Safaraz K. Niazi

Handbook of Pharmaceutical Manufacturing Formulations

Sterile Products

• Broschiertes Buch

Produktbeschreibung

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products. With the increasing number of potent products joining the long list of proven sterile products, the technology of manufacturing these products has evolved into a very sophisticated industry. Highlights of

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Produktdetails

• Verlag: Taylor & Francis Ltd
• Seitenzahl: 458
• Erscheinungstermin: 14. Oktober 2024
• Englisch
• Abmessung: 280mm x 210mm
• Gewicht: 850g
• ISBN-13: 9781032931302
• ISBN-10: 1032931302
• Artikelnr.: 71548787

Inhaltsangabe

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.