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GMP (Good Manufacturing Practice) is the part of quality assurance that ensures consistent quality standards in the production and testing of medicinal products or active ingredients (APIs). This is a short excerpt from the eLearning course on GMP basics Human health is the primary concern. In everyday life, patients must feel they can rely on the high quality of a medicinal product, as they cannot check this themselves. The quality of a medicinal product is determined above all by the following factors: Identity (are the specified ingredients contained?) Content (are the ingredients present in the specified quantity?) Purity (is the product free of ingredients that do not belong in it?) The EU Guidelines to Good Manufacturing Practice require that “The holder of a Marketing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate  and do not place patients at risk due to inadequate safety, quality of efficacy.”This must be proven to the competent authority, which grants approval for the medicinal product, because: without marketing authorisation, a medicinal product may not be marketed to patients. How can these requirements therefore be met? And: how can consistent quality be ensured if it is not possible to individually test each tablet that is pressed? This is the purpose of good manufacturing practice.The principles of good manufacturing practice apply to almost all areas of a company, from research and development to production, quality control, storage and distribution. Anyone who manufactures, tests, stores or markets medicinal products or APIs on a commercial basis must therefore implement a series of defined requirements. The basic principle is that companies must manufacture medicines in such a way that they are suitable for their intended use. The basis for GMP requirements is the CGMP (Current Good Manufacturing Practice) Guide, which the U.S. Food & Drug Administration (FDA) published in the Federal Register in 1978. With this, the authority had created the world's first legally anchored GMP regulations. These made it possible for the manufacturing processes of pharmaceutical companies to be monitored by a regulatory authority.   However, the topic also gained importance internationally: In Germany, for example, the German Medicines Act (AMG) was published in 1978 as a direct result of the thalidomide scandal. However, it did not yet contain any specific GMP requirements. It was not until 1985 that the “Pharma-Betriebsverordnung” was published. For the first time, this contained concrete GMP specifications for Germany, which formed the basis for GMP monitoring through inspections by the responsible authorities. It took another four years before the EC GMP Guidelines, which are binding for Europe, finally appeared in 1989. According to the German AMWHV §2, the guideline is now called the EU GMP Guideline and has been legally valid in Germany since 2005, which means that compliance with its specifications must be documented. What are GMP rules?GMP rules are the requirements for quality assurance of the manufacturing processes and environment formulated by the European Commission in the principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use and active pharmaceutical ingredients. The EU GMP Guide describes how these rules are to be interpreted in Part I for medicinal products and in Part II for active substances, as well as in various annexes for specific product groups. 

For obtaining ISO 14001 Certification Auditing service, you can contact us anytime. This standard specifies requirements for an environment management system for any organization. It aims to demonstrate its conformance to legal and regulatory requirements. ISO 14001 Certification Auditing service takes into account significant impact management, environmental risks management and optimum utilization of resources. Thousands of clients have Benefits with our ISO 14001 Certification Auditing service and the next one could be you.   Benefits : Improved operational efficiency Enhanced customer trust / Confidence / Satisfaction Compliance of govt./ Regulatory controls. Improved operational efficiency Improved emergency situation handling preparedness Improved staff morale and work environment Access to international markets Increased safety / Less accidents/ Optimum utilisation of resources Reduction in Cost / Wastages

Internationally recognized ISO 9001 2015 standard is dedicated to Quality Management System (QMS). Quality Management System ISO 9001 Certification develops quality and boost performance & efficiency of a company. QMS certification i.e. ISO 9001 certification 2015 relies on principles of quality management such as a robust customer centric focus, the motivation and implication of top management and continuous improvement.

In a dynamic and competitive business environment, the health and safety of an organization’s workforce play a pivotal role in ensuring its success. ISO 45001, the Best ISO 45001 Certification in India, is an internationally recognized standard that sets the framework for a robust Occupational Health and Safety Management System (OHSMS). It’s designed to help organizations across the globe improve the safety and well-being of their employees, enhance workplace conditions, and achieve continuous excellence in occupational health and safety. The ISO 45001 standard represents the latest evolution of occupational health and safety management practices, emphasizing a holistic approach that integrates safety into every facet of an organization. ISO Certification Company, SQC Certification Services, is your trusted partner in navigating this journey towards occupational health and safety excellence in Delhi, Mumbai, Pune. What is ISO 45001:2018 Occupational Health and Safety Management System?   ISO 45001:2018 Occupational Health and Safety Management System is a globally acknowledged standard that outlines the requirements for establishing, implementing, and continually improving an OHSMS within an organization. This standard offers a systematic approach to managing safety processes, ensuring that an organization consistently provides a safe and healthy working environment for its employees. The ISO 45001 Health & Safety Management System focuses on key areas such as leadership, risk-based thinking, process approach, and continuous improvement. It serves as a solid foundation for organizations to enhance the safety of their employees, minimize occupational health risks, and maintain a people-centric approach to business operations. SQC Certification Services, the Best ISO 45001 Certification in India, can guide you through the process of implementing and achieving ISO 45001 certification, helping you leverage the full potential of this globally recognized standard in Delhi, Mumbai, Pune.

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