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GxP Compliance in Pharmaceutical Industry

01/03/2011

Life Science and Healthcare Juhi Srivastava j.srivastava@tcs.com

Gxp Compliance in Pharmaceutical industry

Understanding of GxP
This refers to the "Good Practices" whose rulings are observed within the pharmaceutical industry. These are Good Laboratory Practice (GLP), Good Automated Manufacturing Practice (GAMP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). The 'x' is merely a placeholder. 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 GMP section. Consequences of GxP for information technology For a drug to be produced in a GxP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture and sale of regulated product must meet certain requirements. 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 has 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. Keeping archives: relevant audit information must be kept for a set period. In certain countries, archives must be kept for several decades. 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 has signed into the system using an electronic signature. No actions are performed by anonymous individuals.

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Gxp Compliance in Pharmaceutical industry

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 the use of digital signatures. The business case for any overhead cost of technical measures in this field is frequently justified by considering the costs associated with the potential losses associated with litigation. Investment in information technology security infrastructure and procedures are weighed against the risks and costs associated with litigation. System development in the pharmaceutical industry is associated with stringent recordkeeping requirements. Traceability is of central importance. That is, it is necessary to create a chain of decisions that lead from user needs and business goals down to the system design decisions, and the verification of proper system installation and operation. Few Example of GxPs are Good Auditing Practice, or GAP Good Agricultural Practices, or GAP Good Automated Manufacturing Practice, or GaMP Good Business Practices, or GBPs Good Clinical Data Management Practice, or GCDMP Good Clinical Practice, or GCP Good Clinical Laboratory Practice, or GCLP Good Documentation Practice, or GDP Good Engineering Practice, or GEP Good Laboratory Practice, or GLP Good Manufacturing Practice, or GMP

Good Manufactring Practice (GMP)Good manufacturing practice" or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Although there are a number of them, all guidelines follow a few basic principles. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.

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Gxp Compliance in Pharmaceutical industry

Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices) Operators are trained to carry out and document procedures. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. The distribution of the drugs minimizes any risk to their quality. A system is available for recalling any batch of drug from sale or supply. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence. GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process. Importance of GMP Compliance When you break the pharmaceutical industry down into its baser parts, it is the issue of GMP compliance which tends to have the most importance to the overall running of the industry. GMP compliance is one of the cornerstones of the pharmaceutical industry and it is imperative that manufacturers know what it means for them. GMP compliance is something that almost all manufacturers of medical devices and pharmaceutical drugs will have encountered at one point or another and, unfortunately, many will have found that they are not compliant with the most current regulations which govern the industry. Pharmaceutical consultancy firms are increasing being sought by manufacturers of all sizes to help guide them through the processes of overcoming GMP compliance hurdles. GMP Compliance - A Vital Cog in the Pharmaceutical Machine It is fair to say that the pharmaceutical industry is one of the most complex and competitive out there but it is also one of the few where the products manufactured really can be dangerous to the end user if they are not carefully manufactured. Regulatory bodies such as the FDA and MHRA are the main line of defense when it comes to protecting the public from potentially harmful products and the issue of GMP compliance will need to be taken seriously to avoid potentially very damaging scenarios such as a product recall. To make sense of the various different elements of GMP compliance, it will be worthwhile to consider the services of pharmaceutical consultancy firms who are particularly well

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Gxp Compliance in Pharmaceutical industry

versed in all aspects relating to FDA compliance. It isnt always straightforward for manufacturers to stay on top of all their compliance needs but through the use of pharmaceutical training, this whole process will become much more efficient. GMP compliance regulations are all set to become increasingly stringent and rigorous over the coming months and years and, for this reason, it makes sense to seek out a reputable pharmaceutical consulting company now who can work alongside a manufacturer on an ongoing process to make sure they keep up to speed with any change to FDA or GMP compliance guidelines.

Good Clinical Practice (GCPGood Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. In the non-clinical and research arena, the phrase good laboratory practice or GLP specifically refers to a Quality System of management controls for laboratories and research organizations to ensure the consistency and reliability and reproducibility of results. The original regulatory enforcement was first written by FDA and published in the Federal Register 43 FR 59985-60020. It was followed a few years later by EPA and as outlined in the Organisation for Economic Co-operation and Development (OECD) Principles of GLP in 1992 and has since been added to many national regulations.

Good Laboratory Practice (GLP)GLP was instituted following cases of safety and efficacy test fraud by pharmaceutical & industrial manufacturers; as a standard meant to ensure the quality, integrity, and reliability of safety data. GLP applies to nonclinical studies conducted for the assessment of the safety of chemicals to man, animals and the environment. An internationally recognized definition of GLP can be found on the website for the Medicines and Healthcare products Regulatory Agency-UK and MHRA defines GLP as: Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed,

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Gxp Compliance in Pharmaceutical industry

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. GLP can become confused with the standards of laboratory safety - wearing appropriate gloves, glasses and clothing to handle materials safely.

Conclusion
GxP (specially GMP, GCP, GLP) compliance regulations are all set to become increasingly stringent and rigorous over the coming months and years and, for this reason, it makes sense to seek out a reputable pharmaceutical consulting company or IT company who can work alongside a manufacturer or Pharma company on an ongoing process to make sure they keep up to speed with any change to FDA or GxP (specially GMP, GCP) compliance guidelines.

Reference1- http://en.wikipedia.org/wiki/GxP 2- http://en.wikipedia.org/wiki/Good_Manufacturing_Practice 3- http://en.wikipedia.org/wiki/Good_clinical_practice 4- http://en.wikipedia.org/wiki/Good_Laboratory_Practice

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