In regulated industries, a third-party logistics (3PL) provider that understands the common hurdles and how to navigate the changing rules and regulations ensures the continuity of your supply chain. For this reason, pharmaceutical manufacturers need to be selective about which 3PL partners they work with. 

3PLs with expertise in pharmaceutical supply chains align their operations with Current Good Manufacturing Practice (cGMP) regulations to ensure compliance and mitigate potential risks related to product contamination, adulteration, or compromised quality. LogiCare3PL’s operations are cGMP and DSCSA compliant and offer licensing and regulatory services with an in-house quality and regulatory expert. 

What do cGMP and DSCSA really mean? What other trade regulations do pharmaceutical manufacturers need to be aware of? We answer these questions, and offer our guidance, below:

 

Why cGMP is important in 3PL

cGMP is a set of regulations and guidelines established by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), to ensure the quality, safety, and efficacy of pharmaceutical and healthcare products. While cGMP is primarily associated with manufacturing, it can also have implications for Third Party Logistics (3PL) providers in the pharmaceutical and healthcare industry.

 

Compliance and regulatory requirements 

Many pharmaceutical and healthcare products are subject to strict regulatory requirements — adherence to cGMP is mandatory. Companies within the supply chain, including 3PL providers, must comply with these regulations to ensure that products are handled, stored, and transported in a manner that maintains their quality and integrity.

 

Product quality and integrity 

cGMP emphasizes maintaining the quality and integrity of pharmaceutical products throughout the supply chain. 3PL providers play a crucial role in warehousing, handling, and transporting these products. Adhering to cGMP ensures that the conditions under which products are stored and transported meet the required standards to prevent degradation or contamination.

 

Risk mitigation 

Strict adherence to cGMP standards helps mitigate the risk of product recalls, quality issues, or regulatory non-compliance. By incorporating cGMP principles into their operations, 3PL providers contribute to a more robust and reliable supply chain, reducing the likelihood of disruptions that could impact the availability of critical healthcare products.

 

Customer trust and reputation 

Pharmaceutical companies rely on 3PL providers to maintain the highest standards in handling and distributing their products. Adhering to cGMP not only ensures compliance, but also helps to build and maintain trust between 3PL providers, pharmaceutical companies, and regulatory authorities. A strong reputation for compliance and reliability is a competitive advantage in the industry.

 

Documentation and traceability 

cGMP requires thorough documentation and traceability throughout the manufacturing and distribution processes. 3PL providers need to implement systems that allow for accurate record-keeping and traceability to comply with these requirements.

 

Why DSCSA compliance is crucial in 3PL

The Drug Supply Chain Security Act (DSCSA) is a U.S. federal law enacted to enhance the security of the pharmaceutical supply chain. DSCSA compliance is particularly important for 3PL providers operating in the pharmaceutical industry.

 

Patient safety 

The primary goal of the DSCSA is to safeguard public health by preventing the distribution and dispensing of counterfeit, adulterated, or otherwise unsafe drugs. 3PL providers play a crucial role in the pharmaceutical supply chain — compliance with DSCSA helps to ensure the drugs they handle are legitimate, safe, and have not been compromised.

 

Traceability 

DSCSA establishes requirements for the traceability of prescription drugs throughout the supply chain. 3PL providers must be able to trace and track the movement of pharmaceutical products, including their receipt, storage, and distribution. This traceability is essential for quickly identifying and isolating any suspect or illegitimate products in the event of a recall or security issue.

 

Serialization and product identifier requirements 

DSCSA mandates the use of unique product identifiers, including serial numbers, on certain prescription drug packages. 3PL providers must be capable of handling and verifying these unique identifiers to ensure the authenticity of the products in their custody. This helps prevent the introduction of counterfeit drugs into the supply chain.

 

Communication and collaboration 

DSCSA promotes enhanced communication and collaboration among supply chain stakeholders. 3PL providers need to interact with manufacturers, wholesale distributors, and dispensers to exchange transaction information (TI) and transaction statements (TS) for each product. Compliance with DSCSA facilitates smooth communication and information exchange across the supply chain.

 

Regulatory compliance 

Failure to comply with DSCSA requirements can result in serious consequences, including fines and legal actions. 3PL providers are subject to regulatory oversight and adherence to DSCSA is necessary to avoid legal penalties and maintain a good standing within the pharmaceutical supply chain.

 

Industry reputation 

Pharmaceutical manufacturers and other stakeholders expect their 3PL partners to adhere to regulatory standards. DSCSA compliance enhances the reputation of 3PL providers in the pharmaceutical industry, demonstrating their commitment to safety, security, and regulatory compliance. This, in turn, can lead to stronger and more trust-based relationships with clients and other partners in the supply chain.

 

​​In the dynamic landscape of pharmaceutical distribution, maintaining impeccable quality standards is paramount. Every step of the supply chain, from manufacturing to delivery, must adhere to rigorous protocols to ensure the safety and efficacy of medical products.

 

LogiCare3PL takes pride in providing both high quality service and a high level of quality control across its distribution network. With cGMP facilities and compliance with DSCSA, LogiCare3PL is a trusted partner for pharmaceutical manufacturers who demand quality control excellence. Contact us today to learn more about how we can support your pharmaceutical distribution needs.