GMP Auditors | The FDA Group

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Conveniently access the industry's best GMP auditors wherever and whenever you need them.

Finding top GMP specialists in the hyper-competitive life science industries gets harder each day. With a large bench of auditors worldwide, including former FDA professionals, we meet your precise auditing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee.

Execute your audits on time and on budget with an individual GMP auditor or team of specialized resources. Dedicated project managers work closely with you to establish and track project milestones, schedule activities, guide resources, and report on success.

GMP Auditing Services »

What are GMP auditors and what do they do?

GMP auditors are professionals who have been trained and ideally certified to evaluate a company's manufacturing processes, with an emphasis on regulatory compliance. The ultimate goal of a GMP auditor is to ensure that a company's products are of high quality and safe for consumers—and that the company is operating in compliance with GMPs.

This may involve, but is not limited to:

Conducting inspections and audits of a company's facilities to verify that they meet GMP standards.
Reviewing and evaluating documentation, such as quality control records and Standard Operating Procedures (SOPs), to ensure that they comply with GMP regulations.
Providing expert guidance and support to companies to help them improve their manufacturing processes and meet GMP standards.

What makes for an effective GMP auditor?

There are several qualities we ensure all of our GMP auditors possess to be effective in their role. Some of these include:

Technical and regulatory expertise: A good GMP auditor should have a strong background in science or engineering, as well as a thorough understanding of GMP regulations and their application to life science manufacturing processes.
Attention to detail: GMP auditors need to be detail-oriented to thoroughly evaluate a company's manufacturing processes and ensure compliance with GMPs.
Communication skills: Auditors need to be able to communicate effectively with a variety of stakeholders, including company management, employees, and regulatory agencies.
Objectivity: GMP auditors should be objective and impartial in their evaluations and assessments to provide an accurate and unbiased assessment of a company's compliance with GMP regulations.
Flexibility: GMP auditing can be a dynamic and ever-changing field, and a good GMP auditor should be able to adapt to new situations and challenges as they arise.

Why work with an external GMP auditor?

There are many reasons companies hire GMP auditors. Some common situations include:

Preparing to undergo a regulatory inspection: If a company is expecting a regulatory inspection from an agency such as the FDA or EMA, it may choose to hire a GMP auditor to conduct a pre-inspection audit. This can help the company identify any potential areas of non-compliance with GMP regulations, and take steps to address any issues before the regulatory inspection takes place.
When a company is looking to improve its manufacturing processes: A GMP auditor can provide valuable insights and guidance on how to improve manufacturing processes to ensure compliance with GMP regulations. This can help a company improve the quality and safety of its products, and may also help them reduce the risk of product recalls or other regulatory action.
When a company is seeking third-party validation of its compliance with GMP regulations: A GMP auditor can provide independent verification that a company's manufacturing processes are in compliance with GMP regulations. This can be valuable for companies looking to demonstrate their commitment to compliance with GMP standards, and can also be useful for regulatory agencies that are responsible for enforcing GMP regulations.

You deserve a GMP auditing partner that lives and breathes life science.

We are that partner.

We don’t spread ourselves thinly across various industries. Instead, we focus on providing a deeper, richer bench of GxP talent at the rate you need. Our large staff of internal resources and extended global network offer access to specialists wherever you need them.

We help thousands of firms, including 17 of the top 25 global pharmaceutical, biotech, and medical device companies, connect with the specialists they need through the optimal workforce model.

Our GMP auditing services include: