Good practice

Poster showing good hand-washing practice

A good practice is a procedure or set of procedures that are prescribed or accepted as being suitable or effective within a given professional or commercial setting. They are used in quality guidelines and regulations, including the pharmaceutical and food industries, for example good agricultural practice (GAP) (see more examples below).

In general, GxP is a placeholder abbreviation for the good practice within a particular field or fields, where the "x" can be substituted for the field(s) in question. GxP can also be used to refer to collections of quality guidelines.[1]

To denote the current good practice, a "c" or "C" is sometimes added to the front of the initialism (cGxP), which may hint that any good practice may be subject to future change. For example, "current good manufacturing practice" may be abbreviated "cGMP".

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 good documentation practices (GDP), which are expected to be "ALCOA":[2]

  • Attributable: Documents are attributable to an individual
  • Legible: They are readable
  • Contemporaneously recorded: Not dated in the past (backdating) or the future (forward dating), but when the documented task is completed
  • Original or a true copy: See also non-repudiation
  • Accurate: Accurately reflecting the activity documented
  • Permanent

The products that are the subject of the GxP are expected to be

  • 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.

Another version, ALCOA++[3], adds:

  • Complete: Data should not be missing
  • Consistent: Data should not deviate from a set style, for example, the abbreviation N/A should only be used for one phrase
  • Enduring: Documents should be designed to last a reasonable length of time
  • Available: Documents should be retrievable.

GxPs require that a quality system be established, implemented, documented, and maintained. As explained above, documentation is a critical tool for ensuring GxP adherence. For more information, see good manufacturing practice.

Examples of GxPs

See also

References

  1. ^ ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems
  2. ^ ALCOA to ALCOA Plus and Data integrity » Pharmaguddu
  3. ^ Follow the 10 Principles of ALCOA++
  4. ^ 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. Archived from the original on 25 August 2021. Retrieved 25 February 2012.
  5. ^ K., Nitahara (March–June 1993). "Good Automated Laboratory Practices and other standards: validation of computer systems in the PC environment". Qual Assur. 2 (1–2): 96–101. PMID 8156229.
  6. ^ Coecke S. "Guidance on Good Cell Culture Practice".
  7. ^ Food and Drug Administration (2000). "Administrative Practices and Procedures; Good Guidance Practices". Food and Drug Administration. Archived from the original on 18 January 2009. Retrieved 10 April 2009.
  8. ^ Food and Drug Administration. "Good Guidance Practices (GGP) Database". Food and Drug Administration. Archived from the original on 30 March 2009. Retrieved 10 April 2009.

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