Navigating Pharmaceutical Regulations With Reliable 3PL Partners
The pharmaceutical industry is among the most heavily regulated. Many of the industry’s regulations relate to domestic and international logistics. Pharmaceutical companies balance compliance with profitability when shipping drugs to wholesale distributors or directly to pharmacies and health care providers. Third-party logistics (3PL) companies with pharmaceutical industry expertise can help manufacturers remain profitable by satisfying regulations within an efficient shipping infrastructure. Choosing an experienced 3PL partner promotes pharmaceutical compliance and revenue growth.
Understanding Pharmaceutical Regulations
Various governing bodies regulate the pharmaceutical industry with the goal of protecting patients. Regulators seek to ensure pharmaceutical manufacturers utilize shipping practices that prevent product damage, spoilage, loss and theft. Numerous regulations promote safe freight packaging, climate control, record keeping and more.
Pharmaceutical shipping regulations come from numerous prominent organizations, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and the World Health Organization (WHO). The following are some of the most impactful regulations and guidelines for pharmaceutical shipping.
Code of Federal Regulations Title 21
Title 21 of the Code of Federal Regulations (CFR) is the set of policies that the FDA can uphold under the Drug Supply Chain Security Act (DSCSA). The DSCSA amends the Federal Food, Drug, and Cosmetic Act (FFDCA). The code requires pharmaceutical shippers to follow any product storage temperature and climate conditions that manufacturers provide on product labels or other official documents. It also covers topics relating to the cleanliness, sanitation, organization, monitoring and documentation of pharmaceutical shipping facilities, shipping assets and practices.
Good Distribution Practice (GDP)
Good Distribution Practice is a set of EMA quality standards that a product must maintain throughout the supply chain. Shipping companies are responsible for ensuring the product continues to satisfy quality standards when it reaches its destination. Complying with these guidelines requires secure, climate-sensitive storage during shipping. Shippers must also verify a product’s age and provide timely transportation to align with turnover requirements.
Health Canada’s Guidelines for Environmental Control of Drugs During Storage and Transportation
Health Canada offers guidelines to help pharmaceutical shippers comply with the Canadian Food and Drugs Act. Like Title 21, Health Canada GUI-0069 establishes standards for warehousing, storage and product transportation. It also covers standards for containers and container labeling, receiving and documentation.
WHO Guidelines on the International Packaging and Shipping of Vaccines
The WHO Department of Immunization, Vaccines and Biologicals establishes guidelines for packaging and shipping vaccines. These guidelines influence the regulations and standards that nations worldwide implement for vaccines. Packaging, temperature monitoring during shipment, storage volume, labeling and packaging, and shipping and arrival are each key components.
Challenges Meeting Regulations
Pharmaceutical companies are responsible for understanding and applying domestic and international regulations for compliant packaging and transportation. These regulatory responsibilities compound with general shipping management work and the processes of developing, marketing and selling pharmaceutical products. Failing to comply could cost the pharmaceutical company money in violation fees and lost revenue. Managing so many responsibilities can spread a manufacturer’s resources thin.
The Role of 3PL Partners in Pharmaceutical Shipping Compliance
Pharmaceutical manufacturers can navigate the complex shipping regulation landscape by partnering with a company that specializes in shipping. A 3PL company can manage the planning and execution of shipping strategies for its clients. These companies have robust internal shipping resources, including personnel, trucks, warehousing facilities, material handling equipment and packaging tools. They may also offer capabilities like freight brokerage to connect clients with a cost-effective outsourced shipping solution.
Crown LSP Group is a 3PL company with resources and expertise relevant to the pharmaceutical industry. As an experienced pharmaceutical industry 3PL partner, we help manufacturers comply with all relevant regulations while continuing to deliver on efficiency goals and meet delivery timelines. Our combination of logistics and pharmaceutical industry experience positions us to apply pragmatic solutions to our clients’ most prominent logistics challenges.
Benefits of Partnering With Reliable 3PL Providers
Partnering with an experienced 3PL company like Crown LSP Group creates numerous benefits for pharmaceutical manufacturers.
Logistics Dedication
The primary advantage comes from the 3PL partner’s time and resources. Where pharmaceuticals generate value from drug production, shipping is a 3PL company’s primary focus. They have the time, money, transportation and warehousing tools, and personnel to perfect the shipping process, even when navigating the complexities of pharmaceutical compliance.
Shipment Timeline Management
Our broad range of 3PL services and assets promotes timely shipment. We optimize our shipping routes and maintain a robust shipping fleet to manage tight delivery deadlines.
Pharmaceutical Product Preservation
We maintain specialized shipping resources like temperature- and climate-controlled warehouses and freight. Our pharmaceutical-focused logistic capabilities simplify product security, whether shipping a full truckload of sensitive medicinal products or adding them as a partial truckload shipment.
Revenue Optimization
With our help, pharmaceutical manufacturers enact efficient, compliant shipping practices that maximize revenue from sales. Products arrive on time and in proper condition, maintaining our partners’ positive relationships with their customers while avoiding fees for regulatory violations or the cost of shrinkage.
Pharmaceutical Regualtion Compliance
Our 3PL expertise coincides with pharmaceutical industry awareness. We maintain specialized equipment and provide training to build our services around the regulations dictating pharmaceutical shipping procedures. From storing products at the proper temperature to recognizing packing defects and documenting critical steps, we mitigate compliance risks for pharmaceutical manufacturers.
Choosing the Right 3PL Partner
Choosing a 3PL partner is a significant decision that will impact your revenue and risk potential. There are numerous options to choose from, and some will align with your business’s needs better than others — both now and in the future that you envision for your company. Such alignment is especially crucial in the highly regulated pharmaceutical industry.
Research your potential partners and ask them questions to determine if they offer the following qualities:
- Broad services capabilities
- Experience with pharmaceutical products
- Connections with distributors, third-party shippers and other stakeholders
- Proximity to your manufacturing facilities to distribution partners
- Cost-effective shipping services that add value
- A positive reputation with pharmaceutical companies and other customers
- Conscientious security equipment and policies
- Shipment monitoring technology
Compliant Logistics for the Pharmaceutical Industry
Shippers must secure pharmaceutical products to maintain their intended effects. Doing so protects patients and ensures compliance with the regulations that govern the pharmaceutical industry. Third-party logistics providers have the expertise and resources to transport pharmaceutical products safely and efficiently.
Crown LSP Group is a leading logistics partner for businesses in the pharmaceutical industry. We have a long history of providing valuable logistics services to pharmaceutical companies in North Carolina, South Carolina, Virginia and Georgia. Our qualifications and customizable service options position us among the best 3PL partner options for your industry.
Contact Crown LSP Group for Pharmaceutical Logistics
We are ready to maximize your revenue by facilitating efficient, compliant shipping. Please request a quote online to begin a discussion about your pharmaceutical shipping needs and our robust solutions.
