Designing and building a pharmaceutical facility requires the owner, engineer of record, and
constructor to be knowledgeable with regard to the industry codes and standards that apply …

Production of pharmaceuticals is one of the most highly regulated industries in the world.
Regulatory guidelines known as Good Manufacturing Practices (GMP) must be followed to …

The specification, design, qualification, and use of equipment in the various manufacturing
processes have taken on more technology-driven characteristics recently. With the advent of …

A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and
design Engineers working in the pharmaceutical and biotech industries are routinely called …

The development of standards for single-use devices in bioprocessing is critical to the
advancement of these novel devices. Over the past five years, developers, inventors, and …

In recent years, a number of graduate level programs related to pharmaceutical engineering
have been developed at the New Jersey Institute of Technology (NJIT). The reason for this is …

A regulation is a law. In the United States, all federal laws have been arranged or codified in
a manner that makes it easier to find a specific law. The Code of Federal Regulations (CFR) …

INTRODUCTION The pharmaceutical industry is a major global economic force, which
increasingly relies on the safe and efficient production of technically advanced products …

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical
device or equipment, and biotech product, this Second Edition guides readers through each …

The objective of the presentation is to discuss the Food and Drug Administration change to
the Good Manufacturing Practices (GMP) rules. The proposed changes have a direct …