Active Substance Audits (APIs)

Active pharmaceutical ingredients (APIs) are the vital core of a medicinal product, producing its intended health effect. These active substances are manufactured from carefully selected raw materials and, when used in the strictly regulated production of medicinal products, exhibit a precisely defined chemical concentration.

A Good Manufacturing Practice (GMP) audit at your active substance suppliers gives you the assurance that your suppliers are able to meet the strict quality and safety requirements of the pharmaceutical industry. This gives you the opportunity to gain insight in advance and to ensure that your requirements are met.

Our experienced pharma-audit team has more than 20 years of practical experience in conducting audits at API manufacturers. Our declared aim is to ensure that you receive high-quality and safe active substances in order to maintain strict GMP compliance and to guarantee the quality and safety of your products for patients. Regardless of whether you source synthetic active substances, active substances from plant extracts or highly developed biotechnological active substances from your suppliers, we are at your side to qualify and/or audit these suppliers.

Manufacturing, control, documentation, packaging, storage and all other relevant steps must be carried out in accordance with the internationally recognised GMP guidelines. We check for you the careful compliance with these strict processes at your suppliers worldwide, taking into account the specific guidelines for the respective region.

Heacon offices in Shanghai, China and Bhopal, India

Many of your active substance suppliers are located in the pharmaceutical hotspots of Asia and Europe. Our operation sites in China and India enable us to conduct audits throughout the Asian region. In addition, our experienced team in Germany stands ready to coordinate active substance audits in Europe and the USA. This allows us to offer you our active substance audits at fair prices, no matter where you are located. Thanks to our extensive expertise and our global network, you can conserve valuable resources and still receive first-class GMP reports.

For each active substance audit we provide you with a team of two highly qualified auditors who have the necessary know-how in the field of pharma and GMP. An experienced lead auditor works closely with a co-auditor to ensure a comprehensive review. All our auditors are carefully selected and certified by our advisory board to ensure that they are optimally prepared for the specific requirements of each ordered audit. The CVs of our auditors are an integral part of our comprehensive audit documentation.

Our professional audit management keeps you informed of every step of the audit process – from the initial planning to the detailed evaluation of the measures taken. Thanks to our user-friendly web app you have full transparency at all times and can precisely track the progress of your projects as well as upload or download relevant data.