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

H/B Vol 17/Ed 14 - 2014
H/B Vol 17/Ed 15 - 2015
H/B Vol 17/Ed 16 - 2016
H/B Vol 17/Ed 17 - 2017
H/B Vol 17/Ed 18 - 2018
H/B Vol 17/Ed 19 - 2019
H/B Vol 17/Ed 20 - 2020

New Edition Annually





Handbook Generic Development
Master Formula & Processes

Locum International Press.

Volume 17 - A window to your drug development pipeline
24 Volume Drug Development Series

A Glimpse into the Future
This unique 10 part Series in the Handbook of Pharmaceutical Generic Development provides in each of the series ten CDs consisting of ten individual state-of-the-art real life commercial Master Formulations together with the full manufacturing process.

Title 17 Series opens a window into the associations research and development product pipeline. Title 17 allows generic drug researchers to view ten individual key formulae and process data and then select the desired pipeline products and upgrade to the full database of the Title 21 CMC Ready-To-Go Production Dossiers.

All processing and control details present. Authoritatively written in a practical hands-on manner by pharma industry experts to the level of both FDA and MCA/EU commercially approved manufacturing processes, highlighting the wide variety of technical documentation and product development expertise.

The general Table of Contents for each commercial generic drug is shown below and acts as a technology window into the 120+ Ready-To-Go Series.

Special Features in TOC

1. Master Formula per dosage unit (mg / tab) per strength
2. Master Formula per dosage unit (% / tab) per strength
3. Production Master Formula per 100 000 + units per strength
4. Production Master Formula per commercial batch
5. Master manufacturing instructions 100000 - 500 000 + units
6. Master manufacturing instructions per validation batch
7. Processing or other IPQC / QA data (varies)
8. Master packaging instructions

All processing and in-process control details are highlighted. Procedures are authoritatively written in a practical hands-on manner by industry experts to the level of both FDA and MCA commercially approved manufacturing processes. Title 17 data is evaluate formula, process and manufacturing equipment in order to upgrade and purchase individual products under Title 21 CMC Ready-To-Go Series. The System is not designed as a production CMC dossier as is Title 21 Ready-To-Go Series and should not be used as such. Title 17 is a window into the 120+ Ready-To-Go Series

Formula and processes in the series are currently in production in the US or EU or both. Product and process specifications and quantities are the exact commercial quantities and amounts.

Membership Qualification

Title 17 Series - Eligibility of drug development know-how technology limited to present and past association members of three of more years continuous membership. New IAGIM members are welcome to join for a three year period in order to qualify, subject to Association Rules and Copyright conditions. IAGIM members holding joint positions in both industry and academia or dual industry positions need to obtain a multiple-user license to cover all parties and development projects or knowhow technology obtained via IAGIM association.

Title 17 Series is written in a tabulated and summarized modular design form as a standardization drug development platform.
Some restrictions apply - All rights reserved
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