Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products / Edition 2

by Safaraz K. Niazi

Overview

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.

Highlights from Sterile Products, Volume Six include:

• formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications
• specifications of a manufacturing facility to manufacture compliant sterile products
• NDA or aNDA filing requirements of sterile products
• an alphabetical presentation of formulations of pharmaceutical products based on their generic names

Product Details

ISBN-13:	9781420081305
Publisher:	Taylor & Francis
Publication date:	09/21/2009
Edition description:	2nd ed.
Pages:	464
Product dimensions:	8.70(w) x 11.20(h) x 1.50(d)

Table of Contents

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 rDNA-Derived Protein Products
Stability Testing of Biotechnological/Biological Products
Derivation and Characterization 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 Clean-Room Design Elements
Approved Excipients in Sterile Dosage Forms

MANUFACTURING FORMULATIONS
Sterile Products