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
|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|
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
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.
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.