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Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd Edition by Sarfaraz Niazi 1420081306 9781420081305

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Handbook of Pharmaceutical Manufacturing Formulations Second Edition Volume 6 Sterile Products Sarfaraz K. Niazi Digital Instant Download

Author(s): Sarfaraz K. Niazi
ISBN(s): 9781420081305, 1420081306
Edition: 2
File Details: PDF, 4.15 MB
Year: 2009
Language: english
SKU: EB-2018842 Category: Tag:

Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd Edition by Sarfaraz Niazi – Ebook PDF Instant Download/Delivery: 1420081306, 9781420081305

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Product details:

ISBN 10: 1420081306 

ISBN 13: 9781420081305

Author: Sarfaraz K. Niazi

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:

REGULATORY AND MANUFACTURING

  1. Sterile Manufacturing Formulations Template

  2. GMP Audit Template, EU Guidelines

  3. Inspection of Sterile Product Manufacturing Facilities

  4. New Drug Application for Sterilized Products

  5. Validation of Cleaning Process

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

  7. Analysis of the Expression Construct in Cells Used for Production of rDNA-Derived Protein Products

  8. Stability Testing of Biotechnological/Biological Products

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

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

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

  12. Essential Clean-Room Design Elements

  13. Approved Excipients in Sterile Dosage Forms

MANUFACTURING FORMULATIONS
   14. Sterile Products

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Tags: Sarfaraz Niazi, Handbook, Pharmaceutical, Manufacturing