GMP (Good Manufacturing Practices) is a set of legal guidelines that have been regulated by WHO (World Health Organization) since 1975. These aim to ensure that drugs and other pharmaceutical products are safe and effective. Since then, GMP has been considered a seal of quality for pharmaceutical products. GMP have been adopted by many countries worldwide and that includes India which is now the second largest producer of pharmaceutical products in the world.
Benefits of GMP Certifications
•Enhances the food safety management system
•Increases consumer confidence in your products
•Helps to decrease operating costs due to rework and penalties due to non-compliance
•Helps boost export opportunities.
•Reduced duplication of inspections
(GHP-Good Hygiene Practice )'Hygiene Verified' approval scheme For companies that do not have internal processes for independently measuring and managing good hygiene practices, Acascert has pioneered a global hygiene audit system - the 'Hygiene Verified' approval scheme. 'Hygiene Verified' is a global, independent scheme for food & pharmaceutical businesses focused on delivering measurable improvements in food safety operating standards, good hygiene practices and complying with national and international food hygiene regulations.
Benefits of 'Hygiene Verified' approval scheme
Compliance with law
Reduced consumer complaints
And for those involved in production, good working condition
Good Laboratory Practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
•ISO 13485/13488 is a quality standard for organizations that design, develop, produce or service medical devices. It is intended to promote harmonization in the medical device industry and set a basis for quality system regulations world-wide. It includes specific requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate to the medical device industry. All requirements of ISO 13485/134588 are specific to organizations providing medical devices, regardless of the type or size of the organization. Benefits of ISO 13485 :
ISO 13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale.
A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance.
It incorporates many of the quality management principles and delivers the benefits of an ISO 9001:2000 based quality management system.
Creates a competitive advantage. » Ensures a consistent and effective approach to business management.
Reduces risk factors via the use of risk management techniques. » Engages top management involvement.
Provides a robust framework for assuring product consistency
ISO 15378:2011 Primary packaging materials for medicinal products , the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
•ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. •ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes. Provides a robust framework for assuring product consistency.
•ISO 15189 Medical laboratories — Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories for the competence of testing and calibration laboratories •. While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.
Benefits of ISO 15189 :
Improved national and global reputation and image of the laboratory.
Continually improving data quality and laboratory effectiveness.
Having a basis for most other quality systems related to laboratories, such as Good Laboratory Practices.
Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.
Customer satisfaction is achieved through introduction of Quality Management System which is a part of ISO 15189.
All test equipment will be calibrated and traceable to National Standards so that accuracy of results will be ascertained & maintained.
Laboratory will be participating in Inter laboratory Comparison program so that quality level of the lab with respect to other accredited lab can be determined.
Quality control checks will be carried out periodically by which system is always maintained.
National and international recognition (eg CTs)
Assurance to clients of good laboratory practice
Meets purchaser or regulatory specifications
Decision makers can rely on test results
Improves staff motivation and esteem
Ensure better support in the event of legal challenge
Saves money by getting it right the first time
The ISO/TS16949 is an ISO technical specification aiming to the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 and the first edition was published in March 2002 as ISO/TS 16949:2002. Whether this will improve the quality of automobiles remains unclear. If the specification meets the promises of its proponents, then we should expect declining number of recalls, with statistical significance, over the next years.
ISO 26000 - Social responsibility
•Business and organizations do not operate in a vacuum. Their relationship to the society and environment in which they operate is a critical factor in their ability to continue to operate effectively. It is also increasingly being used as a measure of their overall performance. •ISO 26000 provides guidance on how businesses and organizations can operate in a socially responsible way. This means acting in an ethical and transparent way that contributes to the health and welfare of society.
ISMS -ISO 27001
ISO/IEC 27001 is the formal standard against which organizations may seek independent certification of their Information Security Management Systems (meaning their frameworks to design, implement, manage, maintain and enforce information security processes and controls systematically and consistently throughout the organizations). The standard covers all types of organizations (e.g. commercial enterprises, government agencies and non-profit organizations). It specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving documented ISMS within the context of the organization’s overall risk management processes. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof.ISO/IEC 27001 provides an ISMS model for adequate and proportionate security controls to protect information assets and give confidence to interested parties.
ISO 22301:2012: Societal security -- Business Continuity Management Systems
ISO 22301:2012 specifies requirements to plan, establish, implement, operate, monitor, review, maintain and continually improve a documented management system to protect against, reduce the likelihood of occurrence, prepare for , respond to, and recover from disruptive incidents when they arise.
ISO 28001:2007: Security Management Systems for the Supply Chain
ISO 28001:2007 provides requirements and guidance for organizations in international supply chains to
Develop and implement supply chain security processes;
Establish and document a minimum level of security within a supply chain(s) or segment of a supply chain;
Assist in meeting the applicable authorized economic operator (AEO) criteria set forth in the World Customs Organization Framework of Standards and conforming national supply chain security programmes
Benefits of ISO 28001:2007
ISO 28001:2007 establishes certain documentation requirements that would permit verification,Users of ISO 28001:2007 will
Define the portion of an international supply chain within which they have established security;
Conduct security assessments on that portion of the supply chain and develop adequate countermeasurestgh
Develop and implement a supply chain security plan;
Train security personnel in their security related duties programmes
ISO 30000:2009: Ships and marine technology - Ship recycling management systems
ISO 30000:2009 specifies requirements for a management system to enable a ship recycling facility to develop and implement procedures, policies and objectives in order to be able to undertake safe and environmentally sound ship recycling operations in accordance with national and international standards. The management system requirements take into account the relevant legal requirements, safety standards and environmental elements that the ship recycling facility needs to identify and comply with in order to carry out safe and environmentally sound ship recycling.
ISO 30000:2009 is applicable to any ship recycling facility that wishes to:
Establish, implement, maintain and improve a safe and environmentally sound management system for the recycling of ships;
Assure itself of conformity with its stated safe and environmentally sound management policy;
Demonstrate conformity with ISO 30000:2009
Making a self-determination and self-declaration, or
Seeking confirmation of its conformance by parties having an interest in the facility such as customers, or
Seeking confirmation of its self-declaration by a party external to the organization, or
Seeking certification/registration of its management system.
ISO 50001:2011:Energy management systems
Requirements and benefits of using an energy management system based on the ISO 50001 standard,an experienced instructor will discuss the requirements outlined in ISO 50001 and explain how developing and systematically managing policies and procedures can improve energy efficiency, help to achieve targets, and reduce energy costs. Moreover, the course will highlight the value of integrating ISO 50001 with other management systems, such as ISO 14001.