Excipient Audits

Excipients play a decisive role in stabilising, increasing the volume and improving the absorption of medicinal products or active substances. They prevent the decomposition of medicinal products and contribute to improving or enhancing the taste of finished products, which is why they are regarded as the inactive element of the medicinal product.

A regular GMP audit for excipient manufacturers in accordance with the Excipients Guidelines (Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use) as well as the Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients, published by the International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG), is of decisive importance. This audit ensures control over the manufacturing, documentation and testing of excipients and guarantees you the highest quality of the excipients used.

Similar to APIs or primary packaging materials, excipients are an integral part of the product that is taken directly by the patient. Any deficiencies in the quality of these substances could potentially endanger the health of patients. Our task is to audit these manufacturers on site and to review all processes in the manufacturing of the excipients. Through these audits you become familiar with your supplier and can ensure that the excipients supplied meet your requirements and quality standards.

Heacon offices in Shanghai (China) and Bhopal (India)

A large number of the most significant excipient manufacturers for the European market are located in the Asian region, in particular in China and India. We have two Operation Units in China and India, each with a team of experts from the pharmaceutical industry. Our teams in both countries have extensive experience in the GMP field, including the manufacturing of excipients. Our experts on site are regularly qualified and released through internal processes.

Through our audits at API suppliers, primary packaging material suppliers and excipient suppliers (also at contract manufacturers, if available), you can bring high-quality and safely manufactured products to market.