Preview only show first 10 pages with watermark. For full document please download

Iso 9000 & Its Importance In Pharmacy

ISO 9000 & Its Importance in Pharmacy

   EMBED


Share

Transcript

  Journal of Pharmacy Research Vol.5 Issue 8.August 2012 Vishal Sachdeva et al. / Journal of Pharmacy Research 2012,5(8),4108-4112 4108-4112  Review ArticleISSN: 0974-6943 Available online throughwww.jpronline.info *Corresponding author. Vishal Sachdeva 106-A, Setia Colon St. No. 3 Sri Ganganagar (Rajasthan) India, 33500  INTRODUCTION ISO (International Organization for Standardization) is the world’s largestdeveloper and publisher of International Standards .ISO is a network   of the national standards institutes of 162 countries ,one member per country, with a Central Secretariat in Geneva, Switzerland,that coordinates the system.ISO is a  non-governmental organization  that forms a bridge betweenthe public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or aremandated by their government. On the other hand, other members havetheir roots uniquely in the private sector, having been set up by national partnerships of industry associations.Therefore, ISO enables a consensus  to be reached on solutions that meet both the requirements of business and the broader needs of society.ISO’s NAME Because “International Organization for Standardization” would havedifferent acronyms in different languages (“IOS” in English, “OIN” in Frenchfor Organisationinternationale de normalisation ), its founders decided togive it also a short, all-purpose name. They chose ”ISO” , derived from theGreek isos ,  meaning “equal” . Whatever the country, whatever thelanguage, the short form of the organization’s name is always ISO. Why Standards matter Standards make an enormous and positive contribution to most aspects of our lives.Standards ensure desirable characteristics of products and services such asquality, environmental friendliness, safety, reliability, efficiency andinterchangeability - and at an economical cost. ISO 9000 & its Importance in Pharmacy Vishal Sachdeva*, Vipin Kukkar, Vikram Jeet Singh, Shishir Jha Seth G. L. Bihani S. D. College of Technical Education (Institute of Pharmaceutical Sciences & Drug Research)Gagan Path, Sri Ganganagar (Rajasthan) 335001, INDIA Received on:14-05-2012; Revised on: 16-06-2012; Accepted on:27-07-2012  ABSTRACT ISO 9000 Quality Management System is a structural framework of a business system that specifies, in very broad terms, the necessary components of a quality management system. Subjective studies suggest that ISO 9000 can help organizations improve their management practices. In this paper, theresearcher examined the effectiveness of the ISO 9000 certification, and tested whether earning the ISO 9000 certification leads to improvement in qualitymanagement practices, in medication management practices, and in organizational management systems in health care setting. Overall, this study presentsISO 9000 Quality Management System as effective in improving the pharmacy management systems. A well documented and consistent ISO 9000Quality Management System can contribute significantly to improve performances in health care setting. Key words:  ISO, Quality Management, Pharmacy.When products and services meet our expectations, we tend to take this for granted and be unaware of the role of standards. However, when standardsare absent, we soon notice. We soon care when products turn out to be of  poor quality, do not fit, are incompatible with equipment that we alreadyhave, are unreliable or dangerous.When products, systems, machinery and devices work well and safely, it isoften because they meet standards. And the organization responsible  for many thousands of the standards which benefit the world is ISO . Who Standards BenefitISO standards provide technological, economic and societal benefits. For businesses , the widespread adoption of International Standards meansthat suppliers can develop and offer products and services meetingspecifications that have wide international acceptance in their sectors.Therefore, businesses using International Standards can compete on manymore markets around the world.For innovators  of new technologies, International Standards on aspectslike terminology, compatibility and safety speed up the dissemination of innovations and their development into manufacturable and marketable products.For customers , the worldwide compatibility of technology which is achievedwhen products and services are based on International Standards gives thema broad choice of offers. They also benefit from the effects of competition  among suppliers.For governments , International Standards provide the technological andscientific bases underpinning health, safety and environmental legislation.For trade officials , International Standards create ”a level playingfield”  for all competitors on those markets. The existence of divergentnational or regional standards can create technical barriers to trade.International Standards are the technical means by which political tradeagreements can be put into practice.  Journal of Pharmacy Research Vol.5 Issue 8.August 2012 Vishal Sachdeva et al. / Journal of Pharmacy Research 2012,5(8),4108-4112 4108-4112  For developing countries, International Standards that represent aninternational consensus on the state of the art are an important sourceof technological know-how. By defining the characteristics that productsand services will be expected to meet on export markets, InternationalStandards give developing countries a basis for makingthe rightdecisions when investing their scarce resources and thus avoid squanderingthem.For consumers, conformity of products and services to InternationalStandards provides assurance about their quality, safety and reliability.For everyone, International Standards contribute to the quality of life ingeneral by ensuring that the transport, machinery and tools we use are safe.For the planet we inhabit, International Standards on air, water and soilquality, on emissions of gases and radiation and environmental aspects of  products can contribute to efforts to preserve the environment. ISO 9000 Origin The story of ISO 9000 is a story of standards, methods and regulation. The brief history that follows is in no way comprehensive but is intended toillustrate four things ã that standards are an ancient concept that survived several millennia; ã that a means of verifying compliance often follows the setting of standards; ã that the formalizing of working practices is centuries old and seenas a means to consistently meet standards; ã that market regulation (relative to the standard of goods and ser-vices) has been around for centuries for the protection of bothcraftsmen and traders.ISO 9000 is a symptom of practices that were around centuries beforeanyone coined the term quality management. It is in some respects a natural progression that will continue to evolve. The story is told from a Britishviewpoint. How ISO Standars are developed? The national delegations of experts of a technical committee meet to discuss,debate and argue until they reach consensus  on a draft agreement. This iscirculated as a Draft International Standard (DIS) to ISO’s membership asa whole for comment and balloting.Many members have public review  procedures for making draft standardsknown and available to interested parties and to the general public. The ISOmembers then take account of any feedback they receive in formulatingtheir position on the draft standard.If the voting is in favour, the document, with eventual modifications,is circulated to the ISO members  as a Final Draft International Standard(FDIS). If that vote is positive, the document is then published as anInternational Standard.Every working day of the year, an average of eight ISO meetings are taking place somewhere in the world. In between meetings, the experts continuethe standards’ development work by correspondence. Increasingly, their contacts are made by electronic means and some ISO technical bodies havealready gone over entirely to working electronically , which speeds upthe development of standards and cuts travel costs . Popular Standards ISO 9000 Quality Management Systems - Fundamentals And VocabularyISO 9001 Quality Management Systems RequirementsISO 9004 Quality Management Systems-Guidelines For Performance ImprovementsISO 14000 Series on Environmental ManagementISO 19011 Guidelines for Quality and/Or Environmental Management Systems Auditing Types of ISO 9000What is the difference between ISO 9001 / 9002 / 9003?ISO 9001  Is the most complete and demanding standard in the ISO 9000 series. Itcovers product design, engineering,manufacturing, purchasing, marketing,sales, product storage, shipping and handling and product servicing. ISO 9002 is the next most demanding standard in the ISO 9000 seriesis designed to assure customers that the quality system is in place frommanufacturing to service. ISO 9003 is the least demanding standard in the ISO 9000 series.It addresses only the requirements for detection and control of problemsduring final inspection and testing of less complex products or services. ISO 9000 Series Quality Management SystemPrinciples 1 – CUSTOMER FOCUSED ORGANIZATION2 – LEADERSHIP3 -INVOLEMENT OF PEOPLE4 - PROCESS APPROACH5 - SYSTEM APPROACH TO MANAGEMENT6-CONTINUAL IMPROVEMENT7- ACTUAL APPROACH TO DECISION MAKING8- MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPSOn September 17, 1999, NASA became the first multi-site governmentagency in the world to achieve ISO 9001 registration status for all of itssites, fulfilling a goal set by NASA Administrator Daniel Goldin on November 13, 1996. ISO 14000  The ISO 14000 environment management standards exist to helporganizations minimize how their operations negatively affect theenvironment. ISO 14001 ISO 14001 is generic and flexible enough to apply to any organization producing any product or service anywhere in the world. ISO 14020 covers labels and declarations. ISO 14030 discusses post-production environmental assessment. ISO 14040 discusses pre-production planning and environment goal setting. ISO 9000 SERIES The ISO, based in Switzerland, first published the ISO 9000 standards in1987. The series was designed as a means to increase customer confidence  Journal of Pharmacy Research Vol.5 Issue 8.August 2012 Vishal Sachdeva et al. / Journal of Pharmacy Research 2012,5(8),4108-4112 4108-4112  in the quality of supplied materials, products, or services. This was especiallyimportant for trade between different countries with different languagesand cultures. Not surprisingly, the initial emphasis was within the EuropeanEconomic Community as part of the movement to a unified market. Thestandard has evolved over several revisions. The initial 1987 version, ISO9000:1987, although structured like the British Standard BS 5750, includednumerous documents then in use around the world. Although the Standardhas gone through two more iterations, which have resulted in some radicallychanged language, all the core, prevention-oriented quality assurancerequirements were present in the 1987 document. The language of this firstversion of the Standard was influenced by existing U.S. and other DefenceMilitary Standards (“MIL SPECS”), so was more accessible tomanufacturing, and was well-suited to the demands of a rigorous, stable,factory-floor manufacturing process. With its structure of twenty“elements” of requirements, the emphasis tended to be overly placed onconformance with procedures rather than the overall process of management,which was the actual intent.The 1994 version, ISO 9000:1994 emphasized quality management andquality assurance via preventive actions, and continued to require evidenceof compliance with documented procedures. Unfortunately, as with thefirst edition, companies tended to implement its requirements by creatingshelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. Adapting and improving processes could be particularly difficultin this kind of environment. The 2000 version, ISO 9000:2000 that consistsof ISO 9001:2000 and ISO 9004:2000, made a significant change by actually placing the concept of process management front and center in the Standard.There was no change in the essential goals of the Standard, which was allabout a “documented system,” not a “system of documents.” The goal wasalways to have management system effectiveness via process performancemetrics. The third edition makes this more visible and so reduced the emphasison having documented procedures if clear evidence could be presented toshow that the process was working well. Expectations of continual processimprovement and tracking customer satisfaction were made explicit at thisrevision. ISO 9000 has gained extensive acceptance, having been adopted by over 100 countries. Compliance is voluntary; however, some companieshave made certification a condition of doing business. The registration process involves independent audit and confirmation that quality systemsare in compliance with the standard. A fee is involved and periodicreinspection is required. A certificate of compliance is provided. This is theconverse of the U.S. GMP situation, where compliance is assumed unlessthe FDA states otherwise, and no certificate of compliance is provided.However, a major benefit of ISO 9000 has been to allow and encouragenonregulated industries to introduce a quality management system.Previously, the only widely established systems included regulations suchas GMPs aimed at specific industries and award programs such as Demingand Malcolm Baldrige. None of these had universal coverage, although theWorld Health Organization GMPs do apply to many countries. Since the pharmaceutical industryis already subject to quality regulations, attainingISO 9000 or 9001certification is not a goal of pharmaceutical manufacturers.However, suppliers to the pharmaceutical industry have sought it. Evolution of ISO 9000 Standards1987 version ISO 9000:1987 had the same structure as the UK Standard BS 5750, withthree ‘models’ for quality management systems, the selection of which was based on the scope of activities of the organization:ISO 9001:1987  Model for quality assurance in design, development, production, installation, and servicing   was for companies and organizationswhose activities included the creation of new products.ISO 9002:1987  Model for quality assurance in production, installation, and  servicing   had basically the same material as ISO 9001 but without coveringthe creation of new products.ISO 9003:1987  Model for quality assurance in final inspection and test   covered only the final inspection of finished product, with no concernfor how the product was produced.  ISO 9000:1987   was also influenced by existing U.S. and other DefenseStandards (“MIL SPECS”), and so was well-suited to manufacturing. Theemphasis tended to be placed on conformance with procedures rather thanthe overall process of management, which was likely the actual intent. 1994 version  ISO 9000:1994  emphasized quality assurance via preventive actions, insteadof just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, thedown-side was that companies tended to implement its requirements bycreating shelf-loads of procedure manuals, and becoming burdened with anISO bureaucracy. In some companies, adapting and improving processescould actually be impeded by the quality system. 2000 version  ISO 9001:2000  combined the three standards—9001, 9002, and 9003— into one, called 9001. Design and development procedures were requiredonly if a company does in fact engage in the creation of new products. The2000 version sought to make a radical change in thinking by actually placingthe concept of  process management front and center (“Process management”was the monitoring and optimisation of a company’s tasks and activities,instead of just inspection of the final product). The 2000 version alsodemanded involvement by upper executives in order to integrate qualityinto the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasksand activities. Expectations of continual process improvement and trackingcustomer satisfaction were made explicit.The ISO 9000 standard is continually being revised by standing technicalcommittees and advisory groups, who receive feedback from those professionals who are implementing the standard. 2008 version ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version onlyintroduced clarifications to the existing requirements of ISO 9001:2000 andsome changes intended to improve consistency with ISO 14001:2004. Therewere no new requirements. For example, in ISO 9001:2008, a qualitymanagement system being upgraded just needs to be checked to see if it isfollowing the clarifications introduced in the amended version.ISO 9000 has eight quality management principles on which the qualitymanagement system standards of the revised ISO 9000:2000 series are based. The principles are derived from the collective experience andknowledge of the international experts who participate in ISO TechnicalCommittee ISO/TC 176, quality management, and QA, which is responsiblefor developing and maintaining the ISO 9000 standards . The eight qualitymanagement principles are defined in ISO 9000:2000, Quality ManagementSystems Fundamentals and Vocabulary, and in ISO 9004:2000, QualityManagement Systems Guidelines for Performance Improvements. Acomparison to U.S. GMP is presented. Principle 1: Customer Focus Organizations depend on their customers and therefore should understandcurrent and future customer needs, should meet customer requirements and  Journal of Pharmacy Research Vol.5 Issue 8.August 2012 Vishal Sachdeva et al. / Journal of Pharmacy Research 2012,5(8),4108-4112 4108-4112  strive to exceed customer expectations.Customer focus is a critical businessfocus and is not covered in the U.S. GMPs other than the need to have products that meet the standards and specifications. Principle 2: Leadership Leaders establish unity of purpose and direction of the organization. Theyshould create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives. There isno mention of Leadership in the U.S. GMPs but the concept is included inthe Quality Systems Approach to Pharmaceutical GMP Regulations finalguidance, September, 2006 where providing leadership is the first item inthe management responsibilities section. Principle 3: Involvement of People People at all levels are the essence of an organization and their fullinvolvement enables their abilities to be used for the organization’s benefit.Responsibilities of the quality unit and personnel qualifications are coveredin the U.S. GMPs and the develop personnel concept is in the QualitySystems Approach guidance. Principle 4: Process Approach A desired result is achieved more efficiently when activities and relatedresources are managed as a process. Principle 5: System Approach to Management Identifying, understanding, and managing interrelated processes as a systemcontributes to the organization’s effectiveness and efficiency in achievingits objective. Principles 4 and 5 are not covered in the U.S. GMPs but theconcepts are implied in the Quality Systems Approach guidance. Principle 6: Continual Improvement Continual improvement of the organization’s overall performance should be a permanent objective of the organization. The closest thing to continualimprovement is the corrective and preventive action (CAPA) GMP practicesthat are typically the results of a failure investigation. Principle 7: Factual Approach to Decision Making Effective decisions are based on the analysis of data and information. The basis of science and supporting data is a fundamental expectation of theU.S. GMPs and quality by design (QBD) initiatives. Principle 8: Mutually Beneficial Supplier Relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. Controlof materials and components is a U.S. GMP requirement and qualityagreements and supplier contracts are expected practices but relationshipsare not a requirement. The Three Pillars of ISO 9000 ISO 9000 Certification is only of any value in markets where it provides theconfidence needed for free trade. ISO 9000 as a symbol has becomesynonymous with certification, quality management systems, documentationand internal audits to such an extent that if one were to dispense with ISO9000 certification, one also ceases to maintain a quality management system,ceases to conduct audits and ceases to use documentation. We have todivorce certification from systems and systems from standards and correcta few misconceptions. ISO 9000 Certification is optional and whether or not your organization is ISO 9000 certificated, it does not by itself affectthe performance of an organization. It is a flag of confidence that is visibleto others with whom you trade. Certification is inextricably linked to thestandard. ISO 9000 is a series of standards and their use is optional. Theydo not affect the performance of an organization although their use canassist organizations improve performance. The standards can be usedwithout being linked with certification.All organizations have a quality management system but its formalizationis optional. The system enables the organization to achieve its objectivesand therefore exists independently of whether or not ISO 9000 is used andwhether or not ISO 9000 Certification is obtained.Remove the two outer pillars and the organization remains stable! Thefoundation upon which the three pillars stand is the body of knowledgethat represents the field of quality management. Most of this knowledge ischannelled through the management system, somewhat less is channelledthrough the standard (ISO 9000) and a particular branch ofthe body of knowledge is channelled through certification. An organizationcould absorband apply all relevant knowledge and therefore obtain noadditional supportfrom ISO 9000 standards or ISO 9000 certification. Anotherorganizationmay absorb and apply some knowledge directly from thefoundation butrequire the support of the ISO 9000 standards to helpunderstanding andapplication. A third organization may absorb and applylittle knowledgedirectly from the foundation and require both the support ofthe ISO 9000standards and ISO 9000 certification to maintain a stable androbustmanagement system. (Hoyle D. 2001)Importance of ISO 9000 in PharmacyISO Gives Pharmaceutical industry new management tool to improvepatient safety The benefits of implementing Good Manufacturing Practices and qualitymanagement are henceforth made easier to achieve for the pharmaceuticalsector thanks to ISO.“The standard is of vital importance to the pharmaceutical industry and itssuppliers of pharmaceutical primary packaging materials. For the first time,the principles of Good Manufacturing Practice are specified as part of anISO standard.Good Manufacturing Practices (GMP) relate to quality control and qualityassurance enabling companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the customer from purchasing a product which is ineffective or even dangerous. Up until now, however, there was no applicable guidelineor rule for primary packaging materials, which contain, seal or are used for dose application and have direct contact with the medicinal product.The publication of ISO 15378:2006,  Primary packaging materials for medicinal products – Particular requirements for the application of ISO9001:2000 , represents an international consensus on good practice andestablishes a benchmark that can be applied for quality improvement,training, auditing and certification.Developed with the participation of pharmaceutical sector experts, ISO15378:2006 incorporates in a single document the quality managementrequirements of ISO 9001:2000 together with the Principles of GoodManufacturing Practice (GMP) for the design, manufacturing and supplyof primary packaging materials for medicinal products.In addition, the new standard gives guidance on risk management andvalidation and – in line with current developments worldwide – containsguidance annexes on both these aspects.The standard is applicable to all primary packaging materials (glass, rubber, plastic, aluminum, etc.).