The Journal of GXP Compliance
Vol. 23, Issue 4, Jul 2019

Ivan Soto
Inspection readiness for validation is an area that is often overlooked and not well managed in industry. Most companies typically put more focus on inspection readiness for manufacturing, quality management systems, and quality control. Inspection readiness for validation tends to be inadequately structured.
Tim Sandle
Monitoring the effectiveness of the laboratory quality management systems is essential in maintaining proper function and required compliance. Both external and internal audits can produce valuable information, while identifying problems in the laboratory allowing for improvements leading to updated processes and procedures. This article...
Milenko Pavičić
Thierry Wagner
Many factors impact the integrity of cleanroom garment systems, necessitating the completion of cleanroom garment validation. This article reviews current and emerging regulations and standards, while proposing a risk- and science-based quality-by-design approach for the development, implementation and validation of sterile cleanroom garment...
Paul L. Pluta
This is part 3 in a multipart series of discussions in which common concepts utilized in manufacturing and validation. Here the author discusses the proper development of training content and the successful trainer delivery. Discussions include personal background and experience; training content technical expertise; and human factors and...
Alex Debreceni
Consideration must be made when mapping warehouse space for storage of pharmaceuticals or other heat/cold sensitive substances to avoid impact to the product. This article discusses items such as geographic location, thermal conduction in walls, ventilation systems and placement, etc.
Paul L. Pluta
This article discusses accepted technical writing principles and applies them to writing for compliance. High level objectives for compliance documents, including suggestions for a structured approach to document preparation are included, as well as detailed recommendations such as sentence length and paragraph length and procedures for document...
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