Batch release by QP

QP services are indispensable when it comes to introducing third country products to the EU market.

Imported pharmaceutical products are tested and analysed after analytical method transfer, in accordance with the applicable regulations laid down in the Phamacopoeia.

Our GMP certified laboratory ensures in this process the performance of the analytical and microbiological tests required for product release.

The Qualified Person (QP) of WESSLING releases the product on the basis of the Certificate of Analysis which we issue.

QP services

Pharmaceutical companies achieve full compliance with and full satisfaction of the applicable statutory requirements (QP certification and product release) through the services provided by our QP. We create all GMP related documents and we arrange third part audits for our domestic and international customers.

Our services:

  • Assumption of responsibility as qualified person (QP)
  • Issuance of QP certificates
  • Performance of audits (sterile and nonsterile manufacture, raw material manufacture audits),
  • Creation of GMPrelated documents (e.g. annual PQR)
  • Support for the creation and continued development and improvement of quality assurance systems.