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Handbook of Pharmaceutical Manufacturing Formulations. Sterile Products. Edition No. 2
Informa Healthcare, September 2009, Pages: 464
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
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.
Safaraz K. Niazi Pharmaceutical Scientist Inc., Deerfield, Illinois, USA.