What is GxP?

July 22, 2015 § Leave a comment

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Recently our team has been meetings with several pharmaceutical and medical device companies regarding IBM’s GxP Cloud offering. GxP refers to “Good Practices” in regulated industries including food, pharmaceutical, medical devices and cosmetics. In the pharmaceutical and medical device industries, these would include Good Laboratory Practice (GLP), Good Automated Manufacturing Practice (GAMP), Good Manufacturing Practice (GMP) Good Clinical Practice (GCP) and Good Clinical Data Management Practice (GCDMP). The ‘x’ is merely a placeholder.

The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. 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: this is a critical component for ensuring GxP adherence.

The pharmaceutical and medical device industries represent a tremendous (global) opportunity for the IBM GxP Cloud. In preparation for upcoming meetings, I wanted share the following details on Good Laboratory Practice (GLP), Good Automated Manufacturing Practice (GAMP), Good Manufacturing Practice (GMP) Good Clinical Practice (GCP) and Good Clinical Data Management Practice (GCDMP). I hope you find this information beneficial as you prepare to position the GxP Cloud offering with your customers.

Good laboratory practice (GLP) specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.

GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment.Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

Good Automated Manufacturing Practice (GAMP) is a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. More specifically, The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any 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.

Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, that is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines. GCP follows the International Conference on Harmonisation (ICH) of GCP guidelines. GCP enforces tight guidelines on ethical aspects of a clinical study. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. Ongoing research shows that whether conducting research involving a new drug, a behavioral intervention, or an interview or survey, GCP provides investigators and their study teams with the tools to protect human subjects and collect quality data. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors.

Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes. The U.S. Food and Drug Administration and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use have provided specific regulations and guidelines surrounding this component of the drug and device development process. The effective, efficient and regulatory-compliant management of clinical trial data is an essential component of drug and device development.

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