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What You Need To Know About Achieving Compliance with FDA Laws and Regulations

In the Pharmaceutical industry, the operational processes and regulations play a pivotal role in ensuring that the organization is in compliant with the FDA. This is necessary for both pharma and biotech companies as they need to ensure they follow the guidelines set by the FDA in order to manufactured products that do not pose a threat to public health and safety. To be able to gain a deeper understanding of the importance of FDA compliance and the policies laid out by them, you need learn more about what the FDA does, how it operates and the areas of its jurisdiction.

FDA laws and regulations

What does the FDA do?

The Food and Drug Administration is a US federal agency responsible for ensuring the safety, security and efficacy of consumable goods that include food products, tobacco products, pharmaceutical drugs, dietary supplements, vaccinations, medical equipment, cosmetics, etc. Since the FDA is responsible for the protection of public health and safety, they have the authority to establish and monitor rules and laws governing the consumer goods industry as well as penalize any organization that doesn’t comply with their regulations.

FDA Compliance Policy Guides

The compliance policy set by the FDA requires the companies to adhere to a set of validation programs designed to allow easy assessment by FDA personnel while evaluating the quality of the food products and drugs produced. Following are the guidelines that have been established by the FDA:

  • Alerting authorities in case of FDA law violations and/or potential health hazards

As per the FDA’s validation process, FDA personnel of any grade or rank, have the responsibility to notify their supervisor whenever they identify any kind of violation of FDA laws and regulations, or they come across something that may be hazardous to public health. Their supervisors and directors are then required to take the necessary action during the validation program.

  • Taking action against products made from inter-state shipments

The FDA has full jurisdiction over products manufactured from interstate materials, even if the finished product isn’t involved in interstate shipment itself. In such cases, depending on the quantity of interstate ingredients present in the product, authorities can take decisive action against the organization after assessing the severity of the violation.

  • Mandatory registration of food producing facilities

Both domestic and international facilities, owned by US based individuals that are involved in production, processing and/or storage of human and animal food are required to attain official FDA registration in order to run operations in USA.

  • Strict action against products or materials carrying disease hazards

The FDA also monitors the movement of non-registered products or animals that may contain elements that are contaminated, spread dangerous infections or pose a risk to the public wellbeing. Therefore, during the validation process, all FDA personnel are required to keep an out for such substances and report them upon identification.

  • Regulation of products moving to and from Foreign Trade Zones

As per the FDA policy, Foreign Trade Zones are a part of USA. Thus, movement of products in and out of these zones are considered to be a part of interstate commerce and are therefore required to comply with FDA enforced rules and regulations.

  • Immediate seizure of prohibited or illegal products by the US customs department

Prohibited products like narcotics and other drugs are banned from the United States and all custom officials are required to immediately seize any such product that is hazardous or poses a health risk.

  • Sampling of detained shipments

In situations where a certain good has been held by the US customs officials, the importer is allowed to take reasonable amounts to sample the product for analysis to prove compliance. If the product doesn’t comply with the FDA’s laws, the importer will then be held accountable by the customs authorities for the amount of goods missing if they are asked to redeliver the cargo for exportation or destruction.

While the FDA has very precise laws related to the production and distribution of food and drugs, these laws are not binding upon the public or upon the FDA. Therefore, personnel are allowed to use alternative tactics as far as the end result meets compliance with the applicable FDA regulations. So, be sure to do your research before applying for the FDA registration to ensure you don’t breach any of their policies, or simply get in touch with labs that specialize in facilitate the compliance inspection process.

About Author

This article is exclusive to Pharma Mirror Magazine readers and written by Edward Simpson who is a seasoned Calibration and Technical Engineer working for RS Calibration Inc. Edward has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and can be contacted anytime for matters related to machines. He also invites people to visit his company www.rscal.com  to learn more about the type of calibration work he does.

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