The Journal of GXP Compliance
Vol. 19, Issue 4, Nov 2015

Tim Sandle
This paper presents an overview of the validation of microbiological methods, considering some of the limitations and outlining the key criteria that may be applicable for assessment. Such a review is additionally useful given the revision process in relation to the United States and European Pharmacopeia in relation to alternative methods, and...
Michael H. Anisfeld
In the US, training shall be by a “qualified individual”–what makes a “qualified individual?” Is this a training professional (perhaps an ex-teacher) who knows the theory and practice of teaching (perhaps only to grade school children, which is very different from teaching adults), but who does not know anything of the technology being discussed?...
Orlando Lopez
Centered on the electronic records integrity, the Medicines and Healthcare Products Regulatory Agency (MHRA, United Kingdom (UK) medicines and medical devices regulatory agency) is one of the first regulatory agencies to publish a broad data integrity guideline document .
The lifeblood of any quality system, or any constituent within a quality system, is documentation. The pharmaceutical industry is inundated with documentation in many forms. From policies and procedures, to data collection forms and logbooks, the integrity, perhaps even the foundation of our industry, relies heavily on the recording of vital...
Parveen Bhandola, Ph.D.
This discussion addresses the application of the lifecycle approach to cleaning validation. It is intended to help in the development of compliant, effective, and efficient cleaning validation processes and programs following a structured lifecycle approach. Several case studies are also presented.
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