As if in conformance with Darwin’s Theory of Evolution, the active pharmaceutical ingredient (API) good manufacturing practice (GMP) continues its natural process of evolution. Although Darwin’s theory was postulated for living organisms, one can relate the same theories for growth and change to the ongoing process of GMP standards development....
Systems design is the process or art of defining the architecture, components, modules, interfaces, and data for a system
System design should consider the entire system lifecycle to properly manage costs and compliance
System changes, maintenance, and future expansion or other organizational changes should be part of system design
The role of...
DownloadDraft Guidance on Good Importer Practices—The Potential Impact on Importers of FDA-Regulated Products
In January 2009, several US government agencies, including the US Food and Drug Administration, jointly published a draft guidance (1) on good importer practices (GIP).
The ADDIE model provides high-level guidance for the development and revision of programs of all sorts, including GXP training programs. The phases of the ADDIE model are analyze, design, develop, implement, and evaluate. These phases are sequential; each depends upon the successful completion of the preceding phase.
The final implementation of...
There is confusion regarding the appropriate applications of good laboratory practice (GLP) regulations and good manufacturing practice (GMP) regulations, especially with regard to when they should be applied
There may be a preference for working under GLP based on the belief that GLP regulations are less onerous and less costly than GMP
The GMP...
I have worked in companies regulated by the US Food and Drug Administration for over two decades. There is considerable satisfaction working in an industry that provides products that maintain, improve, or save lives. Healthcare companies also have the reputation for providing an excellent working environment, good career opportunities, and...
DownloadCurrent Good Tissue Practice Basics for Human Cells, Tissues, and Cellular and Tissue-Based Products
The purpose for regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps) is to prevent the introduction, transmission, and spread of communicable disease (1,2,3). HCT/Ps are regulated under 21 Code of Federal Regulations (CFR) 1271 and section 361 of the Public Health Service (PHS) Act. Some HCT/Ps are also...
Data logging is the activity of collecting information from electronic sensing instrumentation over specified time periods at predetermined intervals
Data collected may include temperature, relative humidity, chemical concentrations (i.e., % CO2), pressure, particle counters, electrical current, and many other forms of data
Applications include...
This article is one of a continuing series in which representatives of the industry and the regulatory agencies have an opportunity to express opinions on current GXP issues.
Thank you for your responses to questions 24 and 25 posed in the Winter 2009 issue of the Journal of GXP Compliance. The questions are repeated below and the responses...
The US Food and Drug Administration issued the draft guidance for industry Process Validation: General Principles and Practices, Draft Guidance in November 2008
The guidance applies to manufacturing of human and animal drug products, including biological and biotech products, active pharmaceutical ingredients (API), and the drug component of...
