by Christophe Couturier and Rick Campins
Life science laboratory workflows, products, and services are complex and can be complex to manage due to stringent processes and requirements. In a Deloitte survey of risk and compliance management professionals in India, 61% of respondents felt that there was a lack of efficient internal controls and compliance within the life sciences industry.1 This can result in an erosion of customer, regulator, and shareholder confidence.
The biopharma industry must respond and adapt to changing market conditions and uncertainties. In a highly regulated industry like biopharma, effective risk and compliance management is essential. Pharma companies can prepare for changes by identifying, managing and mitigating risks, thereby improving flexibility and agility.
The ability to consistently meet applicable requirements and withstand regulatory scrutiny is dependent upon both effective quality management systems (QMS) and subject matter expertise. Avantor has a rigorous QMS that meets the highest standards in quality and regulatory compliance, including third-party International Organisation Standardization (ISO) certification for its products and services. This offers third-party confirmation that a business’s goods, services and operations adhere to quality and regulatory standards and legal obligations.
Companies that offer life science products and services are expected to have proactive risk identification and robust policies and procedures that align with the directives of the regulatory authorities in their target markets. Compliance requirements for all workflows include:
- Validation of analytical methods and procedures to establish the accuracy, reliability, and reproducibility of the method.
- Calibration and qualification of equipment to provide evidence that the equipment and computer systems are suitable for the intended use.
- Procedures for instrument maintenance for regular preventive upkeep of hardware as well as backup mechanisms for the software to detect and prevent errors before they can negatively impact analytical data.
- Control and monitoring of environmental conditions like temperature and humidity to ensure that they do not adversely affect the performance of the equipment and material.
How can providers of research, development and production products and services enable customer innovation, effectiveness, and efficiency? Consider these five strategies:
1. Global Infrastructure
To facilitate supply chain efficiency and strengthen ties with key players in the biopharma ecosystem, it is imperative that biopharma providers establish a robust global geographical footprint and
infrastructure. This entails strategically positioning facilities worldwide, and these global manufacturing hubs need to meet the stringent cGMP standards and gain approval from regulatory bodies, such as the Food and Drug Administration (FDA) or comparable foreign regulatory authorities. By strategically establishing facilities across different regions, biopharma providers can optimise their supply chains, ensuring closer proximity to their valued customers. Additionally, the presence of innovation centres within the biopharma ecosystem is instrumental, as they serve as hubs for collaboration and customisation, both of which are indispensable factors in serving highly regulated, specification-driven applications.
Ideally, the optimal manufacturing capabilities should include: (i) an ability to quickly change specifications depending on customer needs; (ii) numerous flexible unit operations, enabling production scalability, from laboratory pre-clinical development to large-volume commercialisation; (iii) proprietary purification technologies designed to ensure lot-to-lot consistency through ultra-low impurity levels; (iv) rigorous analytical quality control testing; and (v) robust regulatory and quality control procedures. We consistently deliver these capabilities across all our manufacturing hubs at Avantor.
Avantor has over 200 facilities located throughout the globe that include manufacturing, distribution, service, research, technology, and sales centres. These facilities in North America, Europe, and the AMEA region enable supply chain efficiency and increased proximity to customers. This global footprint also allows Avantor to enhance the security of supply and provide real-time flexibility to its customers.
Avantor’s new Singapore Manufacturing and Distribution Hub (SMDH) consists of ISO 9001-certified laboratory and repackaging facilities and follows cGMP standards for excipients. SMDH provides services including quality control and inventory management, and features cGMP manufacturing suites and testing labs for process, raw materials, and excipients. The hub will allow shorter lead times, enhance supply chain security, and increase capacity in the region.
2. Incorporating Quality Management in Laboratory Environment
Providing a certified and cGMP facility along with efficient capabilities for regulated and non-regulated products and services is essential in enhancing laboratory standards. Along with following and maintaining rigorous quality control, aspects such as change control, management control and corrective and preventive action (CAPA) are an integral part of the quality system. Besides having a formal QMS that backs consistent procedures, it is essential to have an assessment system in place that involves comparing laboratory performance to internal standards for quality or external data sets, such as industry benchmarks. In case of any error or non-conformance, the QMS can identify it, discover the root cause, and prevent its reoccurrence.
Training, accountability, and engagement of laboratory staff members are vital aspects of the QMS. Laboratories also need to monitor all the equipment to ensure their safe operation and follow standard safety measures such as physical security, containment procedures (in case of hazards) and worker safety. Avantor’s facilities are equipped with a range of high-quality absorbents, labelling systems, safety products, and workwear, which are integral to maintaining safety in the quality and operational areas.
All the data from the laboratory, including standard operating procedure (SOP) documents, needs to be accurate, secure, confidential, and accessible to individuals with the appropriate privileges. The laboratory also needs to understand its customers and use customer feedback for further improvement.
Quality is an essential element of every process, program, product, and solution, as it tracks and shares its performance with the customers, allowing them to benefit from enhanced regulatory compliance and minimised risk.
3. Using High-Quality Chemicals, Consumables, and Equipment
High-quality chemicals, consumables, equipment, and instrumentation should be used for testing or manufacturing purposes. Characteristics to be considered when selecting laboratory consumables include durability, efficiency, manufacturer’s data collection method, and storage facility.
Working with a reliable supplier can provide businesses with many benefits, including access to chemicals and reagents that meet stringent industry and global regulatory standards, customisation, streamlined procurement process and overall improved efficiency. Validating the accuracy of the experiment is always imperative. Avantor focuses on an array of testing around novel life-saving drugs, vaccines, and diseases. The laboratory research equipment and consumables are designed to reduce process variability, increase reproducibility of results, and enhance testing efficiency. The procurement process is also simplified with one-stop sourcing and responsive fulfilment.
4. Building Agile Solutions
Production process efficiency is a critical factor in successfully increasing innovation within a demanding scientific landscape that is constantly evolving. The implementation of effective inventory software is essential for companies to have a complete idea of their inventory and associated material wastage. With cyber-attacks on the rise, deploying technologies that segregate manufacturing functions can better protect them from vulnerabilities in networked operational systems. Improving coordination and communication among the various stakeholders also remains key to an agile system.2
Avantor builds agile solutions using tools such as Value Stream Mapping (VSM; an element of the Avantor Business System model) that captures a precise view of the user’s current situation to enable process redesign and deliver superior results. VSM tools can also support quality teams by identifying opportunities for improvements in QC processes and product availability. In one such case, the teams were successful in creating a test method-based process flow that reduced sample approval lead time by greater than 95%.
5. Embedding Sustainability Into the Lab Ecosystem
In addition to ensuring responsible production processes, innovative sustainability practices such as inventory optimisation solutions can be implemented within the laboratory ecosystem to prevent wasteful purchasing processes in laboratories. Coordinating with suppliers who provide validated sustainability credentials of equipment, instruments, and consumables, covering a range of real experimental operating conditions or configurations is also important.
Avantor has an energy and emissions reduction strategy that invests in efficiency and conservation projects, as well as alternative energy sources. Through its Environmentally Preferable Products (EPP) program, Avantor provides greater transparency to its customers, helping them make more informed and sustainable purchasing decisions.
Today, the purview of quality goes beyond the consistent yield of superior products. Implementing customisable, flexible solutions that manage and optimise end-to-end laboratory operations will secure lab staff by providing them with a safe working environment and bolster customer connections.
Proactive risk management strategies across the supply chain along with stringent quality assurance and quality control procedures guarantee that the finished goods comply with all applicable regulations and meet client expectations. Partnering with the right supplier can provide a range and scale of quality services that are customised to your business needs, leading to streamlined workflows that ensure quality while fostering innovation. [APBN]
About the Authors
Christophe Couturier, Executive Vice President, AMEA at Avantor, has extensive strategic leadership experience in the life sciences industry. Mr Couturier leads sales, marketing, and customer service in AMEA, as well as the Avantor Business System and its associated LEAN processes globally. He earned a Master of Science in management from ESSEC Business School in France.
Rick Campins is Avantor’s SVP of Global Quality and Regulatory. Mr Campins has over 30 years of experience in highly regulated industries, to includes Boston Scientific, Danaher, and 3M. Mr. Campins obtained Masters degrees in Business Administration and Regulatory Affairs and Services from the United States.