EU QP Batch Certification
Ensuring compliance and quality for your pharmaceutical products with QP release service
Final batch release to the EU market
The process of EU QP (Qualified Person) release is a crucial regulatory obligation, encompassing a set of quality control steps that must be adhered to before a pharmaceutical batch is authorized for sale or distribution in the EU.
Within the European market, no medicinal batch can be made available for sale or distribution until it receives certification from a Qualified Person.
To streamline your product sales in Europe, Profarma’s QP ensures the commitment to quality and regulatory compliance before products can enter the market.
Frequently asked questions
We have our own QP, can we use Profarma for release testing?
Absolutely. In such a situation, Profarma will perform batch release testing and issue a Certificate of Analysis for your QP to further release the products.
What types of products can Profarma handle for QP batch release?
Profarma can manage QP batch release for a variety of pharmaceutical products, including:
- Small molecule drugs
- Biologics and biosimilars
- Sterile products
- Investigational medicinal products (IMPs)
- Over-the-counter (OTC) products
How can I start the QP batch release process with Profarma?
To start the process, contact us through our website. Our team will guide you through the requirements and steps needed to certify and release your product batches in compliance with EU regulations.
How long does the QP batch release process take?
The duration of the QP batch release process can vary depending on the complexity of the product and the completeness of the documentation. Typically, it can take a few days to several weeks to complete the process.