The ISO standards in pharmaceuticals: a complete guide

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.