In the recent years, the impact of pharmaceutical excipients on the quality and safety of medicinal products has become more and more a focus of interest. Usually the excipients constitute the largest material fraction in a drug product and often influence its pharmaceutical activity. Thus, in order to ensure premium-quality of excipients, an implemented effective quality assurance system at the excipient manufacturer (e.g. according IPEC) is indispensible.
Solid know-how and several years of experience in quality assurance of medicinal products, APIs and excipients, acquired from consulting projects in companies of various sizes and structures – this is how we make sure that You will have a tailor-made and effective quality assurance system that can confidently stand through authority inspections and customer audits.
In all this we are aware of the needs and the financial framework in the excipient industry, knowing that excipient manufacturers supply not only pharmaceutical companies with their products but typically also food businesses with other requirements.
Our services concerning pharmaceutical excipients:
- Mock auditing for identification of quality assurance deficiencies and weak points
- Set-up and optimization of integrated quality management systems, which consider requirements from the pharmaceutical, food and cosmetics industry
- Preparing new SOPs, harmonization and optimization of existing SOPs as well as consulting and support in SOP implementation
- Preparation for inspections, behavioral inspection training and escorting during authority inspections and customer audits
- In-house GMP seminars and trainings for lasting change towards GMP compliance