The Journal of GXP Compliance
Vol. 19, Issue 3, Oct 2015

Tim Sandle
This paper has discusses the implications of the process hold times on microbial growth during pharmaceutical manufacturing. Microbiological risk exists -- especially with biological products. If microbial contamination occurs where microorganisms enter a product in sufficient numbers and if the process hold time is long enough, the process hold...
Robert L. Creighton and Marlene Garcia Swider
FDA’s requirements regarding validation statistics are the same for US as for any other country inspected. It is our opinion that this will change as FDA advances in its relationship with other countries, understands the needs of other countries, and works toward supporting harmonization advances.
Jerry Lanese and Timothy J. Fields, editors
“GXP Talk ” provides a forum for compliance practitioners to address issues identified by the readers of the Journal of GXP Compliance. What are the Regulatory Requirement and Expectations for Process Improvements in the Pharmaceutical Industry?
Parveen Bhandola, Ph.D.
Cleaning Validation is a legally enforceable cGMP regulatory requirement per 21 CFR part 210 [1] that plays a crucial role in the overall success of quality systems in life science industry. With ever-increasing concerns about cross-contamination, most FDA inspections have recently enhanced their scrutiny of the approach that the firms take while...
The cost of new pharmaceutical products is rising annually, and consumers are rebelling against the high cost of drugs. Media report this as a way for drug company stockholders and executives to get rich at the public’s expense. And, though regulations have made generic drugs easier to market, this has not seemed to help curb the cost of...
Anne O'Meara
Anne Greene
Paige Kane
Nuala Calnan, Ph.D.
This study set out to establish the typical sources of product and process knowledge currently used to support decision-making for post-approval changes and continuous improvement strategies. It explores whether it is standard practice within industry to utilise the prior knowledge available within the CTD to support day-to-day lifecycle...
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