GXP Journal Articles
Vol. 15, Issue 4, Nov 2011

The following key points are discussed or illustrated: Statistics can contribute to real world problems and increase efficiency of data collection Nonmathematical techniques of applied statistics are illustrated Graphics contribute greatly in solving applied problems Design of experiments is important to a systematic approach.
The following key points are discussed: It is important that the results generated by a particle size analysis are thoroughly understood in the context of their appropriate application. The identification and correction of problems encountered in laser diffraction analysis are discussed. Examining the sample under a microscope is a critical...
James Kaar
,
Patrick Klemens
Art. Vice President of Quality for MedicHose, a medical component company. Art is responsible for the overall compliance of the MedicHose quality system. Roger. Director of Supplier QA. Roger is responsible for the MedicHose supplier quality process, including the approval and monitoring program. Joel. Quality Assurance Consultant with...
The following key points are discussed: Inadequate corrective action and preventive action (CAPA) is a frequent citation in US Food and Drug Administration FDA-483 observation reports and warning letters. Asking good questions is key to root cause determination and implementation of effective solutions. Good questions must be “open-ended.”...
The following key points are discussed: Knowledge of product development and technology transfer is a critical component of the CPGP Body of Knowledge. Drug development studies contribute to scientific understanding that supports the establishment of product specifications, manufacturing critical process parameters, and in-process critical...
The following important points are discussed: The contamination control plan is central to good manufacturing practice, describing the procedures and policies designed to create products under controlled conditions The contamination control plan covers all phases of a facility’s status The contamination control plan is a comprehensive...
The bacterial endotoxin test (BET) is a relatively straightforward test and has been a pharmacopeial method since 1980, when it first appeared in the United States Pharmacopeia (USP). The test, using Limulus amebocyte lysate (LAL) methodology, is described in detail in the harmonized chapters in both the European Pharmacopoeia (1) and the United...
The following key points are discussed: Proper care of experimental animals is essential for obtaining valid experimental results and minimizing the number of experiments and animals that must be employed in a study The Guide for the Care and Use of Laboratory Animals is regarded as the international standard for the care and use of laboratory...
The following key points are discussed: Cloud computing is an approach to computer services with significant potential advantages such as on-demand self-service, resource pooling, rapid elasticity, and utility billing. It is truly a paradigm shift in computer services. Cloud computing services may become available through several models such...
“GXP Talk” discusses issues identified by readers of the journal and provides current good practice to resolve those issues.
The following key points are discussed: Dirty hold is defined as the time between end of use of the equipment and the start of equipment cleaning. The condition and length of time equipment may sit idle prior to cleaning and the condition under which this storage will occur must be established and validated. Actual dirty hold times from...