Difference Between Regulatory affairs (RA) and Quality Assurance (QA)

What is Regulatory Affairs?

Professionals in this field implement regulations from local, state and federal governing bodies to ensure compliance. They also stay up to date on the latest policy changes and recommend new organization protocols as necessary. RA professionals work in Bio pharmaceutical, pharmaceutical and medical devices industries

What is Quality Assurance (QA)?

QA on the other hand, ensures a company’s products meet quality standards for distribution to the market. These include both internal and industry standards, as well as safety standards set by local, state, national, and international governing bodies. QA professionals can work in pharmaceutical, Bio pharmaceutical, nutraceutical companies.

What is the difference between RA and QA?

While the roles and responsibilities of professionals working in regulatory affairs and quality assurance sometimes overlap, but following are few differences:

1. Work environment

Quality assurance professionals usually work for a company's internal quality department, but regulatory affairs professionals may work in internal or external positions.

2. Duties

These professionals perform many of the same duties to fulfill their job description.For instance, they might review legal policies and implement company protocols to ensure compliance.Other common duties include:

- Visiting manufacturing plants to supervise production procedures.

- Reporting violations to the appropriate regulatory agenciesReporting violations to the appropriate regulatory agencies

- Communicating with other regulatory affairs or quality assurance professionals to consistency.

3. Job outlook

As both the departments are equally important to pharmaceutical companies, but still most of the companies don't have proper Regulatory affairs departments in some countries pharmaceutical industry instead, they perform their regulatory activities with the help of consultants, out source agencies or sometimes Plant managers perform such duties.However, QA department is mostly present in almost all pharmaceutical, neutraceutical companies.Hence, more job opportunities for QA professionals!As Regulatory affairs is in transition phase in some countries( pharmaceutical industry).

4. Goals

Regulatory affairs and quality assurance professionals have similar goals.Both roles require the delivery of high-quality products that satisfy the customer's safety expectations! As a result, their duties promote the positive reputation of the company and help maintain overall brand loyalty.For instance, consider a regulatory affairs professional who oversees the development of a new pharmaceutical drug. Adherence to legal regulations promotes the safety of employees and safeguards the company from lawsuits. A quality assurance professional goals could involve everything from making the drug as effective as possible to developing attractive product packaging.

Read also: Difference Between 505(b)(1) and 505(b)(2)

Resource Person: Diwakar Shukla

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