Finished medicinal product audits
GMP conformity of the entire system
As the name suggests, finished medicinal products are not merely active ingredients or intermediate products, but fully finished products that are ready for distribution to the consumer.
Manufacturers of finished medicinal products are subject to strict certification requirements and must ensure that the manufacture, packaging, labeling, storage, transport and control of both the finished medicinal products and the starting materials used comply with Good Manufacturing Practice (GMP) standards.
Regardless of whether the manufacturers produce solid, liquid, semi-solid, sterile or non-sterile finished medicinal products, our audits of your finished medicinal product manufacturers check the conformity of the entire system with the relevant GMP guidelines.
This includes, for example, the EU GMP Part I guidelines with all associated annexes for the European market.
Our aim is to help you provide high-quality and safe products for your customers.
Our customized audits for finished medicinal products enable us to shed light on individual aspects of your business.
We prepare detailed and high-quality reports for you.
Our experienced experts focus on your questions and key areas to be addressed during an audit.
We prepare comprehensive GMP audit reports that not only provide you with the highest quality results, but also save you time, effort and resources.
Finished medicinal product audit worldwide
Our globally available team of qualified and experienced auditors adapts flexibly to your requirements and guarantees uncomplicated and efficient processing.
Our audit experts are familiar with the current guidelines and carry out audits for various markets, whether in Europe, the USA, Japan or China.
Their valuable experience is at your disposal to provide you with the best possible support.
For every audit of finished medicinal product manufacturers, we provide you with a team of at least one experienced lead auditor with the appropriate expertise.
Our proven standard process ensures that both a lead auditor and a co-auditor are scheduled for each audit.
All our auditors undergo a rigorous qualification process, including a Wittnes audit, so that they are optimally prepared for the requirements of each individual audit.
Our auditors’ CVs are an important part of our comprehensive audit documentation and can be downloaded from our user-friendly web app once the audit has been ordered.
Special focus: sterile production
Of course, there are also manufacturing areas that have to meet special requirements.
These include, of course, products made from human blood or plasma (Annex 14), radiopharmaceuticals (Annex 3) and, above all, all sterile manufacturers (Annex 1).
In these cases, the auditors are selected with particular attention to experience and knowledge in the relevant areas.
In this way, we ensure that (in the example of sterile products) the topics of employee qualification, media fill and microbiological analyses are considered in a particularly qualified manner.
Our audit management keeps you informed about every step of the audit process – from the initial planning to the final evaluation of the measures taken.
Our innovative web app gives you full transparency – you can track the progress of your projects at any time and upload or download relevant data.
By simply registering, you can become part of the active pharma-audit community!
Register on our user-friendly web app and order your next finished drug product audit with just one click.
If you find an audit report in our database that does not exactly match your finished medicinal product, don’t worry!
We will carry out a supplementary audit (remote or on-site) for you at this manufacturer.
In this comprehensive audit, all relevant processes, specific issues and documents relating to the manufacture and testing of your product are addressed.
The result is a complete, individual and detailed finished medicinal product audit report that helps you to ensure the quality and safety of your product and to pass regulatory inspections with confidence.
Here you have the opportunity to order your next GMP audit from your finished medicinal product manufacturer and benefit from our comprehensive service.
