Handbook of Pharmaceutical Manufacturing Formulations (2nd Ed.) Volume Three, Liquid Products
Auteur : Niazi Sarfaraz K.
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. 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..
Date de parution : 02-2018
21x28 cm
Thème de Handbook of Pharmaceutical Manufacturing Formulations :
Mots-clés :
Edetate Disodium; cGMP compliance; C05 Count; Pre-approval inspections; Drug Substances; Stability and bioequivalence testing; Container Closure System; Packaging commodity development; Magnesium Aluminum Silicate; Formulating drugs; Drug Product; Changes to aNDAs; and aBLAs; Dosage Forms; Raw Material; Proposed Retest Period; Oral Solid Dosage Forms; Parent Guideline; Retest Period; FULL DESIGN STUDIES; Intermediate Storage Condition; Shelf Life Estimation; Normal Healthy Males; Proposed Shelf Life; Solid Oral Dosage Form Products; Packaging Component; Photostability Testing; Accelerated Storage Condition; Long Term Storage Condition; Primary Degradant; Primary Packaging Components; ANDA Submission