Quality assurance

To improve the quality of our products and services continously is our daily commitment and incentive. Therefore, our quality standards comply with the requirements of the European GMP guidelines and the regulations of the United States FDA. In addition to that they are the subject to regular audits by national and international authorities and our customers.

Our analytical and microbiology laboratories are set up to meet the requirements of modern instrumental analysis. We carry out the majority of our analytical work in-house. We entrust special analyses to contract laboratories that are monitored using the inspection programme associated with our quality management system.

All the processes performed within our company are subject to a comprehensive qualification and validation programme. When validating new products, for example, we safeguard the quality of our processes and our products by using the HACCP concept.


HACCP concept

HACCP stands for Hazard Analyses and Critical Control Points. In the pharmaceutical industry HACCP is a management tool to examine and control quality risks. It enables a structured and logistical approach to quality problems.
hameln pharma uses HACCP when it comes to the validation of new products to ensure the quality of the process and the product.



Our products go with you to theproverbial world´s end. At the moment we are producing for more than 70 markets worldwide and since 1987 we are audited regularly by international authorities. Furthermore approximately 25 customer audits per year assure you of the fact hat our manufacturing environment always meets statutory requirements and that your products is in good hands with us.