Available as a electronic
publication on CD or printed
hard copy.

Handbook Generic Development
Sterile Injections
A Two Part Development Handbook

Locum International Press.

Volume 20 (Development volume in Two Parts)
24 Volume Drug Development Series

This advanced Handbook of Pharmaceutical Generic Development (in two parts) covers the key essential aspects of the development, formulation and manufacture of sterile injections. It promotes the development and sharing of practical drug development knowledge and sterile dose technology from government agency and industry experts alike.

Covering pharmaceutical drug development by providing hands-on easy-to-understand current know-how for the sterile product development, formulation, container closure, scale-up, process optimisation and qualification, Sterile GMP, aseptic procedures, stability, pivotal and comercial validation procedures of sterile batch lots (Aqueous and lyophilized) with supporting SOPs, protocols and checklists at every development and processing stage.

Includes IQ, OQ, PQ and equipment validation and comprehensive validation checklists up to end-process validation, analytical, cleaning and process validation, critical and essential documentation peppered with extensive legal and regulatory know-how that is essential for a first time successful review for a FDA approval, saving queue-time and lost market sales.

Complete Volume ~1800 pp for Part 1 and 2 fully illustrated with diagrams, graphs, e-disks, tables in b/w & color. Available on the web and in print (soft or spiral cover) or via CD ROM.

ISSN 0793-8754 / 0793-8744

All air shipping is 100% insured for loss or replacement. Shipping rates are standard | Priority | Expedited.

Price: Locum International Catalog

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