What Is Regulatory Compliance According to FDA?

In this article, you will learn what is regulatory compliance according to the FDA requirements.

In the pharmaceutical industry, regulatory compliance means conforming to a rule, such as a specification, policy, standard, or law established in Code 21 of Federal Regulations of the United States.

Find out what is regulatory compliance as per cGMP.

FDA regulatory compliance process includes reviewing a regulated product, clearing products for sale, and maintaining post-market surveillance.

To understand what is regulatory compliance, you must know that it triggers the goal that organizations aspire to achieve in their efforts to commercialize their products inside the United States.

Why are companies looking at what is regulatory compliance?

It means that companies are aware of and take steps to comply with relevant laws, policies, and regulations enforced by the FDA in the United States and equivalent agencies in other countries.

All businesses have a certain set of regulations to which they must adhere to commercialize their products in each different country.

There are certain standards that the federal government requires all companies in the United States doing business interstate.

Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls contained for example in the ISO 9001, ISO 13485, etc.

Is your company in regulatory compliance with the CFR Code of Federal Regulations?

This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources in different countries.  Regulatory compliance varies by industry and by location. The rules, requirements, specifications, and regulatory structures in one country, maybe similar but with some significant differences in another country.

Some organizations keep compliance data—all data belonging or pertaining to the enterprise or included in the law, which can be used for the purpose of implementing or validating compliance—in a separate store for meeting reporting requirements. Compliance activities help companies manage their regulatory data more efficiently. This information may include calculations, data transfers, and audit trails.

What is the Compliance Program?

The Compliance Program Guidance Manuals (CPGM) provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. Compliance Programs are made available to the public under the Freedom of Information Act.

(See FDA Freedom of Information Act Handbook for Requesting Information and Records from FDA).

Even if you are working in the pharmaceutical industry, it is important to know the FDA compliance program guidance manual and the FDA regulatory procedures manual to better comply with the Federal Food and Drug, and Cosmetic Act.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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REFERENCES:

For more information about what is regulatory compliance, refer to:

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Search for FDA guidance documents, learn about the laws enforced by the FDA, and more.

httpss://www.fda.gov/regulatory-information

STATUTORY AND REGULATORY REQUIREMENTS

Federal Food, Drug, and Cosmetic Act (FD&C Act)

httpss://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act

Compliance Program Guidance Manual (CPGM)

httpss://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-guidance-manual-cpgm

Manual of Compliance Policy Guides

httpss://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/manual-compliance-policy-guides

Regulatory Procedures Manual

httpss://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/regulatory-procedures-manual

For more information about what is regulatory compliance, refer to:

httpss://www.fda.gov/drugs/guidance-compliance-regulatory-information

httpss://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals

httpss://www.fda.gov/regulatory-information/freedom-information