What is GxP?
GxP is the general term for the various quality systems used in the pharmaceutical and food industries. These are strict guidelines and standards that apply to and must be followed by companies in the pharmaceutical and food industries in order to guarantee the quality and safety of their products.The G stands for “Good,” the x for the various quality systems, and the P for “Practices”; thus, GxP stands for “Good x Practices.” Sometimes a lowercase “c” is added before it, resulting in cGxP. The “c” is an abbreviation for “current.” The inclusion of the lowercase “c” before “GxP” indicates that it refers to the most recent version of the relevant quality system. Even if the regulations have not yet been updated, companies are expected to operate according to the latest methods.The “x” in GxP can be replaced by the available quality systems within the pharmaceutical and food industries. Each quality system is designated by one or two letters that replace the “x.”
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A system of guidelines designed to ensure that products are consistently manufactured and inspected in accordance with quality standards.
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Is a set of guidelines followed by everyone in the industry to record raw data entries in a readable, traceable, and reproducible manner. An important concept within data integrity.
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Is a set of guidelines for the proper storage and distribution of medicines and medicine-related products for use by humans and animals.
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Is a set of guidelines for the proper conduct of laboratory work. This quality system addresses organizational processes—excluding clinical studies—for assessing the safety of chemical substances with respect to humans, animals, and the environment. GLP relates solely to how laboratory work is organized; GLP is not involved in the interpretation or scientific evaluation of the results.
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A set of guidelines that ensures the reliability of clinical trial results and the protection of patients. These regulations and rules were established by the International Conference on Harmonisation.
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Is a set of guidelines for laboratory samples from clinical trials. Compliance with these guidelines will enable clinical laboratories to ensure that data on safety and efficacy are reproducible, reliable, and verifiable, and can be easily reconstructed in a trial setting.
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Is a set of guidelines that manufacturers and other users of automation follow to maintain operational efficiency and reliability. GAMP is also a subcommittee of the International Society for Pharmaceutical Engineering (ISPE).
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A national framework of quality standards and guidelines for pharmacy practice that addresses the needs of people who use the services of (hospital) pharmacists to provide optimal, evidence-based care
Why is GxP important?
GxP was developed for industries where quality assurance is the top priority. It guarantees a certain quality standard in the industries where it is used.
Example: When people take manufactured medications, they want the product to be safe and reliable. By applying quality assurance systems (GxP), the product is manufactured to a specific quality standard, and its safety can be guaranteed.
Relationship Between Quality Systems
Each quality system has its own standards and guidelines and is used at different stages of a product’s development. GDocP is an exception and applies to all quality systems throughout the entire process from development to sale, because everything must be properly documented under every quality system. It is possible for two quality systems to apply simultaneously.
Example: GMP in conjunction with GDP. When a product is manufactured (GMP), it must also be transported (GDP) in a specific manner from location A to location B. If a product spoils at temperatures above 10°C, it must be stored, transported, and manufactured under refrigerated conditions (2–8°C).
Each quality system also has its own focus, although they may occur in a similar environment. For example, GCP, GCLP, and GLP: Good Clinical Practice (GCP) does not define requirements for laboratories, and Good Laboratory Practice (GLP) focuses on preclinical analyses rather than human samples from clinical trials. GCLP focuses on samples from clinical trials.
Normec Advipro, The Complete GxPierence!
Normec Advipro is a company specializing in various quality systems (GxP) in the pharmaceutical industry. With this expertise, we can guide pharmaceutical manufacturers from start to finish in areas such as the development, implementation, and validation of their processes. We serve both large companies and various startups and smaller firms.
Normec Advipro also operates a training center called The GxP Academy. Equipped with an operational cleanroom, it provides the ideal environment for training in the various aspects of GxP.
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