What measures has your fulfillment center taken in Quality Assurance and Regulatory Compliance?
Think about the logistics behind your healthcare products. Whether you sell supplements, durable medical equipment, surgical devices, over-the-counter remedies or any other product related to health and wellness, are you confident in the safety of your goods once they leave the manufacturing plant?
Gone are the days when you could pick a fulfillment partner solely on how cheap or how fast they can deliver an order. Today’s healthcare company must also evaluate their supply chain to ensure quality and compliance in a growing regulatory environment.
What does your logistics provider have in place to address quality assurance and regulatory compliance? Do you know your healthcare supply chain?
Quality assurance refers to the methods your fulfillment center has in place of ensuring quality, such as product safety and order accuracy. These methods are typically defined in a Quality Management System (QMS) that complies with the high standards healthcare companies require. Your fulfillment center should have a Quality Management System that addresses the specific needs of healthcare products and includes;
- Standard Operating Procedures (SOPs) documentation and regular audits of those standards – not just order picking and packaging, but processes for inbound quality checks, facility cleaning, personnel hygiene, etc…
- A Corrective and Preventative Action (CAPA) process in place to formally address and resolve identified areas of non-conformance
- Developed metrics to assist in the management and continuous improvement of quality standards
- Professionals in the organization solely dedicated to quality and independent from daily fulfillment operations
In conjunction with quality controls, your fulfillment operations must also manage being in compliance with all applicable regulatory standards. In fact, it would be unlikely that a company could adhere to the regulatory standards guiding healthcare supply chains without a robust dedication to quality assurance. The US Food and Drug Administration’s (FDA) rules are established in Title 21 of the CFR (Code of Federal Regulations). Within 21 CFR are the various subchapters that regulate the food and drug supply chain, from manufacturing to storage to delivery of product to the end-user. Regulatory compliance under 21 CFR does introduces several levels of scrutiny that need to be specifically addressed by your logistics partner.
21 CFR – the FDA
Subchapter B – Parts 100 – 191 Food for Human Consumption
Part 110 – Current Good Manufacturing practice in manufacturing, packaging or holding human food
Part 111 – Current Good Manufacturing practice in manufacturing, packaging, labeling or holding operations for dietary supplements
Subchapter C – Parts 200 – 299 Drugs
Part 210 – Current Good Manufacturing practice in manufacturing, processing, packaging or holding of drugs
Part 211 – Current Good Manufacturing practice in finished pharmaceuticals
Subchapter H – Parts 800 – 898 Medical Devices
Part 821 – Medical device tracking requirements
The above represents a sampling of sections of 21 CFR that are relevant to the supply chain.
Current Good Manufacturing Practices (cGMP) Compliance
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA to ensure the safety of healthcare products. cGMP includes establishing strong quality management systems with well conceived and defined processes and procedures. cGMP requirements are flexible in order to allow each company to decide individually how to best implement the necessary controls specific to their operations.
Food Safety Modernization Act (FSMA) Readiness
Companies that store product off-site with a third-party warehouse should ensure the safety of their products and compliance with the FSMA. Most supplements and other ingestible healthcare products are considered ‘food’ for the purpose of the Act. Therefore, companies providing these products need to qualify their fulfillment centers and review procedures, including environmental controls, pest management and sanitation.
Hazard Analysis and Critical Control Points (HACCP) Plan
A HACCP plan is important to creating a safe and secure healthcare supply chain and enhancing FSMA readiness. At its core, the purpose of the HACCP plan is to identify hazards to food safety and create controls and procedures to prevent or minimize those hazards.
As healthcare products travel along the supply chain from manufacturer, through the warehouse to the end-user, the ability to track and trace product must be maintained. A key component of this is having a fulfillment center that is capable of tracking data points such as manufacturing lots or medical device serial numbers. In addition, these data points must be reliable and easily accessible. Regular mock recalls are a good test to ensure proper traceability.
Third party validation of the internal procedures and quality management systems of a healthcare supply chain are essential to maintain the high-level of standards put on healthcare product providers. There are a variety of organizations that will provide audits of the fulfillment center to desired levels and/or specifications.
Companies selling healthcare products need to be completely aware of the safety and integrity of their products, not just during production, but also as those products move through the entire supply chain. Don’t just concern yourself with the quality assurance and regulatory compliance of your manufacturer. Know how your fulfillment center addresses these as well. Know your healthcare supply chain!