GxP - Citizendia

This is about the pharmaceutical term. For other uses see GXP

The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry. This is about standards for quality assurance For other uses see GXP GxP is a general term for Good Practice Quality guidelines In the vernacular quality can mean a high degree of excellence (“a quality product” a degree of excellence or the lack of it (“work of average quality” or a property of Pharmacology (from Greek grc φάρμακον pharmakon, "drug" and grc -λογία -logia) is the study of how Drugs Its abbreviation comes from a guideline beginning with "Good" and ending in "Practice" with the specific practice descriptor in between.

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 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 Feng Shui Practice, or GFSP
Good Guidance Practice
Good Hygiene Practices, or GHPs
Good Horticultural Practices, or GHP
- Good Viticultural Practices, or GVP
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 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 Tissue Practice or GTP (21CFR1271 US requirements for tissue transplantation)
Good Tourism & Hospitality Practices, or GTHP

GMP is the most commonly known instance of GxP. The term Good Agricultural Practices (GAP can refer to any collection of specific methods which when applied to Agriculture, produce results that are in harmony with the values Good Automated Manufacturing Practice ( GAMP) is a technical sub-committee known as a COP (Community Of Practice of the International Society for Pharmaceutical Engineering Good Clinical Data Management Practice ( GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation (ICH an international body that defines standards Good Distribution Practice or GDP deals with the guidelines for the proper distribution of medicinal products for human use Good Engineering Practice or GEP is applied to engineering and technical activities to ensure that a company manufactures products of the required quality as expected by the Good Laboratory Practice generally refers to a system of management controls for laboratories and research organisations to ensure the consistency and reliability Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice' is a term that is recognized worldwide for the control and management Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice' is a term that is recognized worldwide for the control and management Good safety practice ( GSP) are those Protocols dealing with Safety. The term GxP is only used in a casual manner, to abstract from the actual set 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. Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice' is a term that is recognized worldwide for the control and management

Consequences of GxP in IT

For the drug to be produced in a GxP compliant manner, these practices must be applied to any computer systems involved in the development, manufacture and sale of regulated product. Information technology ( IT) as defined by the Information Technology Association of America (ITAA is "the study design development implementation support

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 is 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. In law a lawsuit is a civil action brought before a Court in which the party commencing the action the Plaintiff, seeks a legal or equitable remedy
Keeping archives: relevant audit information must be kept for a set period, several decades in certain countries. A decade is a period of 10 Years (since 1594 a factor of 10 difference between two numbers, or sometimes a set or a group of ten (since 1451 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 signs into the system using electronic signatures. 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 by means of digitally signing activities. A digital signature or digital signature scheme is a type of asymmetric cryptography used to simulate the security properties of a handwritten Signature

The business case for any overhead in technical measures in this field is easily made, if one considers the importance of winning some of the most spectacular litigation cases that are attributed to the pharmaceutical industry. In law a lawsuit is a civil action brought before a Court in which the party commencing the action the Plaintiff, seeks a legal or equitable remedy This is also the perspective that you should use to understand the sense and nonsense of high investments in your IT security concept (IT infrastructure, standard operating procedures for system administration).

At the same time, system development in the pharmaceutical industry needs more attention than usual on its record-keeping. Traceability is of central importance, creating a chain of decisions that lead from user needs and business goals down to the design decisions of the system, and the qualification of its installation and operation.

Purpose

Consequences of GxP in IT

See also