IQOQ

HVAC

Water Systems

Computers

Cleaning

Analytical

FP Process

Written Protocols

Reporting Results

Statistical Analysis

Sigma Six Rules

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Volume and Year
Vol. 14 - 2014
Vol 15 - 2015
Vol 16 - 2016
Vol 17 - 2017
Vol 18 - 2018
Vol 19 - 2019
Vol 20 - 202

Int. Journal of Process Validation
Covering Solid, Semisolid & Liquid Dosage Forms

Locum International Press.
Each volume contains eight issues per year.

The International Journal of Process Validation
A specialist pharmaceutical journal covering aspects on pharmaceutical process validation, protocols and interpretation of validation test results. Designed for pharmaceutical validation units in the NDA/ANDA CMC (chemistry manufacture control) and drug development sectors including detailed aspects of NDA/ANDA (bio/pivotal) and commercial validation batch manufacture.
Reviews key IQOQ, HVAC, Water, Analytical, Cleaning and Process Validation and drug product specifications and range limits, through standardized optimization and qualifications studies.

A forward looking peer reviewed journal that is relevant from the bench to the boardroom. Addresses the most up-to-date developments in CMC technology.

An essential first read for drug development chemists and scientists working in CMC arena of NDAs and ANDAs. An excellent source of know-how information on the nuts-and-bolts of today's drug development pipeline.

Regulatory know-how
Key know-how on CDER and OGDs expectations of the bio/pivotal batch manufacture highlighting side-by-side batch comparisons between bio/pivotal regulatory batch lots and commercial validation batches.

Full coverage
A comprehensive new forum filled with essential process validation data associated with CMC and Generic Drug Development, manufacture, analytical and cleaning procedures.

Each issue targets a specific dosage form detailing developmental and scale-up topics. Each Journal issue contains material dedicated to the review of a specific dosage form and specific development and scale-up topics.

This Journal features process validation articles, written technical protocols and Validation Checklists, SOPs and Side-by-Side specification comparisons of all major dosage form parameters ranging from A (Analytical) to V (FP Validation).

A primary source journal to fill the ever changing information gap for CMC and Generic Drug Validation. The Journal highlights a multidisciplinary approach between all key development, engineering and production departments.

Subscription Option Availability Print

$1499.00 - Print Edition (single-user airmail print edition worldwide)
$1699.00 - Corporate single license single pharma campus - (Print)
$1999.00 - Corporate multiple-user license - (print + CD edition maximizes distribution and readership for multiple pharma campus).


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