This is about standards for quality assurance. For other uses see GXP (disambiguation)

GxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical

Pharmacology

Pharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...

 and food industries.

The titles of these good practice guidelines usually begin with "Good" and end in "Practice", with the specific practice descriptor in between.
GxP represents the abbreviations of these titles, where x (a common symbol for a variable) represents the specific descriptor.

A "c" or "C" is sometimes added to the front of the acroynm. The preceding "c" stands for "current." For example, cGMP is an acronym for "current Good Manufacturing Practices." cGMP is the most well known example of a GxP. The term GxP is only used in a casual manner, to refer in a general way to a collection of quality guidelines.

Purpose

The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics.

The most central aspects of GxP are:

• Traceability: the ability to reconstruct the development history of a drug or medical device.
• Accountability: the ability to resolve who has contributed what to the development and when.

Documentation is a critical tool for ensuring GxP adherence. For more information, see Good Manufacturing Practice

Good Manufacturing Practice

"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...

.

Consequences of GxP for information technology

For a drug to be produced in a GxP compliant manner, some specific information technology

Information technology

Information technology is the acquisition, processing, storage and dissemination of vocal, pictorial, textual and numerical information by a microelectronics-based combination of computing and telecommunications...

 practices must be followed. Computer systems involved in the development, manufacture and sale of regulated product must meet certain requirements.

The pharmaceutical industry therefore must heed various things that are somewhat neglected in other industries.

• Secure logging: each system activity must be registered, in particular what users of the system do, that relate to research, development and manufacturing. The logged information has to be secured appropriately so that it cannot be changed once logged, not even by an administrative user of the system.
• Auditing: an IT system must be able to provide conclusive evidence in litigation cases, to reconstruct the decisions and potential mistakes that were made in developing or manufacturing a medical device, drug or other regulated product.
• Keeping archives: relevant audit information must be kept for a set period. In certain countries, archives must be kept for several decade
  Decade
  A decade is a period of 10 years. The word is derived from the Ancient Greek dekas which means ten. This etymology is sometime confused with the Latin decas and dies , which is not correct....
  
  s. Archived information is still subject to the same requirements, but its only purpose is to provided trusted evidence in litigation cases.
• Accountability: Every piece of audited information must have a known author who has signed into the system using an electronic signature. No actions are performed by anonymous individuals.
• Non-repudiation: audit information must be logged in a way that no user could say that the information is invalid, e.g. saying that someone could have tampered with the information. One way of assuring this is the use of digital signature
  Digital signature
  A digital signature or digital signature scheme is a mathematical scheme for demonstrating the authenticity of a digital message or document. A valid digital signature gives a recipient reason to believe that the message was created by a known sender, and that it was not altered in transit...
  
  s.

The business case for any overhead cost of technical measures in this field is frequently justified by considering the costs associated with the potential losses associated with litigation. Investment in information technology security infrastructure and procedures are weighed against the risks and costs associated with litigation.

System development in the pharmaceutical industry is associated with stringent record-keeping requirements. Traceability is of central importance. That is, it is necessary to create a chain of decisions that lead from user needs and business goals down to the system design decisions, and the verification of proper system installation and operation.

List of GxPs

• Good Auditing Practice, or GAP
• Good Agricultural Practices
  Good Agricultural Practices
  The term Good Agricultural Practices can refer to any collection of specific methods, which when applied to agriculture, produces results that are in harmony with the values of the proponents of those practices...
  
  , or GAP
• Good Agriculture and Collection Practice, or GACP
• Good Aquaculture & Fishery Practices, or GAFP
• Good Automated Manufacturing Practice
  Good Automated Manufacturing Practice
  Good Automated Manufacturing Practice is a trademark of the International Society for Pharmaceutical Engineering . The ISPE's guide The Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that...
  
  , or GaMP
• Good Business Practices, or GBPs
• Good Civil Engineering Practice
• Good Clinical Data Management Practice
  Good Clinical Data Management Practice
  Good Clinical Data Management Practice is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form...
  
  , or GCDMP
• Good Clinical Practice
  Good clinical practice
  Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
  
  , or GCP
• Good Clinical Laboratory Practice
  Good Clinical Laboratory Practice
  Good Clinical Laboratory Practice is a GxP Guideline for laboratory samples from clinical studies.GCP does not define requirements for laboratories and GLP focusses on pre-clinical analyses and not on human samples from clinical trials. Therefore the British Association of Research Quality...
  
  , or GCLP
• Good Distribution Practice
  Good distribution practice
  Good Distribution Practice deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.GDP regulates the division and...
  
  , or GDP
• Good Documentation Practice
  Good Documentation Practice
  Good Documentation Practice is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. While some GDP standards are codified by various competent authorities, others are not but are considered cGMP...
  
  , or GDP
• Good Engineering Practice
  Good Engineering Practice
  "Good engineering practice" or "GEP" is a term applied to engineering and technical activities to ensure that a company manufactures products of the required quality as expected by the relevant regulatory authorities...
  
  , or GEP
• Good Financial Practice, or GFP
• Good Guidance Practice, or GGP
• Good hospital practice
• Good Hygiene Practices, or GHPs
• Good Horticultural Practices, or GHP
• Good Viticultural Practices, or GVP
• Good Information Systems Practice, or GISP
• Good Information Technology Practice, or GITP
• Good Laboratory Practice
  Good Laboratory Practice
  In the experimental research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical ...
  
  , or GLP
• Good Logo Practice, or GLgP
• Good Manufacturing Practice
  Good Manufacturing Practice
  "Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
  
  , or GMP
• Good Management Practice, or GMP
• Good Microbiological Practice, or GMiP
• Good Pharmacovigilance Practice, or GPvP
• Good Pharmacy Practice, or GPP
• Good Policing Practices, or GPPs
• Good Road Traffic Engineering Practice
• Good Road Transportation Practice
• Good Research Practice, or GRP
• Good Recruitment Practice or GRP
• Good Safety Practice
  Good safety practice
  Good safety practice are those protocols dealing with safety. The term is often used in connection with occupational safety and health and may vary between industries or sectors.-See also:*Best practice*Consumer protection...
  
  , or GSP
• Good Storage Practice, or GSP
• Good Service Practice, or GSP
• Good Tissue Practices or cGTP
• Good Tourism & Hospitality Practices, or GTHP
• Good Wellbeing Practice, or GWP

See also

• Best practice
  Best practice
  A best practice is a method or technique that has consistently shown results superior to those achieved with other means, and that is used as a benchmark...
  
  
• European Medicines Agency
  European Medicines Agency
  The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
  
   (EMEA)
• Food and Drug Administration
  Food and Drug Administration
  The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
  
   (FDA)
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• Japan Ministry of Health
• Organisation for Economic Co-operation and Development
  Organisation for Economic Co-operation and Development
  The Organisation for Economic Co-operation and Development is an international economic organisation of 34 countries founded in 1961 to stimulate economic progress and world trade...
  
   (OECD)
• Validation (drug manufacture)
  Validation (drug manufacture)
  Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...