Establishing a Successful Supply Chain for High Value Products
Two of the greatest risks in high value BioPharma supply chains are the product adulteration during transport and non-compliance with regulations, guidelines and standards. After that, an important concern of manufacturers and distributors is cost containment in an increasingly globalized and complex supply chain.
At every point in the chain, precautions should be taken to minimize the effect of external conditions on the quality and stability of the product. It is mandatory that records provide reliable up-to-date evidence of compliance, in case of audits and investigations from health authorities and other stakeholders. In order to do that, it is advisable that the logistics provider performs a risk analysis, which focuses heavily on the following areas:
- Evaluation, audit and qualification of the involved suppliers
- Guarantee security and quality by risk assessment + key process description
- Staff training and correct infrastructure for risk mitigation
Importance of performing supplier approvals
Supplier qualification is a key element of any pharmaceutical quality assurance system. In pharma logistics, according to the cGDP, the management of outsourced activities must rely on the qualification of service and materials providers. The client is responsible to assess the competence of the service partner. Beyond the regulatory aspect, the additional benefit generated from the qualification is the control of risks.
Key steps to identifying and performing supplier qualification
An effective supplier qualification program should include, at a minimum, the following critical elements:
- Initial Screening Process: The initial screening process should confirm that the supplier can meet the specifications for the component or service to be provided. It is typically performed using a screening questionnaire, requesting that the potential supplier provide appropriate supporting documentation. Supplier risk must be assessed in advance according to the criteria defined in the corresponding SOP so that scope and frequency of re-qualification activities may be assigned in order to ensure continued compliance with both customer and regulatory requirements.
- Qualification On-site Audit: The next step in the qualification process will typically be an on-site audit of the supplier’s facilities.
- Management Evaluation and Approval Process: Upon the completion of the audit, the client determines the status of the supplier based on the findings. If deficiencies are identified during the audit, it must be clarified whether they prevent the supplier from being approved or if the supplier is able to take appropriate corrective actions that will enable their qualification. The supplier might also be considered approved, conditionally approved, or unapproved. The client should have defined processes for changing the qualification status of any supplier, and for actions required if a critical supplier is disqualified.
- On-going Performance Monitoring: Once the supplier is qualified and the client begins using it on a regular basis, its overall performance should be periodically compiled and reviewed by the management with the supplier (e.g. Customer Complaints, Environmental Excursions, On-time Delivery Results, etc.). Negative or abnormal trends should be addressed with appropriate corrective action plans and the effectiveness of corrective actions should be measured.
A robust supplier qualification program is a critical element in a compliant quality system for any pharmaceutical company. Having such a program assists a firm in minimizing risks, preventing significant interruption of supply, and improving communication between the company and its suppliers.
Risk assessment to identify areas requiring risk mitigation
In transporting products requiring low-temperature storage, the type of shipping/thermal system will be determined by evaluating the load size, the nature of the product, the risk presented by high and low temperatures and fluctuations, and the time of exposure to adverse conditions.
Work with approved suppliers to outline processes
Biotech products should preferably be transported under strict controlled conditions. This control can only be assured by using suitable materials, monitoring devices and vehicles, undergoing a qualification process by their suppliers. For the primary protection of the products, temperature-stabilizing materials (i.e. passive cool boxes) should be chosen with care and evaluated prior to usage. Refrigerated vehicles should be fitted with continuous recording devices in order to monitor the temperature. Moreover, a number of data loggers is carefully placed in the load to ensure acceptable temperatures. The loggers have to be purchased by a supplier assuring their traceable calibration and reliability.
Run “PQ” test shipments
The supply chain has many links; each one requires thorough records and many stakeholders can contribute to them in the chain. The distribution path can include different types of transportation and several climatic zones, and each new mode of transport and location will come with its own exposure hazards. Performing PQ test shipments or controlled real-world testing using actual product, or a representative surrogate, with approved protocols is important to mitigate risk in the distribution process.
Documentation is key to compliance with regulations. Therefore, it is important, when setting up a cold chain management system that complies with regulations, to create or obtain detailed records of data, e.g. shipping and storage durations at each point in the journey, and contingency procedures for delays, out-of-specification conditions or other unexpected events. Suitable validation protocols will be defined, by taking into account the type of product and its characteristics, the packaging requirements, the route of transportation and the possible failures (if necessary, a validation may be performed in “worst conditions” by using a “representative dummy payload”).
Regulatory training requirements
The GDP Guidelines* state that “All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks.” This means that, before a new employee can perform any activities related to medicinal products, training has to be performed and documented. Initial and continuing training is required. Even if some employees have been performing a certain task for years, training records should state that a regular ongoing instruction was performed. A training program and an SOP which defines how it is managed is a key requirement. In order to have a comprehensive training program for all employees, a monitoring system is needed to identify when new or follow up training is required. Records should be kept on file and the effectiveness of training should be periodically assessed and documented.
*Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), Paragraph 2.4 ”Training”
Having engaged, trained, and trusted employees can contribute to operations running smoothly. Losing talented and trained employees is a risk that a company should minimize, as it could cost the organization knowledge, time, and effective processes. Losing A-players could be very expensive for the company. The real cost of replacing an employee is somewhere between 90 and 200 percent of their annual salary. Keeping an experienced and skilled team is crucial for a sustainable business growth. Providing an environment of training and trust can greatly aid in reducing turnover.
Lane/Client/Product specific procedures and training
Managing oversight of the varied supply chains for many different customers can be a difficult task, especially if the management of critical elements of the supply chain is largely out of the client’s direct control and rests in the hands of entities in a different city, region or perhaps even a different country. Necessarily, the stakeholders must rely on routine project meetings or teleconferences for updates to learn the status and timing of the operations. Close collaboration with the client provides an extra level of review that could prevent potentially catastrophic failures. A thoughtful and proactive review of the supply chain may mitigate a multitude of potential risks. Therefore, it is very important to define some pillars that may be specific to a client/product/lane:
- Documentation: As the transportation routes, qualification is an important issue. It may be necessary to define procedures and protocols in order to keep under control all the variables involved in the process. Complex supply chains may require product management by multiple firms and include handoffs and in-transit interaction necessitating collaboration between teams. Providing clear procedural guidance will mitigate risks of mishandling and allow for documentation of key process steps and important data.
- Storage Facilities: Some customers may require dedicated storage areas, allowing the segregation of their products from the rest of the stock and the assurance of strict storage conditions. For example, the implementation of a customer-dedicated ultra-deep freezing farm is a challenge involving multiple activities. Client/product specific needs dictate comprehensive risk analysis during the onboarding to ensure storage activities can be appropriately carried out to mitigate risk of product loss or degradation.
- Packaging Solutions and Transportation Services: Based on product characteristics and the needs of the customer, it is very important to define procedures for the product pack-out for shipment. The definition of the kind of packaging (e.g. passive or active cool containers) is often confirmed with a validation study.
The availability of the right infrastructure, with an effective monitoring system and highly specialized personnel, makes so, that the company is ready to react to any problem with appropriate corrective and preventive actions.
The goal of any supply chain is to transport products from the manufacturer to the consumer. The success of a supply chain depends on and is measured by its ability to deliver products that can serve their ultimate purpose with the end user in mind, unadulterated and with its efficacy fully intact. In the context of a successful BioPharma supply chain, the stakeholders have to act as partners in quality. With globalization and emerging markets, basing the regulatory compliance on a robust risk mitigation program will ensure that the fundamental requirements of a safe supply chain for drugs and biotechnology are satisfied.
Now that you’ve learned how to establish a High Value BioPharma Supply Chain, learn how to Maximize Batch Yields in Aseptic Manufacturing.
Airpharm Logistics Care and Singota Solutions partner together to help clients with customizable solutions for international storage and logistics. Both companies hold a standard for agile, reliable, and quality service, which helped solidify the relationship.
Airpharm is a 3PL company, specialized in Life Science Products. Founded in 2010 in Pratteln, Switzerland, the company offers customer tailored solutions with a customs bonded warehouse with GMP/GDP approved temperature controlled storage areas (ranging from -80°C up to +20°C), and full expertise on customs clearance service as well as temperature controlled transportation by air, sea and truck all over the world. For more information, please visit www.airpharm.ch.
Singota Solutions is a contract development and manufacturing organization focused on moving products through the development pipeline faster—with agility, accountability, and transparency. Founded in 2006, the company is a woman-owned business operating in Bloomington, Indiana. Singota’s gloveless, robotic aseptic filling service is ideally suited for the production of clinical and niche commercial injectable products in vial, syringe, and cartridges formats. Singota also provides customized solutions for formulation development, supply chain & materials management, analytical testing, and labeling & kitting services. For more information, please visit www.singota.com.