Vol, Edition # and Pub. Year.

H/B Vol 19/Ed 19 - 2019
H/B Vol 19/Ed 20 - 2020
H/B Vol 19/Ed 21 - 2021
H/B Vol 19/Ed 22 - 2022
H/B Vol 19/Ed 23 - 2023
H/B Vol 19/Ed 24 - 2024
H/B Vol 19/Ed 25 - 2025
H/B Vol 19/Ed 26 - 2026

New Updated Edition Annually

Handbook Generic Development
SOPs & PAI Checklists

Locum International Press.

Volume 19 - 1 - 4 (A Four Part Volume)
24 Volume Drug Development Series

Electronic Standard Operating Procedures, and a comprehensive spectrum of Validation Protocols and preapproval checklists covering development, scale-up, optimization, pivotal lots, end process validation, commercial production and process engineering.

Available on CD ROM or in print for immediate in-house use. Guidelines provided on how to convert development SOPs and PAIs into your own customised research-based-development system that meet all international regulatory guides, guidelines and regulatory requirements.

e-SOPs™ can be utilized to meet your development units own in-house needs. Designed for Generic and NDA use.
e-SOPs provide Development, Decision Trees, Formulation, Scale-up, Process Optimization & Qualification; pivotal and final large scale validation batches; analytical, cleaning and process validation; essential documentation and OGD regulatory know-how that is essential for a successful product development and a speedy FDA approval, saving queue-time and development dollars.

Essential information for Development Pharmacists, R&D Chemists, QA and Regulatory personnel. Allows management to understand the nuts and bolts on Generic ANDA and EC Development and filing in the most cost effective way.

Fully illustrated with diagrams, graphs, tables in b/w & color.

ISSN: 0793-7859

Price: Locum International Catalog



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