Pharmaceutical manufacturer validating their company's ISO standards.
The ISO standards in pharmaceuticals: a complete guide
Industrie pharmaceutique / Pharma industry

The ISO standards in pharmaceuticals: a complete guide

ISO standards are essential in the pharmaceutical industry. They ensure the quality, safety, and compliance of products. This article explores pharmaceutical ISO standards, their differences from GMP, and details the key ISO standards in the pharmaceutical industry.

1. What are ISO standards ?

a. Definition of ISO in the pharmaceutical industry

The ISO (International Organization for Standardization) is an independent, non-governmental global body that sets voluntary international standards to ensure the quality, safety, and compliance of products and services. ISO standards are recognized worldwide and cover various industrial sectors, including the pharmaceutical industry.

b. The difference between ISO standards and GMP

GMP (for ‘Good Manufacturing Practices’), or BPF in French (for ‘Bonnes Pratiques de Fabrication’) apply to various sectors such as the pharmaceutical and nutraceutical industries. They regulate the production and quality control of medications, dietary supplements or cosmetics.

Unlike ISO standards, which are voluntary, GMP (Good Manufacturing Practices) are often legal requirements enforced by regulatory agencies (such as the ‘FDA’ in the United States or ‘ANSM’ in France). Therefore, ISO standards and pharmaceutical GMP work together to ensure even higher levels of quality, safety, and compliance.

At SFAM, we have chosen to implement ISO 9001 and ISO 15378 standards. Learn more about SFAM’s ISO standards.

2. ISO standards in the pharmaceutical industry

a. The benefits of ISO standards

ISO standards cover all processes involved in the design and manufacture of products, from Research and Development to distribution, including manufacturing.

Adopting ISO standards offers significant advantages to pharmaceutical manufacturers by helping to:

  • Standardize and streamline processes.
  • Improve the quality, reliability, and safety of products.
  • Enhance regulatory compliance.

Overall, ISO standards help increase consumer satisfaction and trust.

The standards also provide a framework for pharmaceutical audits that aim to ensure adherence to operational processes and compliance with pharmaceutical GMP through a detailed checklist.

Combining ISO standards with pharmaceutical GMP allows drug manufacturers to strive for excellence in terms of quality, safety, and compliance.

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b. The main ISO standards for the pharmaceutical industry

  • ISO 9001 :
    ISO 9001 is a standard focused on quality management. It helps companies ensure that their products and services meet applicable regulations. In the pharmaceutical industry, it allows for the standardization of processes, improvement of operational efficiency, and reduction of non-compliance risks.
  • ISO 15378 :
    ISO 15378 specifies the requirements for materials used in primary pharmaceutical packaging. It includes GMP (Good Manufacturing Practices) and ensures that materials used for primary pharmaceutical packaging, such as SFAM’s double-tip glass ampoules, are manufactured and controlled in accordance with quality standards.
  • ISO 14001 :
    ISO 14001 is an environmental management standard that guides companies in managing their environmental responsibilities. It ensures that industrial operations comply with environmental regulations, minimize waste, and reduce ecological impact.
  • ISO 17025 :
    ISO 17025 pertains to the competence of testing and calibration laboratories, ensuring that they perform tests reliably and accurately. In the pharmaceutical sector, this standard guarantees that quality tests and analyses are conducted properly.

3. The ISO certification process

The ISO certification process is comprised of several stages :

  1. Initial analysis : evaluating existing processes and identifying gaps compared to the standard’s requirements.
  2. Planning : an action plan to align processes with the targeted ISO standard’s requirements.
  3. Implementation : adapting these processes, training personnel, and establishing new procedures.
  4. Internal audit : conducting internal audits to verify compliance with the standard’s requirements.
  5. Certification audit : an independent certification body conducts an audit to assess conformity to ISO standards.
  6. Certification : if the certification audit is successful, the company receives an ISO certification.
  7. Continuous monitoring : after certification, ensure the maintenance of compliance through regular internal audits and periodic reevaluations by the certification body.

In conclusion, pharmaceutical standards and Good Manufacturing Practices (GMP) are fundamental for pharmaceutical companies and their subcontractors. Together, they ensure quality, safety, and compliance, and help strengthen consumer trust.