138113794 / Angielski / Miękka / 2018 / 400 str.

Sarfaraz K. Niazi

Opis

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.

Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products presents practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing. It delineates things an FDA auditor will look for during a liquid manufacturing audit, issues that may arise during a US FDA inspection, and the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines.

　

Spis treści

REGULATORY AND MANUFACTURING GUIDANCE: Manufacturing Practice Considerations in Liquid Formulations. Oral Solutions and Suspensions. The FDA Drug Product Surveillance Program. Changes to Approved NDAs and ANDAs. Formulation Considerations of Liquid Products. Container Closure Systems. Material for Containers. Stability Testing of New Drug Substances and Products. Stability Testing: Photostability Testing of New Drug Substances and Products. Stability Testing for New Dosage Forms. Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. Evaluation of Stability Data. Stability Data Package for Registration Applications in Climatic Zones III and IV. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. EDQM Certification. Impurities: Guideline for Residual Solvents. Electronic Records and Signatures (CFR 21 Part 11 Compliance). GMP Audit Template, EU Guidelines. Bioequivalence Testing Protocols. Dissolution Testing of Liquid Dosage Forms. Approved Excipients in Liquid Forms. MANUFACTURING FORMULATIONS: Manufacturing Formulations..

O autorze

Sarfaraz K. Niazi