All our QP's have experience across a wide range of product types and dosage forms. They have the authorisation by the authorities to release pharmaceuticals, biologicals, IMP´s, ATMP's and medical devices for clinical and commercial use in compliance with GMP, GCP and Annex 16. Our QPs are assigned projects according to their specialist expertise and have personal and legal responsibility as defined by the EU Clinical Trial Directive (2001/20/EC).
- Global auditing of third party manufacturing, testing, packaging and labelling facilities as required in support of QP declarations for import into the EU
- Microbiological investigation according to the pharmacopoeia (not sterile)
- QP Declaration: to confirm that the active ingredient is manufactured in accordance with detailed EU GMP guidelines
- Product Specification Files (PSF): is a reference file containing all the quality information related to your IMP. The content can vary depending on the product and stage of development. It is the basis for QP certification.
- QP Batch Confirmation: a statement confirming, that the product has been conducted in accordance with EU GMP and PSF standards.
- QP Certification and Batch release: a finished product must be certified and released by a QP. Certifying form of documentation that the final kits can be used in your study, representing the quality of the batch’s release.
We also have an experienced support team that can advise you on releasing IMPs for use in clinical trials, including importing into the EU if required.
In addition to the qualifications and audits mentioned above, NextPharma can provide already qualified suppliers, manufacturers and laboratories.