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GxP

All you need to know about GXP quality guidelines

GxP (Good Anything) Practice)-

GXP quality guidelines- If you are someone related with the regulated industry, then you might have very often came across the term GxP, which is the acronym for Good (Anything) Practice. This ‘anything’ can refer to either of the following descriptor- it can be manufacturing, clinical, laboratory, or clinical laboratory, signifying that these are efficaciously meeting the pre-defined guidelines and are safe to be used for the intended purpose. The guidelines are established by the U.S. Food and Drug Administration(FDA), and carry resemblance with ISO, ICH, and EU directives and principles. If your company is under the regulatory compliances, then it becomes vital for you to have in-depth understanding about these standards so as to fully comply with them and stay empowered to produce evidence in your support if ever asked for.

GMP, which is the acronym for Good Manufacturing Practice is the practice that confirms to the guidelines of FDA and other regulatory bodies which control the authorization and licensing of food, beverages, drugs and active pharmaceutical products. The practice gives the assurance about quality concerns by force of law, as it requires the manufacturers, sellers, drug packagers, processors and others to take every possible steps for ensuring that the manufactured products are altogether pure, effective and safe for consumption or use. GMP ensures that all principals and procedures are being met well and won’t pose any adverse effect on the health of consumers.

Similar to this, another international quality standard is Good Clinical Practice (GCP), which concerns with the design, conduct, performance, monitoring, inspecting, recording, analysis and reporting of clinical trials. GCP quality standard is provided by ICH; it deals with the ethical aspects that are relative with the clinical study and also assures about the protection of rights & confidentiality of clinical trial subjects. It is the GCP guidelines that state in what ways trials are required to be conducted along with outlining the responsibilities of clinical trial sponsors, clinical research investigators and clinical research associates.

Yet another compliance which you need to know about well is GLP. GLP is the abbreviation for Good Laboratory Practice- it is a FDA regulation that states the integrity of non-clinical laboratory studies and testing. The guideline assess about the safety and effectiveness of chemicals and pharmaceutical products on living beings and environment. GLP entails a set of principles that acts as the framework within which the laboratory studies are planned, performed, examined, noted, reported and archived. Other than having a prime impact over the pharmaceutical industry, agrochemicals, food additives, cosmetics, feed additives and contaminants, biocides, detergents and other also comply with this regulation to offer useful, effective and intoxicated products to their customers.

Every regulated industry, especially the pharmaceutical and life science requires to efficiently track these regulatory compliance to make sure that the products are safe and serves the intended use effectively. To stay foolproof, smart organizations are inclining to take the advantage of a next-gen ERP system, which along with aligning the business functionalities also helps in achieving the regulatory compliances without a single fail. An ERP like PROCESSMASTER helps the regulated industries to genuinely comply with GxP guidelines thereby helping organizations manage and address every standard in a timely manner.

To know more about PROCESSMASTER ERP (module-based ERP solution for process manufacturing) contact us here. You can also drop us a mail at info@processmaster.in for free demo and consultation.

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