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Showing posts from January, 2020

GMP Certification requirement based on WHO

What is GMP Certification? Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process ...

Health Safety & Environment Management System

What is HSE-MS? HSE-MS (Health Safety & Environment Management System) is set of Guideline developed for considering environmental protection, Occupational Health and Safety at work as important as providing quality products. Normally department focus on Quality and Products, but HSE specifies that Health and Safety management must be implied in organization, special for the Chemical Industry. Background of HSE:  HSE MS came into the picture after few serious incidences were occurred in chemical industry like  Bhopal disaster (India) (1984) and Seveso disaster (Italy) (1976)  due to failure of the Management System. Bhopal Disaster (India) 1984:  Bhopal Gas Tragedy was world's worst industrial disaster, a gas leak incident, which happen in heart of the India and killed approximately 3,787 to 19,000+ people which happen on 2–3 December 1984 at the Union Carbide India Limited (UCIL) pesticide plant in Bhopal, Madhya Pradesh, India. This loss can nei...

ANTI-BRIBERY MANAGEMENT SYSTEM

ANTI-BRIBERY MANAGEMENT SYSTEM LEAD AUDITOR TRAINING A well-managed organization is expected to have an agreement plan supported by right management systems to assist it in complying with its legal obligations and commitment to integrity. An anti-bribery policy is a component of an overall compliance policy. The anti-bribery policy and supporting management system helps an organization to let alone or moderate the costs, risks and damage of involvement in bribery, to promote trust and self-confidence in business dealings and to improve its reputation. This document reflects worldwide good practice and can be used in all jurisdictions. It is applicable to small, medium and large organizations in all sectors, including public, private and not-for-profit sectors. The bribery risks facing an organization vary according to factors such as the size of the organization, the locations and sectors in which the organization operates, and the nature, scale and complexity of the organization...

Business Continuity Management System Training Program

Course Description BCMS (Business Continuity Management System) 22301:2012 Lead Auditor Training is a 5-day instructor-lead course. The course is constructed around a case study and each activity is applied to the case study as we move through the course. There are more than 25 auditing activities as well as multi-media that provide practice applying and gain in an understanding of the requirements of ISO 22301 and BCMS auditing practices. Also included are small “quizzes” taken during the course after each section. The purpose of the quizzes is to help attendees measure what they know and what requires further study. What is Training Objectives? ISO 22301 refresh/review the structure & requirements of ISO 22301:2012.To enable delegates understand Key concepts in Business Continuity Management System auditing. To impart/enhance practical auditing skills to become internationally recognized certified Auditor/Lead Auditor. To enable the delegates to plan, conduct & m...

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organizatio...

ISO 14001 Certification Environment Management Systems

 Environment Management Systems Certification ISO 14001-2004 is an obsolete Standard, this certification is not in operation and any certificate issued under this standard is void now. New version of the Environmental Management System is ISO 14001:2015. ISO 14000 refers to a family of standards including ISO 14001, 14004, 14005 among others. The ISO 14001 standard deals with the environmental management system requirements; ISO 14001:2004 certifications are intended for any organization whose processes impact the environment. The standard lists requirements related to environmental policy, establishment of relevant legal and regulatory requirements and checking and corrective action and 14005 gives guidelines for phased implementation for an environmental management system and include the use of environmental performance evaluation. Certifications are issued by third party certifying bodies. Annual or regularly scheduled audits will be conducted to evaluate the organizat...
ISO 9001:2008 Certification     Introduction of ISO 9001 Certification ISO 9001 Certified is a common word we hear as Customer, what is the meaning of ISO 9001? ISO 9001 Certified means an organization has met the requirements in ISO 9001 and has received third party certification for such demonstration. It defines an ISO 9000 Quality Management System (QMS). ISO 9001:2008 is focused on meeting customer expectations and delivering customer satisfaction so you must pay attention to the customer “Quality Management System is appropriate and effective, while forcing you to identify and implement improvements Continuous improvement assures your customers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. Internally, the organization will profit from increased job satisfaction, improved morale, and improved operational results. Meeting legal and regulatory requirements benefit the community.” ISO 9001-2008 ...