ISO standards play an important role in the pharmaceutical industry in ensuring the quality, efficacy and safety of drugs. These standards help to standardize the manufacturing, testing, storage and distribution processes for drugs on a global scale. ISO stands for International Organization for Standardization. This international organization was founded in London in 1946 and has been dedicated to creating internationally valid standards ever since.

Some important ISO standards (German translation: ISO-Normen) that apply to the pharmaceutical industry include:

• ISO 9001
  This standard specifies the requirements for an organization’s quality management system and is suitable for all types of companies, including pharmaceutical companies. ISO 9001 requires organizations to demonstrate that they are able to deliver products and services that meet customer and regulatory requirements.

• ISO 15378
  This standard is specifically designed for manufacturers of primary packaging for pharmaceuticals. It includes the basic GMP (German: Gute Herstellungspraxis) requirements and deals with quality management. In addition, this standard also deals with the steps in packaging manufacture that come into direct contact with the product. This standard helps to ensure that the packaging does not compromise drug quality.

• ISO 13485
  This standard deals with quality management systems for manufacturers of medical devices (translation into German: Medizinprodukte). It is similar to ISO 9001 but contains specific requirements relating to compliance with laws and regulations in the medical device sector. Although it focuses primarily on medical devices, many aspects of the standard can also be applied to the pharmaceutical sector, particularly in relation to quality assurance and the reliability of processes and products.

• ISO 17025
  This standard deals with the competence of testing and calibration laboratories (German translation: Prüf- und Kalibrierlabore). It recognizes their ability to deliver accurate and reliable results, which is also crucial for quality control in the pharmaceutical industry.

Advantages of using ISO standards in pharmacy

• Improved product quality: Standardized processes help to reduce deficiencies and errors in production while also ensuring consistent quality.
• Higher levels of trust from customers and regulatory authorities: Certification according to international standards strengthens manufacturers’ reputations and can simplify market expansion.
• Optimization of production costs: Cost reduction by reducing waste and improving process efficiency.

The ISO standards used in the pharmaceutical industry therefore play a key role in ensuring the quality and safety of drugs, which has a direct impact on the health and well-being of consumers.

We provide professional language services for GMP inspections or audits of your pharmaceutical company and look forward to your inquiry. Our pharmaceutical interpreters and GMP translators provide on-site interpreting and specialist translations of your pharmaceutical documents.

In addition, we are also happy to provide you with consultancy services in the run-up to a GMP inspection, representation of international pharmaceutical companies and distribution of their products in Germany. Thanks to our long-standing cooperation with many pharmaceutical companies around the world, we can also support you if you are looking for a new challenge in the pharmaceutical industry.