GXP Journal Articles
Vol. 15, Issue 2, May 2011

The final step in active pharmaceutical ingredient (API) manufacture is typically a 0.2µm filtration step. This filtration step serves as a final clarification of the process pool and also as a bioburden control measure prior to the storage and further processing of drug substance (DS) to drug product (DP) (see Figure 1).
Good laboratory practices (GLPs) define the basic requirements for characterizing test and control articles used in clinical trials and studies (1). Additional information follows this regulation with regard to storage, distribution, identification, and documentation requirements. However, the focus of these regulations does not detail the most...
The following key points are discussed in this article: Criticism offered by the United States Food and Drug Administration in a FDA-issued warning letter on personnel qualifications is presented Deficiencies noted are assessed to determine whether the FDA criticism is warranted The firm’s response to the deficiencies noted is reviewed...
The following key points are discussed: Discipline to follow policies and procedures is key to GXP compliance Reminding people of GXP basics helps to create a habit of compliance GXP training should be conducted on an ongoing basis Fundamental GXP topics are suggested.
The following key points are discussed: Bulk pharmaceutical water serves either as a pharmaceutical component in product formulations or a material that decontaminates, cleans, or sanitizes product-contact equipment. Total organic carbon (TOC) and water conductivity make up the common tests prescribed by the United States Pharmacopeia (USP),...
The following key points are discussed: All workers who deal with animals need to be aware of the Animal Welfare Act regulations. The original intent of the act was to cover the handling, holding, and transportation of dogs and cats.
The following key points are discussed: Software quality is essential to every business How do we build high quality software that is acceptable to both users and regulators in challenging economic times? Differences between validation testing and quality testing are discussed Key questions are presented to facilitate the design and building...
The following key points are discussed: Coverage testing should be performed as part of equipment qualification for all process-contacting equipment utilizing spray devices for cleaning Coverage testing is used to verify that all process-contacting surfaces are wetted by cleaning liquids and to identify any potential blind spots or hard-to-...
The following key points are discussed: Test data and results generated as specified in the validation protocol are critical in the validation process because they provide the basis for the final validation report. Data recording and associated documentation for validation may not meet expected quality standards. Several actual examples...
This article is one of a continuing series in which representatives of the industry and the regulating agencies have an opportunity to express opinions on current GXP issues. Thank you for your responses to questions 40 and 41 posed in the Winter 2011 issue of the Journal of GXP Compliance. The questions are repeated below together with...