Pharmaceutical Supply Chain Software and Regulatory Compliance

Every business is run through regulations that have been put in place. The need for change arises, creating a shift in the normal dynamics of running a business. For the pharmaceutical industry, procedural inadequacies in the drug manufacturing process prompted the need for evaluation. Issues such as drug recalls raised concerns in the aspect of quality of the products manufactured by pharmaceutical companies.

The United States Food and Drug Administration (FDA) Regulations

The FDA is responsible for regulating drug manufacturing and checking the product quality in the United States. In 2002, they started a campaign to modernize the procedure of drug regulations so as to ensure better product quality. They encouraged companies to use new technology throughout their production process and restructure their supply chain. Managing the supply chain was the major challenge for pharmaceutical companies. This meant that they needed to track their products at the point of sale.

Based on the Drug Supply Chain Security Act (DSCSA) and the Drug Quality and Security Act (DQSA) of 2013, there is FDA enforcement on supply chain integrity. The serialization process that tracks drugs through the supply chain and the visibility during the process is mandatory for pharmaceutical companies. This requires collaboration and trust between the partners in the entire process. This strategy has been successful in maintaining security and product quality and in disrupting the distribution of counterfeit drugs.

Supply Chain Software

This is the software that helps keep track of their products in the supply chain. Because there are many people involved, and the distribution could be on a global scale, there is a need for visibility. This is from the moment you acquire the raw materials needed to develop a drug, to the time a customer buys it. With the number of people working in the supply chain, companies may not be able to evaluate the integrity of their products in the supply chain relying on word of mouth.

Supply chain software such as rfXcel maintains the integrity and security of your supply chain as well as giving you real-time updates. A pharmaceutical company produces drugs that save lives and when counterfeits mess up this integrity people lose lives. Supply chain software will also help you better understand the dynamics of the market because you have eyes on every stage of the supply chain.

This means that you know who is responsible for what and how much you put out there, coupled with the demand that is out there. It all starts when you fill this contact form. It is easier to run your pharmaceutical business when you know that your operations are handled by cutting edge technology. This gives you the confidence you need to manufacture drugs that keep saving lives, and at the same times enables you to comply with drug laws and regulations.

Technology has revolutionized the pharmaceutical industry and allowed governments to reduce violations in the drug production process. The supply chain is the heart of that process, and that is why major emphasis is placed on it. Your product is your business and maintaining its quality is maintaining the prosperity of your business.

Contact Information:

Theresa S. Olson

2570 Wildwood Street

Akron, OH 44305

TheresaSOlson@dayrep.com

Phone: 330-732-1911

Media Contact
Company Name: DayRep
Contact Person: Theresa S. Olson
Email: Send Email
Phone: 330-732-1911
Country: United States
Website: http://www.pharmtech.com/fda-pushes-dscsa-serialization-enforcement-deadline-2018