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Quality Assurance and Compliance: Industrial Environmental Management Systems BayBiotech.NET

BayBiotech.NET AERS is a computerized information database designed to support FDA’s post marketing safety surveillance program for drug and biological products. The AERS database is used to store and analyze data received in post marketing safety reports submitted in form of reports by companies. FDA recently proposed to submit the reports in electronic format in order to achieve the following objectives: 1. Eliminate the time and costs associated with submitting paper reports. 2. Expedite the agency’s access to safety information 3. Enhance agency’s ability to rapidly communicate information about suspected problems to health care providers, consumers, applicants, and sponsors within the United States and internationally. The proposal is developed considering international standards guidelines (ICH) and was open for public comment between August- November, 2009. To read more about the proposed rules follow the link: http://edocket.access.gpo.gov/2009/pdf/E9-19682.pdf

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, applic

BayBiotech.NET The Health Information Technology for Economic and Clinical Health Act ( HITECH), intended to promote adoption of information technology for maintenance of electronic health records and incorporated into the American Recovery and Reinvestment Act of 2009, was signed into law on Feb. 17, 2009. The key points of the provisions are: 1. Tracking the medical information disclosure: According to the new legislation, physicians will be required to track any disclosure of a patient's medical information. Previously regulations allowed physicians to disclose patient information for the purpose of treatment, billing or health care, but they were not required to track when that information was disclosed. This provision kicks in for current users on Jan. 1, 2014, and then patients will be able to request an accounting of disclosures of their electronic personal health information three years from the date of the request, potentially dating back to 2011. 2. Rules regarding s

BayBiotech.NET When ICH was conceived in 1999, it was for a good cause understanding that it will have harmonization on guidelines for conduct of a clinical trial worldwide as it brought together European Union, United States and Japanese experts together to draw a set of standards that would streamline the clinical research globally. Out of thirty-eight topics (Guidelines) originally identified, only the ICH E6 document relates to the standards of Good Clinical Practice. Since, the EU Directive were set in place for conducting a clinical trial in UK and European member states it is not only ICH E6 but also EU GCP Directive 2001/20 and 2005/28 that is required to be followed which gives a higher standard than ICH E6 alone. Apart from these directives, member states of the European States have their local laws that are also incorporated into the GCP conducts. This further complicates the conduct of clinical trials and acceptance of global data because if a member state selects a site

BayBiotech.NET Performing site visits to your CROs for compliance audits at certain time intervals ensures the integrity and quality of data you are receiving for the clinical research. Sponsor audits also set stage for engaged CROs to prepare for direct FDA audits and leads to increased chances of success. Audits may be either routine audits to check the facilities for compliance or may be based on the performance or any non-compliance issue that may have come in the highlight during the course of the study. In either case an audit provides CROs with timely opportunity to take corrective and preventive action measures and makes the CRO facility aware of sponsor’s vigilance leading to compliance on their part as well as best outcomes of financial investment for the sponsor. Before performing an audit, an audit plan must be drafted by the auditor specifically preparing a check list of the items or issues that are recognized as critical steps of the procedures performed at CRO sites.

BayBiotech.NET A quality management system (QMS) is a collective term for a management framework comprising of policies, plans, practices, and the supporting infrastructure by which an organization aims to reduce, eliminate and maintain non-conformance to specifications, standards, and customer expectations in the most cost effective and efficient manner. Quality management systems are relevant especially for healthcare/ Biotech/Pharmaceutical industry that are regulated by FDA. All organizations whether large or small, public or private, manufacturing or service oriented are benefited by implementing a quality management system. Although a small company may have an in-house developed QMS system to manage the compliance and meet the production specifications for internal as well as external regulatory requirements, eventually it becomes difficult to manage the same in larger companies or multinationals. As it is obvious that for best results QMS must be implemented globally in an or