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Promotes the development and sharing of practical drug development knowledge and sterile technology by agency and industry experts alike.

The world's most definitive & authoritative current generic drug development series available anywhere.

 

LOCUM INT. PRESS
Vol, Edition # and Pub. Year.

H/B Vol 20/Ed 16 - 2016
H/B Vol 20/Ed 17 - 2017
H/B Vol 20/Ed 18 - 2018
H/B Vol 20/Ed 19 - 2019
H/B Vol 20/Ed 20 - 2020
H/B Vol 20/Ed 21 - 2021
H/B Vol 20/Ed 22 - 2022
H/B Vol 20/Ed 23 - 2023
H/B Vol 20/Ed 24 - 2024

New Edition Annually

Locum Publishers Clients
(Handbooks and Journals)

Handbook Generic Development
Sterile Injections

A Two Part Development To Final Production Handbook

Locum International Press.

Volume 20 - (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series


This advanced drug development Handbook of Pharmaceutical Generic Development 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.

SEAMLESS INTEGRATION
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC and Regulatory personnel. Each and every document, protocol and procedure in Part I + II is expertly referenced to the appropriate module number in the CTD / e-CTD system thus providing a fully seamless and effortless integration into either US, EU and Asian application files and dossier. All IAGIM technology is purposely and uniquely dove-tailed in regulatory drug product applications -worldwide applications made simple and precise.

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 in two parts 1890-2000 pp. Part 1 and 2 fully illustrated and annotated with diagrams, flow charts, formula, graphs, spectra, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover opens flat)

ISSN 0793-8754 / 0793-8744


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