Active pharmaceutical ingredient audits (APIs)
High-quality and safe active ingredients
Active pharmaceutical ingredients (APIs) are the vital core of a medicinal product that produces its intended health effect.
These active ingredients are produced from carefully selected raw materials and have a precisely defined chemical concentration when used in the strictly regulated production of medicinal products.
A Good Manufacturing Practice (GMP) audit of your material suppliers gives you the assurance that your suppliers can meet the strict quality and safety requirements of the pharmaceutical industry.
This gives you the opportunity to gain insight in advance and ensure that your requirements are met.
Our experienced pharma-audit team has more than 20 years of practical experience in conducting audits of API manufacturers.
Our goal is to ensure that you receive high quality and safe APIs to maintain strict GMP compliance and guarantee the quality and safety of your products for patients.
Whether you source synthetic APIs, botanical extract APIs or advanced biotechnology APIs from your suppliers, we are here to help you qualify and/or audit these suppliers.
Production, control, documentation, packaging, storage and all other relevant steps must be carried out in accordance with internationally recognized GMP guidelines.
We check for you that your suppliers worldwide carefully comply with these strict processes, taking into account the specific guidelines for the respective region.
Heacon offices in Shanghai, China and Bhopal, India
Many of your active ingredient suppliers are located in the pharmaceutical hotspots of Asia and Europe.
Our operational sites in China and India enable us to conduct audits throughout Asia.
In addition, our experienced team in Germany is ready to coordinate API audits in Europe and the USA.
This enables us to offer you our active substance audits at fair prices, no matter where you are located.
Thanks to our extensive expertise and global network, you can save valuable resources and still receive first-class GMP reports.
For each API audit, we provide you with a team of two highly qualified auditors who have the necessary expertise in the pharmaceutical and GMP sectors.
An experienced lead auditor works closely with a co-auditor to ensure a comprehensive review.
All our auditors are carefully selected by our advisory board The auditors are selected and certified to ensure that they are optimally prepared for the specific requirements of each audit ordered.
The CVs of our auditors are an integral part of our comprehensive audit documentation.
Our professional audit management keeps you informed about 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 and upload or download relevant data.
Simply register to become part of the active pharma-audit community!
Register in our web app pharma-audit.app and order your next active pharmaceutical ingredient audit with just one click.
Do you have specific questions or concerns that require personal clarification?
Please do not hesitate to contact us at any time. We are happy to assist you with our comprehensive expertise in the pharmaceutical and GMP sectors.
