Pharma industry

3 February 2025

Pharmaceutical audits: definition, objectives, methods, and importance

Pharmaceutical audits play a key role in the pharmaceutical and nutraceutical industries. They ensure compliance with quality standards, regulatory requirements, and manufacturing processes at every stage of pharmaceutical production.

In this article, we detail what a pharmaceutical audit is, why it is necessary, and its procedures to ensure pharmaceutical regulatory compliance and product safety, particularly the quality of pharmaceutical packaging.

Develop your own solution

conducting a pharmaceutical audit in accordance with regulatory requirements.

Table of contents

1. What is a pharmaceutical audit?
2. Why conduct pharmaceutical audits?
3. The procedures for pharmaceutical audits
4. The impact of pharmaceutical audits on supplier relationships

1. What is a pharmaceutical audit?

a. Definition of a pharmaceutical audit

A pharmaceutical audit is a systematic evaluation of the processes, systems, and infrastructure involved in the manufacturing, monitoring, and distribution of pharmaceutical products.

It ensures that all activities comply with regulatory requirements and international quality standards, such as Good Manufacturing Practices (GMP) and ISO standards (ISO 9001, ISO 15378…), implemented in the pharmaceutical industry.

Explore how our double-tip drinkable ampoules can elevate your projects: request our brochure today!

b. The different types of pharmaceutical audits

There are 3 types of pharmaceutical audits:

Internal pharmaceutical audits: Conducted by a company’s internal teams to verify its own processes.
External audits: Carried out by third-party organizations or regulatory authorities to ensure compliance.
Pharmaceutical supplier audits: Performed by a company to assess the quality of its suppliers’ products or services.

2. Why conduct pharmaceutical audits?

a. Ensuring regulatory and safety compliance

Audits enable pharmaceutical companies to comply with the requirements of health agencies such as ANSM in France, FDA in the USA, and EMA in Europe. They also ensure that products are manufactured according to strict standards aimed at safeguarding patient and consumer safety.

ANSM: In France, the National Agency for the Safety of Medicines ensures the quality, safety, and efficacy of medicines. It grants marketing authorizations (AMM), monitors adverse effects, and inspects production sites in accordance with Good Manufacturing Practices (GMP).
FDA: In the United States, the Food and Drug Administration regulates pharmaceuticals and medical devices. It approves new products, inspects manufacturing facilities, and ensures compliance with current Good Manufacturing Practices (cGMP) to guarantee patient safety.
EMA: In Europe, the European Medicines Agency harmonizes the evaluation and authorization of drugs across the region. It manages centralized marketing authorizations (AMM), ensures pharmacovigilance, and collaborates with national agencies.

ISO standards in the context of pharmaceutical audits

ISO standards contribute to the quality of pharmaceutical packaging. To learn more about ISO standards in the pharmaceutical industry, check out our complete article.

b. Optimize the quality of pharmaceutical products

Quality audits in the pharmaceutical industry are key drivers in preventing failures during production and ensuring a high level of quality.

Opt for our double-tip drinkable ampoules: request our brochure here!

c. Minimizing risks and ensuring continuous improvement

By identifying potential defects, audits help anticipate and resolve issues before they impact the quality of pharmaceutical packaging. This proactive approach promotes continuous improvement and reduces long-term costs.

3. The procedures for pharmaceutical audits

a. Who carries out pharmaceutical audits?

Pharmaceutical audits are conducted by:

Internal auditors: trained in GMP and current regulations.
Specialized third-party organizations: for independent expertise.
Local regulatory authorities (ANSM in France, EMA in Europe, FDA in the USA, Health Canada in Canada).

b. Frequency and planning of pharmaceutical audits

Audits are conducted at regular intervals:

Internal audits: Conducted annually or semi-annually.
Supplier audits: Depending on the risk level associated with the products or services.
Regulatory audits: Conducted by competent authorities and unannounced.

c. Cost and return on investment

The cost of a pharmaceutical audit varies depending on its objective and scope. The investment is generally offset by the savings achieved through the prevention of non-conformities and product recalls.

Pharmaceutical supplier audits ensure compliance with Good Manufacturing Practices (GMP). To learn more about GMP, check out our dedicated article.

Good Manufacturing Practices (GMP) in pharmaceuticals

d. Documentation and record-keeping of pharmaceutical audits

Audits require rigorous documentation to track observations and monitor the corrective actions taken.
This traceability is essential to demonstrate pharmaceutical regulatory compliance during future inspections.

4. The impact of pharmaceutical audits on supplier relationships

Pharmaceutical audits help build a relationship of trust between pharmaceutical suppliers and manufacturers.

At SFAM, we conduct regular and rigorous audits to ensure the quality and compliance of our products.

Here are a few key points:

Systematic inspections: 100% of ampoules are visually and automatically inspected. This is supplemented by random checks by the quality department.
Use of safe materials: such as ILLAX® and FIOLAX® glass, resistant to high temperatures and chemical transfers with content.
Technical advantages: DRB (Double Ring Break) pre-scoring for a safe opening and reduced glass particle generation.

Opt for our double-tip crushable ampoules and elevate your projects. Check out our brochure or request a quote here!

Our latest news