Excipient audits
The inactive element of the medicinal product
Excipients play a crucial role in stabilizing, increasing the volume and improving the absorption of medicinal products or active ingredients.
They prevent the decomposition of medicinal products and contribute to improving or enhancing the taste of finished products, which is why they are considered the inactive element of the medicinal product.
A regular GMP audit for excipient manufacturers in accordance with the Excipients Guidelines (Guidelines dated March 19, 2015 for formalized risk assessment to determine appropriate good manufacturing practices for excipients of medicinal products for human use) and the Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients, published by the International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG), is essential.
This audit ensures control over the manufacture, documentation and testing of excipients and guarantees you the highest quality of excipients used.
Similar to APIs or primary packaging materials, excipients are an integral part of the product that is ingested 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 check all processes in the production of excipients.
These audits allow you to become familiar with your supplier and ensure that the excipients supplied meet your requirements and quality standards.
Heacon offices in Shanghai (China) and Bhopal (India)
Many of the most important excipient manufacturers for the European market are located in Asia, particularly 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 GMP, including excipient manufacturing.
Our local experts are regularly qualified and approved through internal processes.
You can find out more about our international team here.
Our audits of API suppliers, primary packaging suppliers and excipient suppliers (including contract manufacturers, if applicable) enable you to bring high-quality and safely manufactured products to market.
Get in touch with us at audit@heacon.de or visit pharma-audit.appto schedule your next audit.
