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Commercial & Corporate Law

What Legal Requirements and Compliance Do I Need for a Manufacturing Business?

updated:
9.2.21
Requirements and Compliance Manufacturing Business

There are various legal industry compliance requirements for manufacturing business in addition to different risks and compliance issues in manufacturing in order to obtain certificate of compliance manufacturing. Before starting a manufacturing business, you will need to obtain licenses and permits from various levels of the government, including at the federal, state and local levels.

What Manufacturing Permit Requirements and Licenses Do I Need?

There are various statutory and regulatory requirements in manufacturing industry that manufacturing company policies should take into account. The licenses required for manufacturing business and manufacturing permits include:

  • EIN or tax identification number from the federal government in addition to a similar tax ID from the business’s state of operation.
  • A basic license for operation of the business, obtained from the city or county where the manufacturing business will be located.
  • Land use and zoning permits covering the full breadth of your company’s operations.
  • Sales tax license permitting the sale of any goods manufactured by your company.
  • A health department permit if your company is manufacturing any food or other regulated products.
  • Building permits.
  • Special license required for manufacturing business if your company produces drugs, tobacco, alcohol, or firearms. To determine which permits are required, contact the U.S. Food and Drug Administration (“FDA”) or the U.S. Bureau of Alcohol, Tobacco, and Firearms.

What Is Manufacturing Regulatory Compliance?

What Is Manufacturing Regulatory Compliance

Manufacturing regulatory compliance includes a broad range of regulatory compliance procedures that protect businesses and consumers from risk. They set out the requirements for businesses to legally bring their manufactured products to market. Various production compliance areas can come into play in the process of bringing a product to market. Areas might include product safety, data protection, export controls, employment law, and fair competition, to name a few.

Any manufacturing product that is regulated by the FDA will be subject to additional regulatory compliance requirements, including under Title 21 of the Code of Federal Regulations Part 11 and Part 820. Part 11 obligates pharmaceutical manufacturers, medical device companies, biotech, and biologics development companies to implement specific controls, including audits, electronic signatures, and other forms of documentation requirements. If a business manufactures an FDA-regulated product, it is important to verify any additional regulatory or compliance obligations that may apply.

Different Types of Compliance and Manufacturing Certificates

There are various types of compliance that are of particular importance to manufacturers. These include:

  • HIPAA (Health Insurance Portability and Accountability Act of 1996): this is a federal law requiring standardization of mechanisms for protecting sensitive patient health information from being disclosed without explicit consent from the patient.
  • PCI-DSS (Payment Card Industry Data Security Standard): this regulation applies to companies that handle major branded credit cards and is designed to protect the cardholder’s data that is shared, processed, or stored during a transaction.
  • SOC 2 (Systems and Organization Controls): this describes a suite of reports that are reported during an audit that is intended to be used to validate internal compliance controls.
  • SOX (Sarbanes Oxley Act of 2002): this Act outlines requirements for all private and public companies who are handling financial data.
  • ISO (International Organization of Standardization): the ISO is an international body that sets industry standards.
  • GDPR (General Data Protection Regulation): this governs the EU General Data Protection Regulation replaced the EU Data Protection Directive and its local implementing laws. The GDPR requires companies who process personally identifiable data in the EU to demonstrate compliance with its requirements.

Any manufacturing business with international operations should also be aware of key international industry standards for compliance issued by the International Organization for Standardization (“ISO”) including:

Why Is Manufacturing Compliance Important?

Why Is Manufacturing Compliance Important

If a business has compliance issues or risks in manufacturing, the stakes can be high. Failure to comply with manufacturing compliance requirements risks your business’s financial and reputational health. In addition, it exposes your business to legal liability and to production/manufacturing delays.

Benefits of Manufacturing Requirements Compliance

There are several benefits to developing a robust manufacturing compliance program. To name a few:

  • Reduced risk to the business, including to both employees and customers.
  • Efficient communication within the business because employees are aware of compliance requirements and issues and are encouraged to flag issues with management and fellow workers.
  • Reduced financial cost of regulatory violations or delays in getting your product to market
  • Minimizing harm to consumers

How to Get a Certificate of Manufacturing Compliance?

To obtain ISO certification and statutory compliance for the manufacturing industry, your business must find an accredited certification body that uses the relevant Committee on Conformity Assessment (CASCO) standards.

How to Implement a Manufacturing Corporate Compliance Plan?

How to Implement a Manufacturing Corporate Compliance Plan

When implementing a manufacturing corporate compliance plan, there are various steps to consider and take to meet manufacturing requirements and to obtain a factory compliance certificate.

Research

Your business should start by researching any regulatory requirements that apply to the product you are manufacturing. This research will focus on any state or country-specific regulations in addition to any additional compliance requirements imposed by federal agencies like the FDA.

Set Goals and Understand Risks

Next, business stakeholders should meet and discuss any perceived or known compliance risks in manufacturing that exist. Stakeholders must set goals to address these deficiencies or to create a stronger comprehensive compliance program. The business should focus on developing a robust compliance training program for employees.

Provide Manufacturing Compliance Training to Employees

After designing the compliance training program, the business should set aside time to conduct the training and to answer any questions that may arise during that training. Ensuring that employees are aware of compliance procedures is vital to the effective functioning of a manufacturing compliance program.

Make Compliance an Ongoing Effort

As part of this training, your business should emphasize the ongoing nature of compliance efforts. Namely, you should emphasize that compliance needs are always evolving and changing and that it is the role of each employee to remain diligent about compliance efforts, especially as your business continues to grow and scale.

Conclusion

At Sequoia Legal, we know that complying with the various regulations and standards required to start and operate a manufacturing business can be burdensome. We are here to help you navigate these complicated compliance requirements so that you can focus on growing your business.

For more information, contact our expert legal team today!

Written by:

Hunter Boone

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