locumusa.com - Ready To Go Handbook Series, complete documentation Chemistry Manufacturing and Control Dossiers containing the Active material Specifications

Ready-To-Go CMC Title 21 Series

Ready-To-Go Title 19 Handbooks

Title 21 - ' Just Production '

Title 19 - ' The Full Reference Work'

TITLE COMPARISON
Above description shows the differences between the two references series - designed for different personnel, reference
and research uses. Title 19 is designed for Drug Development to Commercial Validated Batches (from A-Z) - while Title 21 contains standard plant know-how database technology similar to a CMC technology transfer and is a more cost effective purchase. Title 21 are designed for in-house continual development and are available to IAGIM members at 2-3 products per month as the latest data becomes available to IAGIM research laboratories. All IAGIM research is solely for specific membership development use only under copyright and not for resale to non-member third parties or countries.

Ready-To-Go CMC Title 21 Series		Ready-To-Go Title 19 Handbooks
Title 21 - ' Just Production '		Title 19 - ' The Full Reference Work'
Title 21 - Ready-To-Go CMC Series Are essentially "Production Ready" complete documentation Chemistry Manufacturing and Control Dossiers containing the active material specifications, full master formulation and manufacturing process and specification up to commercial validation. (ToC) Detailed manufacturing production process, control and specification database required for large scale validated commercial processes (includes actual protocol) from 150 000 to one plus million plus dosage unit batch lots. The analytical data package with stability indicating HPLC assay and dissolution methods together with stability tabulated profile analysis are included (where not current USP methods). The product database is based on the CMC information found in a typical US ANDA file or and EU Dossier and saves many, many months of product development - eliminating costly drug development, tedious analytical development and validation, pre-formulation, formulation, ptimization, scale-up, written protocols, stability and process qualification as well as many aspects of analytical and process validation. Title 21 Handbooks are designed for development and production managers who require to expand their drug development pipeline rapidly and need to save 9-12 months in the delveopment process.		Title 19 Ready-To-Go Handbook Series. This Handbook Series (collectively known as the '120+ Series') is targeted at an advanced postgraduate R&D level and covers each and every aspect of drug development to commercial validation for the specific target title drug. These Handbooks are suitable for R&D and Generic Development units as complete authoritative reference works for the particular target drug in question (such as Tamoxifen, Famotidine or Nabumatone etc.) The Title 19 Handbooks are more significantly more detailed and complete reference works and include extensive drug development work of the specific generic product - including content uniformity qualification and/or hardness range and dissolution profiles for tablets as appropriate. The text includes detailed drug development procedures and a FDA-level Development Report not found in the Title 21 Series. Title 19 Handbooks are updated annually in March and September The Reference work contains additional up-to-date commercial production CMC databases, stability and comparative dissolution profiles and CDP graphs against the innovator that is imminently suitable for immediate manufacturing qualification, as found in the adjacent Title 21 Ready-To-Go CMC Series.
TITLE 21 - CMC		TITLE 19 - HANDBOOKS
TITLE COMPARISON Above description shows the differences between the two references series - designed for different personnel, reference and research uses. Title 19 is designed for Drug Development to Commercial Validated Batches (from A-Z) - while Title 21 contains standard plant know-how database technology similar to a CMC technology transfer and is a more cost effective purchase. Title 21 are designed for in-house continual development and are available to IAGIM members at 2-3 products per month as the latest data becomes available to IAGIM research laboratories. All IAGIM research is solely for specific membership development use only under copyright and not for resale to non-member third parties or countries.