. July 22, 2019. By TheraEditor. 0 CommentsGood Manufacturing Practice (GMP) is asystem to ensure products are consistently produced and controlled according toquality standards.The “c” in cGMP stands for currentwhich indicates that the most recent standards, technology, and methods arebeing applied to operations.The terms are largely interchangeable, with one major difference. The use of the term cGMP implies a commitment to the highest available standards of quality which is why it is important to make the distinction in a competitive and rapidly adapting market.Which standards to choose?As international regulatory regimes develop, so do barriers to trade as countries try to establish independent standards by which they regulate cannabis products.
The c in CGMP simply stands for “current”, and will employ only top-of-the-line manufacturing techniques. This distinguishing factor is important because good manufacturing practice ten years ago is not the same as good manufacturing practice in the present day. GMP vs CGMP at a glance. CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that.
In order to penetrate the highest value markets, companies must be able to meet global standards for production, quality management and analysis.Currently, the emerging EU cannabis market has led many firms to adopt EU-cGMP and ISO standards of quality. Mutual recognition agreements (MRA) for pharmaceutical cGMP between the EU and several other developed nations allow market access to international companies demonstrating adherence to these guidelines. So, which are the relevant standards and to what do they apply?EU-cGMP: Good Manufacturing Practicesfor pharmaceutical productsEU-cGMP provides a comprehensive structure for quality management, production and safety for pharmaceutical operations. This guideline enforces similar requirements to the WHO cGMP and FDA cGMP making it a strong reference for companies targeting international markets.ISO/IEC 17025; 2017: Generalrequirements for the competence of testing and calibration laboratories2017 guidelines are the benchmark for international laboratories by which they demonstrate technical competence. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others, use this document in confirming or recognizing the competence of laboratories.ISO/IEC 31000; 2018: Risk Management2018 guidelines provide principles, framework and a process for managing risk.
It can be used by any organization regardless of its size, activity or sector. Regulatory agencies have transitioned to a risk management-based approach to quality standards. As a result, companies that adopt ISO/IEC 31000: 2018 guidelines have a greater ability to navigate audits and mitigate risk factors that affect their bottom line.OutlookJurisdictional differences in regulations will continue to be a challenge for international cannabis companies, however, these challenges can be successfully managed though the adoption of recognized standards as an industry.
By building confidence that the cannabis sector can operate on the level of the pharmaceutical industry in terms of quality standards, MRAs and consumer demand will allow ease of movement through international markets. Companies that choose to adopt internationally recognized standards of quality will have the ability to establish a foothold in the global cannabis market. Those that do not will face mounting challenges in the face of an extremely competitive, fast moving industry and an increased burden of compliance as jurisdictional regulations struggle to catch up to global standards.References. WHO good manufacturing practices for pharmaceutical products: Main principles1 (Ser. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Doi:ISO/IEC (E) (3rd ed., 2017-11).
1-20, Tech.). London: Institute of Risk Management. (2019, July 16). Mutual recognition agreements (MRA). Retrieved from Bryan Goldner, Regulatory Manager – LATAM, TheraCann International.
Companies can typically choose whether to implement ISO standards. In some cases, however, governments adopt standards into legislation. For example, Australia has made compliance with ISO 8124.1:2002 mandatory for companies that manufacture or sell certain types of toys to young children. Compliance with GMP is always mandatory; its regulations have the force of law. If a company fails to meet its obligations, the FDA can recall and seize products or shut down facilities. If the Department of Justice becomes involved, companies may have to pay fines or face criminal liability prosecution. Geographical Reach.