Introduction to GxP

GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.

1. Introduction to GxP Dr. Tim Sandle http://www.pharmamicroresources.com/

2. What is GxP ? GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The term GxP is frequently used to refer in a general way to a collection of quality guidelines. The "x" represents the applicable area e.g. “D” for “distribution”, as with GDP. In the U.S. "c" is sometimes added to the front of the initialism, indicating "current." For example, with GMP the “c” for makes it "current good manufacturing practice”.

3. What is GxP ? GxP guidelines are issued by: European Medicines Agency U.S. Food and Drug Administration World Health Organisation And other ‘ret of the world’ regulators. GxP guidelines are designed to ensure that medicinal products are safe, efficacious, and appropriately stored and distributed. Important terms are: Traceability – can the development and history of the drug product be reproduced? Accountability – to answer who was involved with the development and production of the drug product and when?

4. Good manufacturing practice (GMP) GMP applies to pharmaceuticals and medical devices. GMP is a guideline to provide provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The main purpose of GMP is to prevent harm from occurring to the end user, e.g. unexpected contamination of products, causing damage to health; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP is ensured through the effective use of a quality management system (QMS). GMP covers all aspects of production from starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are required for each process that could affect the quality of the finished product. In addition there must be documented proof that correct procedures are consistently followed at each step in the manufacturing process.

5. Good distribution practice (GDP) GDP deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user by means of various transport methods. GDP includes having tamper proof medicines and defined storage conditions e.g. temperature and humidity.

6. Good documentation practice ( GDocP ) GDocP is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. GDocP covers: Document generation Document approval Handwritten entries Electronic data management systems Copies of documents Document modifications, including audit trails Archiving and retrival

7. Good Laboratory Practice (GLP) GLP promotes the quality and validity of test data. A managerial concept covering the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Outlines the controls for research laboratories and organisations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of safety tests. Sometimes called “Good Control Lavatory Practice” ( GCLP ), e.g. as a subset of European Union Good Manufacturing Practice ( GM P).

8. Good Clinical Practice (GCP) GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Includes the documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected.

9. Good clinical laboratory practice (GCLP) GCLP is a GxP guideline for laboratory samples from clinical studies: Good clinical practice ( GCP ) does not define requirements for laboratories Good laboratory practice ( GLP ) focusses on pre-clinical analyses and not on human samples from clinical trials. GCLP : Applies the principles established under GLP for data generation used in regulatory submissions relevant to the analysis of samples from a clinical trial. Ensures that the objectives of the GCP principles are carried out. This ensures the reliability and integrity of data generated by analytical laboratories. In addition, there is Good clinical data management practice (GCDMP) GCDMP is the current industry standard for clinical data management that consists of best business practice and acceptable regulatory standards covering phases of clinical trials where clinical and laboratory information is collected.

10. Good automated manufacturing practice (GAMP) GAMP is set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. It covers: Risk-based approaches to computerized systems Calibration management Electronic Data Archiving Global Information Systems control and compliance IT infrastructure control and compliance Validation of laboratory computerized systems Validation of process control systems

11. Other uses of GxP GxPs are sometimes used to refer to: Good Storage Practices ( GSP ) Good Auditing Practices ( GAP ) Good Review Practice ( GRP ) Good engineering practice ( GEP ) Good automated laboratory practice ( GALP ) These are not commonly discussed in terms of GxP’s (they tend to be subsumed under GMP).

12. Thank you for your attention