Handbook of Pharmaceutical Manufacturing Formulations. Liquid Products. Edition No. 2

Informa Healthcare, September 2009, Pages: 400

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.

Highlights from Liquid Products, Volume Three include:

- practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing
- access to what an FDA auditor would be looking for during a liquid manufacturing audit
- issues that may arise during a US FDA inspection
- the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines

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. Container Closure Systems. 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. Evaluations 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: GMP Audit Template, EU Guidelines. Bioequivalence Testing Protocols. Dissolution Testing of Liquid Dosage Forms. Approved Excipients in Liquid Forms. Manufacturing Formulations.

Sarfaraz K. Niazi Pharmaceutical Scientist Inc., Deerfield, Illinois, USA.

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