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Pharmaceuticals

Under European and legislation, all medicinal products must be authorized before being placed on the market. Pharmaceutical companies and wholesalers must satisfy regulators that the manufacture, distribution, and supply of the medicine meet required safety and quality standards. BSI has a range of pharmaceutical standards and best practice guidance that help manufacturers achieve compliance and support improved business performance and resilience.

Pharmaceutical standards ensure patient safety

Discover how standards optimize time to market, whilst safeguarding patients and profitability

Cleanroom standards: Protecting your products and processes from contamination
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Cleanroom standards: Protecting your products and processes from contamination

In industries where the manufacture or handling of items such as medical devices and microelectronic products, requires high levels of contamination control and classification of even the smallest particle or airborne molecular contaminant - a pristine cleanroom environment is required. Cleanrooms are enclosed spaces where the air quality is managed to reduce dust, microbes, and other airborne contaminants to minimal levels. Products and processes that benefit from the control of airborne contamination include pharmaceuticals. Pharmaceutical manufacturing is always done in clean and controlled environments. Even the supply chain partners like those who supply packaging materials to pharma companies must maintain the highest standards in ensuring that the relevant hygiene, care, cleanliness, and microbe-free environment are present while producing such packaging materials. The three ways in which a cleanroom is clean are: The air quality is controlled All surfaces and equipment are always cleaned to a certain standard It is operated in a specific way — for example, the number of staff is limited To support the management and control of such environments, BSI has several standards that can help pharmaceutical organizations adopt cleanroom best practices. To read about clinical laboratories and testing, click here. Setting the Standard for Cleanroom Best Practices With pharmaceutical processes constantly evolving, the need for cleanrooms that can keep up with changing needs is crucial. BS EN ISO 14644-8:2013 Cleanrooms and associated controlled environments. Classification of airborne molecular contamination covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group, or category).  It provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification. Within this part of BS EN ISO 14644, the presence of airborne molecules is expressed as airborne molecular contamination (AMC). Molecular contamination is a three-step event. The first step is generation due to external sources, process leakage, construction, or human material outgassing. The second step is to transport as AMC in air. The third step is sorption on the sensitive surface, which can be quantified as a surface molecular contamination (SMC). BS EN ISO 14644-8:2013 is one of a series of standards concerned with cleanrooms and contamination control.  Many factors besides AMC need to be considered in the design, specification, operation, and control of cleanrooms and other controlled environments.  These are covered in some detail in other parts of the standard which include: BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments. Classification of air cleanliness BS EN ISO 14644-2:2015 Cleanrooms and associated controlled environments. Specifications for testing and monitoring to prove continued compliance with BS EN ISO 14644-1 BS EN ISO 14644-3:2019 Cleanrooms and associated controlled environments. Test methods BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Design, construction, and start-up BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments. Operations BS EN ISO 14644-6:2007 Cleanrooms and associated controlled environments. Vocabulary BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments. Separative devices (clean air hoods, gloveboxes, isolators, and mini environments. In your compliance-critical industry, ensure you are meeting the cleanroom standards. A BSI Knowledge subscription gives you instant access to the resources you need to effectively protect your products from contamination and build trust throughout your supply chain. Build your own custom collection of standards, or opt for access to one of our pre-built modules and keep up-to-date with any relevant changes to your standards strategy. Request to learn more. Ensure your cleanrooms and processes are operating to best practices by adding these standards to your collection today.Read more
The importance of digital innovation standards in pharmaceutical manufacturing
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The importance of digital innovation standards in pharmaceutical manufacturing

The Made Smarter Review estimated that the adoption of digital technologies by the medicines industry could be worth £22.4 billion over 10 years. Digitalization can help remove non-viable drug candidates from the development process much earlier, thus reducing time and costs to the industry. Additionally, digitalization would enable the transformation from large-volume manufacturing plants to more agile, localized, and smaller production facilities. This would lead to significant productivity improvements, estimated at 30- 35% by 2030. Digitalization will also create closer links with patients and clinics and give rise to better information for manufacturers. It will also speed up the rate at which clinical data are available, increasing its value significantly. Logistics will be improved, and companies will benefit from reduced waste via better inventory management. More broadly, the global pharmaceutical industry is estimated to be wasting 7-10% of the input materials, and this could be addressed by digitalization. Digitalization will enable continuous monitoring and adjustment, which will be particularly useful in cell and gene therapies where there are fewer starting materials to work from. What are the opportunities for digital innovation within pharmaceutical manufacturing? There are lots of opportunities where pharmaceutical manufacturing can embrace digital innovation in their practices. Short-term plans should focus on a shift from ad-hoc collaboration to more streamlined and efficient sharing of assets. Other opportunities include: There is a need to develop the entrepreneurial framework and ecosystem to support increased connectivity between companies. Policy interventions may be required at a European level to support this change. A legal framework is required to allow contracts to be rapidly set up between companies specific to manufacturing applications. There is a need for standardized data formats for interoperability between clients and service providers to facilitate a service based on data transfer. There is an opportunity to embrace the Factory of the Future (FoF) concept in pharmaceutical manufacturing. Bringing in new technologies around electronics, sensor technologies, robotic technologies. and through-life engineering. To read more about the BSI’s development of standards to meet these, and other industry innovation needs, download our brochure. How can adopting standards kickstart your organization’s innovation journey? Though there are a lot of opportunities for pharmaceutical manufacturers to embrace digital innovation, many companies are not structured to fully take advantage of them. Standards are a key tool for corporations to successfully manage innovation and survive in a fast-moving, highly complex global economy. They offer clear frameworks to help organizations create the right infrastructure for capturing and implementing ideas, understanding what works and what doesn’t, and maximizing value. The BS EN ISO 56000 series helps organizations introduce an innovation management system to identify the most important challenges, capture the right ideas, seize the best opportunities and properly manage emerging trends and risks. BS EN ISO 56002:2021 Innovation management system guidance gives guidance for businesses looking to adopt an innovation management system. BS EN ISO 56003:2021 Innovation management tools and methods for innovation partnership guidance gives guidance to organizations on the tools and methods for innovation partnership, supporting wider innovation training for staff, and provides guidance on how innovation partnerships are managed so that collaborative efforts become mutually beneficial. PD CEN ISO/TR 56004:2020 Innovation management assessment provides guidance on how organizations can carry out effective innovation management assessments and why it is important to manage innovation in a systematic manner. BS EN ISO 56005 Innovation management tools and methods for intellectual property management guidance provide guidelines for supporting the role of intellectual property within innovation management. Efficient management of the intellectual property is key to supporting the process of innovation, is essential for organizations' growth and protection, and is their engine for competitiveness.  Public document PD CEN/TX 16555 series (parts 2, 3, 4, and 6) should also be adopted by organizations wanting to embrace digital innovation. This technical specification series provides guidance on establishing and maintaining an innovation management system (IMS), including strategic intelligence, innovation thinking, intellectual property management, and creativity management. Management teams could also use BS EN ISO 44001 to further support collaborative business relationships. This standard offers specific guidance around knowledge sharing and managing joint objectives to build better relationships and improve innovative results. When preparing your business to adopt new digital technologies, it is also vital that you have a system in place to protect your organization’s information security. Protecting personal records and commercially sensitive information is critical. BS EN ISO/IEC 27001 helps you implement a robust approach to managing information security (infosec) and building resilience. The BS EN IEC 62443 series also helps organizations to adopt security best practices for industrial automation and control systems. Prepare your business for the digital innovations of tomorrow by adopting the above standards today. Discover BSI Knowledge As technology continues to advance rapidly in the pharmaceutical sector, accessing the standards your business needs to adapt to these innovations does not have to be complicated and time-consuming. Our tailored BSI Knowledge subscription service provides flexibility, access, visibility, and control over the standards and insights your team needs to adopt emerging processes. Request to learn more.
Good distribution practices for the pharmaceutical industry
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Good distribution practices for the pharmaceutical industry

Good distribution practices ensure maintaining product safety and quality during distribution across the supply chain and this practice is significant for the pharmaceutical industry. Good Distribution Practices (GDP) refers to a quality system for warehouses and distribution centers dedicated to medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. It ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants to the final shipment of finished drugs to the end-user. To read more about quality management in the pharmaceutical industry, click here. What are good distribution practices? Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines are maintained throughout the supply chain. Compliance with GDP ensures that: Medicines in the supply chain are authorized in accordance with European Union (EU) legislation. Medicines are always stored in the right conditions, including during transportation. Contamination by or of other products is avoided. An adequate turnover of stored medicines takes place. The right products reach the right addressee within a satisfactory time period. The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure. GDP also applies to the sourcing, storage, and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines. Challenges to achieving good distribution practices Managing the quality of medicines during distribution is a challenging operation. The challenges of the pharmaceutical products supply chain are due to its specified shelf life and storage conditions. The various dosage forms (e.g. tablets, syrups, injectables, etc.) are to be transported and stored under different environmental conditions hence all medicines cannot be handled with a general rule. viz the requirement of handling tablets, syrups, and injectables shall widely vary. The cold chain product range of medicines is stored at a temperature between 2 to 8 O C. For cold chain products, therefore the degree of carefulness shall be more due to the fear of product failures during quality control testing by customers. The GDP guidelines are intended to be applicable to all persons and outlets involved in any aspect of the storage and distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his or her agent. The COVID-19 Vaccine: Case Study of Distribution Challenges Drug and vaccine distribution visibility and risk management have long raised significant issues for the pharmaceutical sector. With global vaccination for Covid-19, the challenges are greater than ever. The vast demand for vaccines worldwide, coupled with constraints in qualified transportation availability and capacity, is placing intense ongoing pressure on the industry and its supply chain professionals. A consistently high standard of management is required to address distribution risks, including: Distribution delay - we need to act quickly to reach seven billion people as soon as possible Vaccine ineffectiveness - vaccines must be maintained at specific cold chain temperatures, from the point of manufacture to the point of the needle Insufficient qualified logistical capacity - from international air and ocean cargo to last mile, in-country transport provision Weak controls and assessment processes - due to the reduction of in-person auditing Uneven distribution - global access to vaccines is inequitable Crime - from theft, diversion, or counterfeiting of vaccines Increased costs and inefficiencies - due to new distribution network complexities Brand damage - end patient trust To address the complexities of global vaccine distribution, BSI can help you adopt best practices. Standards that support good pharmaceutical distribution practices The key standards to help pharmaceutical organizations implement good distribution practices are as follows: BS EN ISO 9001 Quality management systems help companies identify gaps in their good manufacturing practices, proactively mitigating risk before problems arise. Benefits of this standard include; helping to assess gaps in quality management systems to identify areas of higher risk, developing and implementing plans to remediate quality risks, and assisting in developing quality management systems to bolster compliance. BS ISO 28000 Risk management in supply chains enables organizations to understand hidden risks in their supply chain and equips them to handle unforeseen disruptions. This standard helps organizations to map risk across the supply chain, from API manufacturers to distributors and sites of care, develop and implement plans to respond to, and remediate supply chain risks (including manufacturing, in-transit, and distribution-related risks) and develop business impact analysis and business continuity plans. BS EN ISO 22301 Business continuity management standards help pharmaceutical organizations understand and prioritize the threats to their business with the international standard for business continuity. It specifies the requirements for a management system to protect against, reduce the likelihood of, and ensure your business recovers from disruptive incidents. Ensure your pharmaceutical organization is working to good distribution practices, by adding these standards to your collection today. Discover BSI Knowledge Want to access and manage the standards you need to ensure good distribution practices in your supply chain - all in one place? With a BSI Knowledge subscription, you will have the flexibility and visibility to manage the essential standards you need to work confidently and optimize your supply chain. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more.
The top 10 most adopted pharmaceutical standards
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The top 10 most adopted pharmaceutical standards

For any pharmaceutical organization to survive and prosper, they need to anticipate, prepare for, respond and adapt to incremental change and sudden disruptions. Both regulatory authorities and pharmaceutical industry itself puts great emphasis on manufacturing pharmaceutical products using practices and processes that ensure high levels of quality and safety built into every step. Pharmaceutical standards help companies involved in developing complex molecules through every stage of their new product development process and lifecycle. Our global pharmaceutical standards enhance your end-to-end manufacturing processes, providing you with the confidence that you are optimizing the time to market, whilst ensuring patient safety. The top ten most adopted standards in the pharmaceutical sector and their benefits to organizations are as follows: BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer. This international standard details the information that medical device manufacturers should supply with their products. It specifies the information to be supplied by medical device or medical device accessory manufacturers. It covers general requirements, medical device identification, requirements for packaging, requirements for marking and information on the label, and requirements for accompanying documentation. BS EN ISO 20417:2021 aims to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices. The requirements of a medical device product standard or a group standard can make use of these general requirements. Use of the standard can help medical device manufacturers to comply with the requirements of the MDR, enter new markets, develop their product information expertise, facilitate trade, manage risk and increase trust in their products. It also contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages. This goal looks for the provision of quality healthcare and also of equipment that helps healthcare providers deliver a safe, reliable, and effective service, which is what this standard supports. BS EN 13726-1:2002 Test methods for primary wound dressings. Aspects of absorbency. Most wound dressings are applied to remove excess wound fluid (exudate) from the immediate vicinity of the wound.  This part of standard BS EN 13726 specifies test methods recommended for the evaluation of some aspects of absorbency of primary wound dressings. It covers test methods which assess absorbency, fluid handling capacity, and dispersion characteristics of wound dressings. Adopting this standard means organizations can deliver a safe, reliable, and effective wound dressings, inspiring trust from their clients. BS 661210:2018 Graduated compression hosiery, anti-embolism hosiery, and graduated support hosiery. Specification. This standard specifies requirements and test methods for the compression and stiffness of graduated compression hosiery, anti-embolism hosiery, and graduated support hosiery. The test method in Annex A might also be suitable for assessing the compression of dual-layer compression kits (e.g. ulcer kits) and other tubular compression devices, e.g. arm sleeves. There are some garments for which this test method is not suitable, and where the former settings of the test instrument might not accommodate all potential designs, especially some made to measure garments. BS EN ISO 17351:2014 Packaging. Braille on packaging for medicinal products. This standard has been developed to meet requirements for Braille on packaging for medicinal products, and technical constraints and user requirements, to harmonize technical standardization and specifications. Braille will continue to be an essential means of communication for blind and visually impaired people around the world. Braille labeling is required in Europe by regulation on the outer packaging for medicinal products. This standard helps pharmaceutical manufacturers ensure they are adopting best practices to comply with regulations and deliver products which are safe to use by every consumer. BS EN 13726-2:2002 Test methods for primary wound dressings. Moisture vapour transmission rate of permeable film dressings. Moisture vapour transmission (MVTR) forms an important part of the fluid handling properties of a dressing. It influences both the hydration of the wound and that of surrounding tissues where maceration may be a problem. This part of standard BS EN 13726 specifies test methods recommended for the evaluation of wound dressings that handle wound exudate through permeability alone when in contact with water vapour and when in contact with liquid. Adopting this standard means that organizations can deliver safe, reliable, and effective wound dressings, inspiring trust from their clients. BS EN 14375:2016 Child-resistant non-reclosable packaging for pharmaceutical products. Requirements and testing. Child-resistant packaging is used to create a physical barrier between a child and a potentially hazardous product. This packaging is vital as it prevents many thousands of domestic traumas of suspected poisoning, minor spills, or ingestions that are non-fatal but nonetheless worrying. This standard specifies performance requirements and methods of testing for non-reclosable packaging that has been designated child-resistant. It is intended for type approval only and is not intended for quality assurance purposes. For medicinal packaging manufacturers, adopting this standard helps them to approve packaging types and comply with regulations. To read more on child-resistant packaging, click here. BS EN 13726-4:2003 Test methods for primary wound dressings. Conformability. When a dressing is applied in a region or movement e.g over a joint, it is important that it allows sufficient freedom of movement to avoid damage under the dressing. A dressing that is easily extended and which returns close to its original length after extension will be more comfortable for the patient to wear. An adhesive product that extends sufficiently easily with the skin helps to prevent subcutaneous shearing damage. This part of standard BS EN 13726 describes methods for measuring aspects of conformability of primary wound dressings. In other words, it is used to check the ability of a dressing to adapt to the shape and movement of the body. This test is designed to assess the extensibility and permanent set conformability of a primary wound dressing by measuring its extensibility and permanent set. DC14/30300957 (BS EN 16756). Antimicrobial wound dressings. Requirements and test methods. The effectiveness of antimicrobial agents incorporated into wound dressings is measured by their ability to kill microorganisms within a specified contact time. Consequently, accurate determination of antimicrobial activity requires complete and immediate neutralization of the antimicrobial agent. Classification of antimicrobial dressings is not presently standardized. This draft standard specifies requirements and test methods for the antimicrobial activity of antimicrobial wound dressings. It is designed for microbicidal and microbistatic dressings. Test methods specifically for microbial binding are not included in the standard. BS EN 13726-3:2003 Test methods for primary wound dressings. Waterproofness. The ability of a dressing to maintain a waterproof barrier is important to prevent the possible transmission of bodily fluids into the wound. This part of standard BS EN 13726 describes a test method for the evaluation of waterproofness of primary wound dressings when such claims are made. This test measures the ability of the outer surface of the dressing to act as a waterproof barrier under hydrostatic pressure. Adopting this standard means that organizations can effectively test their products and ensure they are fit for their purpose. BS 3221-7:1995 Medicine measures. Specification for oral syringes delivering doses up to and including 5ml. Oral syringes are used to easily dispense liquid medication to a range of patients. They ensure precise administration of medicines, enhancing patient safety. This part of standard BS 3221 specifies general design and performance requirements for the size ranges of oral syringes for containing and delivering liquid medicines in measured volumes of up to and including 5ml. Adopting this pharmaceutical standard means organizations can check the accuracy of their syringe, manage the quality of their product, and protect their clients from risk. Want to have access to all your pharmaceutical standards - all in one place? A BSI Knowledge subscription gives you instant access to the resources you need to improve every aspect of the way you work. The flexibility and visibility it provides of the best practices guidance enable you and your team to get the most from standards - from innovation to distribution. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module and keep up-to-date with any relevant changes to your pharmaceutical strategy. Request to learn more. Join the hundreds of organizations adopting pharmaceutical best practices to manufacture products, by adding the relevant bestselling pharmaceutical standards to your collection.

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