Handbook of Pharmaceutical Manufacturing Formulations, Second Edition

Handbook of Pharmaceutical Manufacturing Formulations, Second Edition

Summary

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.

Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

• cGMP compliance
• pre-approval inspections
• stability and bioequivalence testing
• packaging commodity development
• common difficulties in formulating drugs
• changes to aNDAs

Table of Contents

Volume I:

Bioequivalence Testing Rationale and Principles.

Bioequivalence Testing Protocols-FDA-Compressed Dosage Forms.

GMP Audit Template, EU Guidelines.

Guidance on Formulating Compressed Solids.

Appendix I: Dissolution Testing Requirements of Compressed Dosage Forms.

Appendix II: Approved Excipients in Compressed Solid Dosage Forms.

Volume II:

Regulatory and Manufacturing Guidelines.

US FDA Good Manufacturing Practices.

GMP Audit Template, EU Guidelines.

Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use.

Process Validation: General Principles and Practices.

Process Validation: General Principles and Practices.

Bioequivalence Regulatory Review Process and Audit.

EU Guidelines to Good Manufacturing Practice Basic Requirements for Active Substances used as Starting Materials.

Preapproval Inspections. Formulation Factors in Uncompressed Dosage Forms.

Dissolution Testing of Uncompressed Solid Dosage Forms.

Approved Excipients in Uncompressed Solid Dosage Forms.

Uncompressed Solids Formulations.

Volume III:

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 Compliance].

GMP Audit Template, EU Guidelines.

Bioequivalence Testing Protocols.

Dissolution Testing of Liquid Dosage Forms.

Approved Excipients in Liquid Forms.

Manufacturing Formulations.

Volume IV:

Regulatory and Manufacturing Guidance.

Waiver of In Vivo Bioequivalence Study. Quality Risk Management.
Pharmaceutical Quality System.

Pharmaceutical Development.

Pharmaceutical Development in Ctd.

Scale-Up and Post-approval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment.

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

Validation of Analytical Procedures.

Good Manufacturing Requirements for Active Pharmaceutical Ingredients.

FDA Active Pharmaceutical Ingredient Manufacturing Facility Inspection.

Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.

Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products.

Impurities In New Drug Substances.

Drug Products Impurities in New Drug Substances.

Formulation Factors in Semisolid Dosage Forms.

GMP Audit Template, EU Guidelines.

Dissolution. Testing of Semisolid Dosage Forms.

Approved Excipients in Semisolid Dosage Forms.

Manufacturing Formulations.

Volume V:

Regulatory Guidance.

EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.

EDQM Certification.

GMP Audit Template, EU Guidelines.

WHO Good Manufacturing Guidelines.

Quality management in the drug industry: philosophy and essential elements.

Solid Oral Dosage Forms Validation.

Current Regulatory Status of Over-the-Counter Products.

Pharmaceutical Manufacturing Formulations.

Tablet Coating Formulations.

Volume VI:

Regulatory and Manufacturing.

Sterile Manufacturing Formulations Template.

GMP Audit Template, EU Guidelines.

Inspection of Sterile Product Manufacturing Facilities.

New Drug Application for Sterilized Products.

Validation of Cleaning Process.

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.

Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products.

Stability Testing of Biotechnological/Biological Products.

Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products.

Comparability of Biotechnological / Biological Products Subject to Changes in Their Manufacturing Process.

Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.

Essential Cleanroom Design Elements.

Approved Excipients in Sterile Dosage Forms.

Manufacturing Formulations.