GxP

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GxP is a general term for Good (Anything...) 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 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.[1]

Purpose[edit]

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[edit]

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[edit]

See also[edit]

References[edit]

  1. ^ ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems
  2. ^ United States Environmental Protection Agency (1995). "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. 
  3. ^ K., Nitahara (1993 Mar–Jun). "Good Automated Laboratory Practices and other standards: validation of computer systems in the PC environment". Qual Assur 2 (1–2): 96–101. PMID 8156229. 
  4. ^ Food and Drug Administration (2000). "Administrative Practices and Procedures; Good Guidance Practices". Retrieved 10 April 2009. [dead link]
  5. ^ Food and Drug Administration. "Good Guidance Practices (GGP) Database". Retrieved 10 April 2009. [dead link]