The COVID crisis has done many things, but in particular, it has showcased the vastness and complexity of modern supply chain management. The branches of the modern supply chain extend far and wide, from manufacturing to distribution to allocation of a vaccine. Clearly, internal and external supply chain management is critical to maintain FDA compliance. So, what lessons can be learned from the complexity of the distribution of the COVID vaccine? Here are three important aspects highlighted by the pandemic:
There are at least ten ingredients in each of the first waves of COVID vaccines released to the market. In the eyes of the FDA, it is not simply enough to ensure that the vaccine is safe, pure, and effective. Vaccine manufacturers are required to ensure their raw materials are, too. This can only happen through comprehensive vendor management.
Vendor management entails more than just audits and questionnaires. Outsourced services, such as testing, engineering, and sterilizing, for example, must be vetted through careful risk-based assessments.
Vendors must also have the right experience, a robust quality system, and sufficient resources to meet production needs. Documenting the vendor management system is a must, and this includes not just SOPs, but other forms such as confidentiality agreements, quality agreements, and audits.
InstantGMP PRO provides a seamless way to integrate and manage all the requirements for a vendor management program in one place. By using the Vendor Management feature of this All-In-One Manufacturing and Quality Software, one can organize approved vendors, issue tasks to personnel, and even send ready-made forms to vendors to complete. Documentation is safely housed electronically and is 21 CFR compliant.
MATERIAL CONTROL & TRACEABILITY
The volume of COVID vaccine necessary is staggering. Vaccine production from one manufacturer will equal more than 50 million doses this year and 1.3 billion doses next year. It is easy to understand how working under this kind of pressure can increase the risk of non-compliance.
Knowing the status and location of in-house materials is an important pillar of supply chain management. For any given material, component, in-process product, or finished product the manufacturer must be able to provide a detailed history of its life cycle.
This history includes traceability of raw materials to finished products, batches to manufacturing lines, and results to specifications. In the event of a discrepancy, the FDA requires risk to be assessed. Prompt traceability of materials in house improves the efficiency production processes. InstantGMP PRO automatically provides this traceability by linking relevant records, making it easy to assess release status and prevent improper release.
Controlling materials and products in house is also crucial to manufacture the right product at the right time and right specification. It takes a massive amount of documentation and personnel to prove compliance. Paper-based systems leave room for errors and regulatory citation. Eliminate paper-based systems and the mishmash of multiple electronic systems with InstantGMP PRO. Because the modules are linked together in one cloud-based location, less time is wasted, and risk is reduced.
Getting vaccines to market has been a critical key to ending the COVID pandemic. Fortunately, the worldwide supply chain in place for the COVID vaccine has been successful. This is in part due to a well-managed, flexible supply chain for internal and external vendors.
Improperly managed transportation, warehousing, distribution, and delivery systems within the supply chain could lead to unnecessary danger for patients if proper control is not maintained.
In the unplanned event of a product recall, being able to locate every affected batch is vital to ensuring patient safety as well as FDA compliance. InstantGMP PRO solves this difficulty by automatically linking inventory records with distribution records for individual batches.
It can be overwhelming when faced with the task of implementing an FDA compliant supply chain management system. Streamline the supply chain management system into a flexible, easy to use system by using InstantGMP PRO or InstantQMS. Let InstantGMP PRO solve your supply chain management problems so you can focus on innovation.
If you’re interested in learning more about the InstantGMP Supply Chain Management Solution, you can schedule a live demo with one of our expert team members.