Skip to main content

Industrial Environmental Management Systems

BayBiotech.NET
Environmental Management Systems (EMS) can be considered as a tool to manage the environmental quality policies and procedures as per Industry standards and regulatory guidelines. EMS provides a framework to efficiently operate organizational responsibilities and activities in most efficient ways keeping the risk to the environment at its minimum. EMS also provides scope to the organization to implement corrective and preventive plan in order to continuously improve the environmental performance. An effective management system ensures that adequate efforts are properly deployed in regard to training, monitoring and reporting.

Three main environmental guidelines that fall within the scope of Biotech/ Life Sciences Industry and will need integration with EMS are:

RC14001: Responsible Care® (RC) is a voluntary initiative of the worldwide chemical industry with a focus on an on-going efforts to improve the safety and the protection of health and the environment, applicable not only to the organization but to the entire supply chain. The program was first introduced in 1988 by the American Chemistry Council (ACC) to address public concerns about the manufacture and use of chemicals and so far has been adopted in over 45 countries. To further strengthen the program,
ACC integrated the Responsible Care® requirements into the globally accepted Environmental Management Standard, ISO 14001.Responsible Care® principles in some form or other have been long adopted by leading organizations in the chemical industry. (http://www.techstreet.com/)
OHSAS18001: OHSAS 18001 standards were created by concerted efforts of the world’s leading national standards bodies, certification bodies, and specialists for occupational health and safety standards. The OHSAS specification is applicable to any organization that wishes to establish an OH&S management system to eliminate or minimize risk to employees and other interested parties who may be exposed to OH&S risks associated with its activities and provides guidelines to implement maintain and improve an OH&S management system.( http://www.osha-bs8800-ohsas-18001-health-and-safety.com/ohsas-18001.htm)
ISO14001: The ISO 14000 family addresses various aspects of environmental management. The very first two standards, ISO 14001:2004 and ISO 14004:2004 deal with environmental management systems (EMS). ISO 14001:2004 provides the requirements for an EMS and ISO 14004:2004 gives general EMS guidelines.
 ISO 14001:2004 provides a generic requirement for an environmental management system. The underlying philosophy is that whatever the organization's activity, the requirements of an effective EMS are the same, whereas:
 ISO 14004:2004 provides guidelines on the elements of an environmental management system and its implementation, and discusses principal issues involved. (http://www.iso.org/)

Comments

Popular posts from this blog

ISO Management Standards for Medical Devices

Two main ISO standards that have a direct application to Medical Device Industry are ISO 9001 and ISO 13485. While ISO 9001 is for evolving a Quality Management System for an organization, ISO 13485 has a direct application to Medical Device Industry. Although, ISO standards for a company are not a legal requirement, but provide a validation and ease of global marketing of the product.

eCTD Submission Specifications

BayBiotech.NET The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration. Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling. In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for hum

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of