Quality management in pharmaceuticals

Article

Managing quality with standards in the pharmaceutical supply chain

Pharmaceutical companies face a daunting array of risks to their operations, from managing complex supply chains to ensuring the safety of their patients and employees. The unique combination of strict regulatory concerns and outsourced manufacturing makes managing risk in a pharmaceutical company even more challenging. Pharmaceutical supply chain challenges Pharmaceutical and medical device products are prone to supply chain disruptions that increase costs, create potential patient safety issues, and damage brand reputation. The global reach of the pharmaceutical supply chain is such that visibility remains the number one metric that quality executives including logistics managers are currently focusing on improving. Products and raw ingredients often pass through multiple international ports and customs processes before arriving at their final destinations. The ability to track shipments and ensure product quality and supplier qualification and compliance makes the difference between a high-performing organization and one that is overexposed to significant material and reputational risks. The rise of counterfeit medicinal products globally is an example of material and reputational risk entwined in one challenge. Pharmaceutical and medical device supply chains across the globe continue to be subject to alarmingly high levels of theft, product counterfeiting, and supply chain integrity concerns. Within various international markets, serialization and traceability requirements have been implemented to combat illegal retail and counterfeits, presenting its own compliance challenges. Combatting many challenges present in this global supply chain environment will come down to product quality and qualification and compliance of suppliers that an organization allies itself with. The benefits of using standards to manage quality Standards help pharmaceutical organizations focus on building sustainable, long-term risk management systems and give them the guidance needed to effectively assess and address both internal and external threats to the resilience of their operations. They enable businesses to proactively plan for and anticipate security incidents, natural disasters, human-caused interruptions, quality problems, and other disruptions that could compromise the security of their employees and customers, harm their reputation, and prevent them from serving their patients. The key standards to help pharmaceutical organizations manage quality are as follows: BS EN ISO 9001 Quality management system helps 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 EN 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 14001 Environmental management system is an end-to-end provider of environmental and sustainability services, assisting organizations with an array of issues. This standard can help businesses to assess gaps in environmental management systems and develop strategic plans for environmental systems and sustainability. Ensure quality in your pharmaceutical organization’s supply chain by adding these standards to your collection today. Discover BSI Knowledge Over 100,000 internationally recognized standards are available for simple and flexible access with a BSI Knowledge subscription. In your quality-critical industry, our subscription service puts the control in your hands, with traceability to monitor and demonstrate your business's access to standards. 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.

Quality management in pharmaceuticals

Embedding excellence into pharmaceutical processes

Managing quality with standards in the pharmaceutical supply chain

Key Quality Management Standards for Pharmaceuticals

Trending Topics in Pharmaceutical Quality Management

Health & safety in pharmaceuticals

Innovation in pharmaceuticals

Clinical laboratories in pharmaceuticals