Sale!

Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd edition By Safaraz Niazi ISBN 9780429138867, 978-0429138867

Original price was: $70.00.Current price is: $24.99.

Instant download Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd after payment

SKU: EB_38016 Category:

Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd edition By Safaraz K. Niazi – Ebook PDF Instant Download/Delivery: 9780429138867, 978-0429138867

Full dowload Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd Edition after payment

 

Product details:

ISBN 10: 9780429138867
ISBN 13: 978-0429138867
Author: Safaraz 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
 

Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd Table of contents:

PART I 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

PART II MANUFACTURING FORMULATIONS

Sterile Products

People also search for Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd:

handbook of pharmaceutical manufacturing formulations
hand sanitizer ingredients formulation
handbook of pharmaceutical ingredients
handbook of pharmaceutical manufacturing formulations liquid products

 

Reviews

There are no reviews yet.

Be the first to review “Handbook of Pharmaceutical Manufacturing Formulations Sterile Products 2nd edition By Safaraz Niazi ISBN 9780429138867, 978-0429138867”