The Journal of GXP Compliance
Vol. 24, Issue 1, Jan 2020

Natasa Vukicevic, Aneta Dimitovska, and Jelena Acevska
Pharmaceuticals are essential for human and animal health. At the same time pollution of waters and soils from pharmaceutical residues is an emerging environmental problem as well as an emerging public health concern. These are sometimes persistent and harmful for the environment. In order to protect the waters and soils in their functions as...
Alma O'Reilly and Donncadh Nagle
Change Management is one of the cornerstones of a Pharmaceutical Quality System (PQS) and is a key fundamental for maintaining its effectiveness. However, poorly planned or executed equipment changes to validated systems can pose a risk to product quality, patient safety, and business. In particular, when the change is classified as Like-for-Like...
Paul L. Pluta
Successful training of trainees is critical in the site training quality system. As with PPQ, training sessions must be well designed and conscientiously executed and must be effective. Workers use trained procedures in daily operations long after their training is completed.  Effective training should result in long-term job performance...
Tim Sandle
Although advances in imaging and automatic software can perform an objective analysis so that the variabilities with colony counting are reduced, it remains that a sizeable proportion of plate counting in microbiology laboratories is performed manually. This article offers a back to basics tutorial of colony counting.
Lorianne Richter
,
Nuala Calnan, Ph.D.
This article represents the third, in a three-part series which considers the overall effectiveness of pharmaceutical CGMP training programs. This article will focus on encompassing adult learning theory into the process of designing and delivering effective CGMP training programs and how organizations can mature beyond the training environment...
Jeanne Moldenhauer
<p>It&rsquo;s never a good idea to be a company with two warning letters in the same year. Most companies do not want even a single warning letter. It is even worse to know about the warning letters and not look at whether these same situations occur within your own facility.&nbsp;This paper describes some of the issues noted in...
Validation Master Plan Download banner