The Journal of GXP Compliance
Vol. 23, Issue 2, Mar 2019

Ratul Saha
The correct identification of microorganisms is of fundamental importance to microbial taxonomist. In clinical and diagnostic microbiology accurate identification of microbes play a critical role in timely diagnosis and treatment of diseases.
Karina Lahnakoski
Many European Union (EU) countries have legalized or decriminalized the medical use of cannabis to some degree. The advent of broad acceptance of medical cannabis as public opinion shifts in the EU is driving the need for the cannabis industry to implement strict regulatory controls on the production of cannabis products.
Richard Poska
Outsourcing facilities register with FDA, are subject to FDA inspections, and must be compliant with CGMP requirements and other federal laws. This discussion addresses a recently issued revision to the FDA draft guidance describing outsourcing facility CGMP compliance and acceptable exceptions to compliance.
Tim Sandle
To partly address the shortfall of literature on particle count trending, this paper considers some different ways to assess particle data, in terms of routine assessments and where a statistical comparison of data is required.
Richard Poska
An outsourcing facility may compound non-sterile drugs, repackage drugs, prepare veterinary drugs, and other perform other functions. FDA has issued guidances on several of these activities.
Jerry Lanese
This is probably one of the most frequently asked questions that relates to the Annual Product Review that must be prepared for each drug product manufactured or marketed by a firm. When the product is entirely produced in one facility, the responsibility for preparing the Annual Product Review is clear.
Tim Sandle
A case study of how HACCP can be applied to a practical setting: the identification of environmental monitoring locations, by considering, in the HACCP lexicon, monitoring locations as ‘critical control points’.
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