The Journal of GXP Compliance
Vol. 18, Issue 2, May 2014

At IVT's 15th Annual Computer and Software Validation Conference, Joseph Zec and Lana Tong discussed the source of much of the discord between the quality assurance (QA) group and the information technology (IT) group. As they discuss in this presentation, much of the hostility between the two groups comes from different mindsets and perceived mutually exclusive goals. However, as Zec and Tong explained, there are some...
Orlando Lopez
The safety of a computer system is reflected by the confidentiality, integrity, and availability of the system. The integrity of the systems includes the integrity of the electronic records (erecs). Records provide evidence of various actions taken to demonstrate compliance with instructions (e.g., activities, events, investigations, and, in the...
David Markovitz
In our good manufacturing practice (GMP) workshops, we always state that working in one of the FDA-regulated industries is a privilege. Certainly it's a privilege to work in an industry with an honorable goal of improving the quality of life. However, along with that privilege comes an awesome responsibility, the responsibility to do the...
Jeanne Moldenhauer
Since the very first rapid microbiology method was introduced, pharmaceutical companies have been concerned with the potential regulatory approval of these methods and the regulatory issues associated with the methods. For many companies, this has been a major barrier to implementation of these methods. Today, within pharmaceutical and...
Jeanne Moldenhauer
Gressett, et al. of Alcon Laboratories was the first rapid sterility test method approved by the Center for New Drugs (CDER) of the US Food and Drug Administration (1). This test method utilized the ScanRDI technology. This method was attractive for drug testing since the sterility test could be completed in approximately four to six hours,...
Keith Bader
Lora Cameron-Landis
John Hyde
Derek Kichula
Process design, the first stage in the US Food and Drug Administration lifecycle approach to process validation, lays the foundation for process understanding and control. The work of Stage 1 enables subsequent Stage 2 and 3 to be successful. Process design involves planning and forethought, often by utilizing risk analysis and design-of-...
Jane Weitzel
At IVT’s Lab Compliance Week conference, held in Philadelphia from December 3–5, 2013, a session was held to discuss the USP stimuli article Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. The following questions and comments were collected and...
Scott Sutton, Ph.D.
The past two years has seen dramatic change in the regulation of compounding pharmacies. As a result of demonstrated quality issues with medicines related to the growth of compounding pharmacies into national outsourcing suppliers, the Food, Drug and Cosmetic Act (FD&C Act) has been amended to separate these entities from the traditional...
David W. Vincent
The Asian pharmaceutical manufacturing industry is becoming more complex, with some Asian countries moving more aggressively than others to supply their to regulated markets such as the US and Europe. Emerging markets, poised to account for about 45% of the world’s gross domestic profit by 2018, are projected to represent the majority of growth in...
Jerry Lanese
Timothy J. Fields
This column is one of a continuing series in which representatives of the industry and regulatory agencies have an opportunity to express opinions on current GXP issues. Thank you for your responses to the questions posed in the last issue of the Journal of GXP Compliance. They follow.
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