GxP
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- This is about standards for quality assurance. For other uses see GXP
GxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical 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."
- Good Auditing Practice, or GAP
- Good Agricultural Practices, or GAP
- Good Agriculture and Collection Practice, or GACP
- Good Aquaculture & Fishery Practices, or GAFP
- Good Automated Manufacturing Practice, or GaMP
- Good Business Practices, or GBPs
- Good Civil Engineering Practice
- Good Clinical Data Management Practice, or GCDMP
- Good Clinical Practice, or GCP
- Good Distribution Practice, or GDP
- Good Documentation Practice, or GDP
- Good Engineering Practice, or GEP
- Good Financial Practice, or GFP
- Good Guidance Practice, or GGP [1], [2]
- 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, or GLP
- Good Logo Practice, or GLgP
- Good Manufacturing Practice, or cGMP
- Good Management Practice, or GMP
- Good Microbiological Practice, or GMiP
- 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, 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
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.
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[edit] 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.
[edit] Consequences of GxP for information technology
For a drug to be produced in a GxP compliant manner, some specific information technology 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 decades. 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 signatures.
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.
[edit] Notes
- ^ Food and Drug Administration (2000). "Administrative Practices and Procedures; Good Guidance Practices". http://www.fda.gov/cder/audiences/iact/GGP.htm. Retrieved on 10 April 2009.
- ^ Food and Drug Administration. "Good Guidance Practices (GGP) Database". http://www.fda.gov/cdrh/ggpmain.html. Retrieved on 10 April 2009.
[edit] See also
- Best practice
- European Medicines Agency (EMEA)
- Food and Drug Administration (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 (OECD)
- Validation (drug manufacture)
