Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products, 2nd Edition (Hardback) book cover

Handbook of Pharmaceutical Manufacturing Formulations

Sterile Products, 2nd Edition

By Safaraz K. Niazi

CRC Press

464 pages | 3 B/W Illus.

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Hardback: 9781420081305
pub: 2009-09-21
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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

Table of Contents


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


Sterile Products

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General