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 represents the specific descriptor. A "c" or "C" is sometimes added to the front
of the initialism. The preceding "c" stands for "current." For example, cGMP is an acronym
for "current Good Manufacturing Practices". The term GxP is frequently used 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. Consequences of GxP for information technology
A growing number of industries are becoming subject to government regulations which require
certain Best Practices to be followed. A typical example is the pharmaceutical industry :
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 by law heed various things:
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 secure username and password. 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.
Stringent record-keeping requirements and traceability: It is necessary to create and
to document 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.
Litigation and Regulation Support: Persons bringing lawsuits, and regulators, can subpoena
or otherwise demand to obtain certain information which must be available and which must have
been maintained according to law. This information must be promptly furnished to them in the
format they require. The industry must be able to satisfy such requests promptly at
any reasonable time. List of GxPs
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 Laboratory Practice, or GALP
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 Clinical Laboratory Practice, or GCLP
Good Distribution Practice, or GDP Good Documentation Practice, or GDP, or GDocP
Good Engineering Practice, or GEP Good Financial Practice, or GFP
Good Guidance Practice, or GGP 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 GMP Good Management Practice, or GMP
Good Microbiological Practice, or GMiP Good Participatory Practice, or GPP
Good Pharmacovigilance Practice, or GPvP or even GVP
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
See also Best practice
European Medicines Agency Food and Drug Administration
International Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use Japan Ministry of Health
Organisation for Economic Co-operation and Development
Validation Society of Quality Assurance The Society of
Quality Assurance is a professional group focused on GxP-regulated environments.
References ^ ISPE - GAMP® Good Practice Guide: A Risk-Based
Approach to GxP Compliant Laboratory Computerized Systems
^ United States Environmental Protection Agency. "Good Automated Laboratory Practices - Principles
and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations".
U.S. EPA, Office of Information Resources Management. Retrieved 25 February 2012.
^ K., Nitahara. "Good Automated Laboratory Practices and other standards: validation
of computer systems in the PC environment". Qual Assur 2: 96–101. PMID 8156229.
^ Food and Drug Administration. "Administrative Practices and Procedures; Good Guidance Practices".
Retrieved 10 April 2009. ^ Food and Drug Administration. "Good Guidance
Practices Database". Retrieved 10 April 2009.