A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations.

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards.

The Design Analysis Handbook: A Practical Guide to Design Validation 1st Edition - This Handbook offers design engineers and managers immediately useful, meat-and-potatoes techniques for achieving design validation by analysis in an easy-to-read style

Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a large number of samples are to be analysed.

PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007

This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting.

An Overview of Validation and Basic Concepts of Process Validation: Quality Assurance View Point

An Overview of Pharmaceutical Validation and Process Controls in Drug Development.

A Guide to Best Practice - Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests.