Risk assessment to patients in the absence of complete USP ⟨797⟩ protection

Dangerous Connections: Healthcare Community Tackles Tubing Risks

Manual for reporting on zoonoses and zoonotic agents, within the framework of Directive 2003/99/EC, and on some other pathogenic microbiological agents for information deriving from the year 2016

During the survey of substandard medicines in Cambodia in 2007, it was found that more than 90% of 500-mg amoxicillin (AMPC) capsules failed the United States Pharmacopeia (USP) 30 TEST 1 dissolution test. In the USP, several monographs provide multiple methods for performing the dissolution test. By using the 500-mg AMPC capsule as an example, we aimed to identify the problems and implications of the USP methods adopted for the dissolution test as a global standard. All AMPC samples were collected from the Cambodian market in 2007. For the quantitative test, we referred to USP 30. We performed the USP 28 and USP 30 TEST 2 dissolution tests and compared these results with those of the USP 30 TEST 1. All 500-mg AMPC capsules used for the comparison passed the quantitative test. Samples that passed the USP 28 and USP 30 TEST 2 dissolution tests were identical, and the pass rate was 97.1% (34/35), whereas the pass rate with the USP 30 TEST 1 was 8.6% (3/35). The difference in the dissolution results between the three methods was significant (P<0.0001). This study revealed that many users would select the most stringent method when multiple methods exist in the USP. This may lead to a high failure rate of the tests. Because USP is a global standard, we recommend that it take into consideration the developing countries and create a more detailed user-friendly manual for selection for appropriate methods.

Certification to the internationally accepted ISO Series 9000 quality standards is perceived as being compulsory for companies wishing to participate in the "Harmonized Europe," which is to be effective Jan. 1, 1993. Universally, the demand for certification to ISO 9000 has grown tremendously in recent years. This demand has created a quasi-partnership between the certified company and the certifying agency, both of which have progressed steadily up the learning curve in the implementation and maintenance of an accredited quality program. This paper describes the certification (registration) process from the vantage point of both a registered company and the certifying agency. The establishment of a procedure structure will be discussed, along with the document preparation and review, common oversights, the initial registration audit and the renewal audits. The tangible benefits derived from ISO certification, such as less nonconformance, identification of areas needing improvement and the company-wide culture change it fosters also will be examined. The role of ISO certification in laying the groundwork for a Total Quality Management (TQM) program will be discussed.

Proposed technical specifications for a survey on Listeria monocytogenes in selected categories of ready‐to‐eat food at retail in the EU

Manual for Reporting on Zoonoses, Zoonotic Agents and Antimicrobial Resistance in the framework of Directive 2003/99/EC and on some other pathogenic microbiological agents for information derived from the year 2012

In the course of 2007 the Standard ISO 19901-6 "Marine Operations" is expected to be published as a final ISO document. This Standard is a part of the series on Standards for Petroleum and Natural Gas Industries - Specific Requirements for Offshore Structures - Part 6: Marine operations. The Standard comprises a wide field of marine operations, which due to their special nature and limited duration are not always logically and adequately covered by other standards. The Standard provides requirements and guidance for the planning, engineering and safely execution of marine operations for all types of offshore structures except for drilling rigs. The paper explains the organization of the concerned part of ISO being ISO TC67/SC7 and indicates where the position of this Standard ISO 19901-6 is in comparison with other Standards of the series of ISO Standards Petroleum and natural gas industries - specific requirements for offshore structures (published, to be published and under preparation). The paper will focus on the key and operational parts of the Standard 19901-6 "Marine operations". The key parts are the general considerations on the HSE plan, risk management, job safety analysis, environmental impact study, and on manning, qualifications, job and safety training. Further key parts are Organization, documentations and planning, Metocean criteria, Weight control, Stability and Ballasting operations. The operational parts give guidance and recommendations on Loadout, Transportation, Temporary mooring, Construction and outfitting afloat, Float-over topside installation, Pre-laid mooring including foundation, Offshore installation operation, Lifting operations and finally Decommissioning and removal. The paper will show the advantage of the present Standard on the guidance and recommendations on the marine operations for all offshore structures as will be used by the oil companies and contractors. Introduction In the late 1980 proliferation of national standards were perceived as a threat The EU tended to initiate European Standards and also initiatives from National Standards were noticed (CA, CN, ID, NO, UK). Perceived business need by the major international oil and gas companies and major oil and gas producer associations were:Offshore Projects as Global BusinessGlobal Standards for Global Projects. The ISO came with the initiative. ISO is a worldwide federation of national standards bodies (ISO member bodies). ISO agreed on the following objectives:Development of global standards for Petroleum IndustryUnder the International organization for Standardization (ISO). For this purpose the existing technical committee ISO TC67 "Materials, equipment and offshore structures for petroleum, petrochemical and natural gas industries" was reactivated. Under management of subcommittee SC7 "offshore structures" the global standards would be established. More information on the ISO TC67/SC7 for the new international standards for offshore structures is given for instance in [Ref. 1], [Ref. 2] and [Ref. 3]. These new standards for all types of offshore structures (except drilling rigs) are implemented in the ISO 19900 series. The new global standards are based on API RPs and other existing practices while the convergence should be found through harmonization with international practices as practical and possible.

Latex aeroallergen pollution in the operating theatre: should latex allergic patients be scheduled first?

Goal: This study investigated the effect of quality management systems (QMS), with an emphasis on International Organization for Standardization (ISO) standards, in enhancing operational performance within Nigeria's manufacturing sector. The primary objective is to examine how QMS frameworks, specifically ISO 9001, ISO 45001, ISO 14001, and ISO 31000 standards, influence key operational metrics, including efficiency, defect reduction, customer satisfaction, and process improvement. Methodology: This research used a quantitative method and regression analysis to analyze data from 320 manufacturing company employees in Southwest Nigeria. The data was collected through a structured survey of participants in the Nigerian manufacturing sector. Findings: Results revealed that operational performance is positively enhanced by the combined effect of the quality management metrics. However, ISO 31000 risk management practices show the strongest impact on the Nigerian manufacturing sector. The combined metrics, which incorporate ideas from ISO standards such as ISO 9001 (quality management), ISO 45001 (occupational health and safety), and ISO 14001 (environmental management), create a solid foundation for operational improvement. Limitations: This research is limited to the use of the cross-sectional method and centers on specific QMS practices. Implications: The implications of this study are significant for both practitioners and researchers in the field of quality management, particularly within the context of Nigeria's manufacturing sector. Originality: There have been previous studies that talked about the role of the quality management systems, however, none of them combined role played by ISO 9001, ISO 45001, ISO 14001, and ISO 31000. Moreover, the study served as an addition to the existing literature.

IntroductionThe COVID-19 pandemic has led to unforeseen and novel manifestations, as illustrated by the management of drug shortages through the development of hospital production of sterile pharmaceutical preparations (P2S). Visual...

As tobacco control efforts gain worldwide momentum, policy makers, scientists, and public health advocates are focusing on the development of an appropriate set of international standards to regulate tobacco products....

The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its "General Chapter <797> Pharmaceutical Compounding-Sterile Preparations", which set a more rigorous and enforceable standard for sterile compounding in the United States. To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. Part 1 of this series reports the survey methods and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments. Part 2 will report results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It will also highlight some of the key areas where there is considerable opportunity for improvement. This survey identified numerous deficiences in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.

The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its "General Chapter <797> Pharmaceutical Compounding-Sterile Preparations", which set a more rigorous and enforceable standard for sterile compounding in the United States. To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. The survey methods for this study and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments were reported in Part 1. Part 2 reports results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It also highlights some of the key areas where there is considerable opportunity for improvement. This survey identified numerous deficiencies in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.

Quality schooling has often been a subject of international concern. In an effort to meet government standards for federal funding, improve their performance, and obtain public trust, education institutions of all levels, in many countries are implementing the market-based ISO 9000 quality management system. ISO 9000 is an international quality management system created by the non-governmental organization, International Organization for Standardization (ISO). The literature surrounding ISO 9000 in education indicates that the application of this quality management system to education is debatable, the implementation process is time-consuming and difficult, and that the subject is understudied. While there have been numerous case studies on ISO 9000 in education, this was the first study to use quantitative survey research methods to examine and compare ISO 9000 implementation in education institutions in two different countries, the United States and England. Interestingly, US and English institutions turned out to be very much the same with regard to ISO 9000. For example, US and English education institutions have a similar time to ISO 9000 registration, define their customer, stakeholder, suppliers, and partners in the same manner, and are implementing ISO 9000 for similar reasons.

The International Organization for Standardization (ISO) has published ISO 17034:2016 on the general requirements for the competence of reference material producers (RMPs). Previously, these requirements were addressed in ISO Guide 34:2009, originally developed by the ISO Committee on Reference Materials (ISO/REMCO). The need for an International Standard was triggered as several accreditation bodies could not accredit to a guide, at all, while in other countries ISO Guide 34 could only serve as accreditation standard in combination with ISO/IEC 17025. For the transformation into a conformity assessment standard of the ISO/IEC 17000 series, the ISO Committee on Conformity assessment (ISO/CASCO) and ISO/REMCO joined forces. A Joint Working Group, formed by experts and stakeholders from both committees, finalised the transformation within 2 years. During the transformation, the structure of ISO 17034 has been aligned with other ISO/IEC 17000 series standards and the content of ISO 17034 has been harmonised with the recent editions of other relevant ISO Guides. Requirements for the production of reference materials (RMs) were elaborated on more clearly in the new standard, specifying the requirements for (non-certified) reference materials and the additional requirements for certified reference materials. The new International Standard ISO 17034:2016 supersedes ISO Guide 34:2009.