Batch certification for Medicinal Products/ Investigational Medicinal Products
Batch certification – what does it mean?
Every batch of investigational or market authorized medicinal product used in the European Union has to be certified and released by a Qualified Person (QP).
Batch certification of already approved medicinal product is defined as a QP confirmation that the batch is of good quality and has been manufactured in compliance with EU GMP (Good Manufacturing Practice) and in compliance with MA (Marketing Authorisation).
In terms of Investigational Medicinal Products, QP is responsible for certifying that each batch of IMP has been manufactured and tested / checked in accordance with:
- EU GMP
- The Product Specification File
- The IMPD (Investigational Medicinal Product Dossier) or the CTA (Clinical Trial Authorisation)
- The Product Specification File (according Annex 13 to the EU GMP Guideline)
Product certification is a matter of critical importance for several key reasons:
Safety and Quality Assurance: At its core, product certification guarantees that a product is not only safe but also meets established quality standards. This is crucial for products that directly impact patient safety.
Legal Compliance: Non-compliance can lead to market entry denials or costly recalls, jeopardizing the financial and reputational health of manufacturers and importers.
As a result of the certification process, the batch certificate (“quality release”) is a guarantee of the quality, effectiveness and safety of the product for the patient.
SciencePharma – knowledge and experience
SciencePharma offers batch certification and release of:
– Medicinal Products (MPs) intended for the market,
– Investigational Medicinal Products (IMPs) for clinical trials by a Qualified Person.
Qualified Persons at SciencePharma are high-level specialists within many years of experience and continuous expansion of their knowledge, ensure that the batch certification process is carried out professionally and with attention to any details.
We have a wide experience in batch release and certification of the medicinal products and investigational medicinal products derived from both the EU local market and from third countries. Our activities include assessing GMP issues, participating in inspections and audits at sites involved in the manufacturing and distribution of MP/IMPs, being involved in complaint handling and recall processes. We deal with all aspects related to the organization of analytical batch release tests performed in the European Union in contract laboratories audited by SciencePharma. Efficient cooperation with contractors and control of product life-cycle limit of possible problems with product quality in the future. Our practice includes certification and release of different pharmaceutical forms of medicinal products, including sterile ones.
Comprehensive Batch Certification and Release Services for Your Products
Our team of specialists offers a comprehensive service for the certification and release of batches product. We provide a professional approach in the evaluation of each batch. By working with us, we guarantee to certify each batch of your product safely and efficiently. With years of experience and in-depth knowledge about the certification requirement process, our experienced specialists are your trusted guides throughout the entire journey of the certification.
SciencePharma will ensure your products meet the necessary standards, streamlining the certification process and providing expert assistance every step of the way.
Certify with SciencePharma
With knowledge and experience offered by our specialists, we provide a comprehensive batch certification service for both the medicinal product and the investigational medicinal product. The trust and positive opinion of our Clients confirm the professionalism and commitment we put into the services we provide. For more information on the possibility of cooperation, please contact us directly.