GxP is an acronym that refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications. The overall intent of GxP requirements is to ensure that food and medical products are safe for consumers and to ensure the integrity of data used to make product-related safety decisions.
The term GxP encompasses a broad range of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and others, each of which has product-specific requirements that life sciences organizations must implement based on the 1) type of products they make and 2) country in which their products are sold. When life sciences organizations use computerized systems to perform certain GxP activities, they must ensure that the computerized GxP system is developed, validated, and operated appropriately for the intended use of the system.
GxP was established by the Food and Drug Administration (FDA) and encompasses different standards recognized as:
G – stands for “Good”
P – stands for “Practice”
x – variable depending on the application. It can be M for “Manufacturing”, C for “Clinical”, L for “Laboratory”, S for “Storage”,
D for “Distribution”, R for “Review”, etc.
What is GxP?
GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet
their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.
GxP ensures that regulated organizations comply with specific and secure manufacturing and storage processes and procedures
which determine effective research standards for non-clinical laboratory trials and safe human-subject clinical trials. GxP’s
guidelines focus on :
• 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.
• Data Integrity (DI): the reliability of data generated by the system. DI could be determined by the following activities:
» Identifying the data generated by the system during critical processes (data flow diagram)
» Defining the DI requirements (e.g. ALCOA data attributes) during the lifecycle of data
» Identifying the risks and mitigation strategies (e.g. technical or procedural controls) to avoid DI breaches.
Who is impacted by GxP?
Regulated industries including food, pharma, medical devices, and cosmetics are impacted by GxP. GxP guidelines and
regulations are global; some of the popular regulators include FDA in the US, TGA in Australia, and HS-SC in Canada. GxP
includes varied regulation sets, but the most common are GCP, GLP, and GMP:
GCP (Good Clinical Practice)
GCP is an international quality standard that is provided
by the International Conference on Harmonisation
(ICH), an international body that defines standards
which governments can transpose into regulations
for clinical trials involving human subjects. It controls
experimentation on humans done for the sake of
advancement in medical sciences and serves as a quality
benchmark as well as a moderator that keeps such
experimentation in check.
• GLP (Good Laboratory Practice)
GLP is the non-clinical counterpart for GCP. These
guidelines apply to non-clinical studies conducted for
the assessment of the safety or efficacy of chemicals
(including pharmaceuticals) to humans, animals, and the
environment.
GMP (Good Manufacturing Practice)
GMP consolidates the practices required to conform to
the guidelines recommended by agencies that control
authorization and licensing for the manufacture and
sale of food, drug, and active pharmaceutical products.
These guidelines provide minimum requirements that
a pharmaceutical or a food product manufacturer must
meet to ensure that the products are of high quality and
do not pose a risk to the consumer or public.
Good manufacturing practices, along with good laboratory
practices and good clinical practices are overseen by
regulatory agencies in the United States, Canada, Europe,
China, and other countries. The most common GMP guidance
documents are:
• EU Good Manufacturing Practice (GMP) Guidelines,
Volume 4
• US FDA current Good Manufacturing Practice (cGMP)
guidelines: 21 CFR Part 11, 210, 211, and 820
• WHO Good Manufacturing Practices for pharmaceutical
products, Annex 4 to WHO Technical Report Series, No.
908, 2003
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.
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 practice". 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.
Examples of GxPs[edit]
- Good agricultural and collection practices, or GACP(s)
- Good agricultural practice, or GAP
- Good auditing practice, or GAP
- Good automated laboratory practice, or GALP[2][3]
- Good automated manufacturing practice, or GAMP
- Good business practice, or GBP
- Good cell culture practice, or GCCP[4]
- Good clinical data management practice, or GCDMP
- Good clinical laboratory practice, or GCLP
- Good clinical practice, or GCP
- Good documentation practice, or GDP, or GDocP (to distinguish from "good distribution practice")
- Good distribution practice, or GDP
- Good engineering practice, or GEP
- Good financial practice, or GFP
- Good guidance practice, or GGP[5][6]
- Good horticultural practice, or GHP
- Good hygiene practice, or GHP
- Good laboratory practice, or GLP
- Good management practice, or GMP
- Good manufacturing 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 practice, or GPP
- Good recruitment practice, or GRP
- Good research practice, or GRP
- Good safety practice, or GSP
- Good storage practice, or GSP
- Good tissue practice, or GTP