This batch release service offers companies the option of placing medicinal products with a marketing authorisation on the market without the need to establish a new or modify an existing QM system or to hire a Qualified Person.
QP Declaration
QPLab will evaluate the information regarding active substances manufacturing sites of the product, to assess the EU GMP compliance and issuing the QP Declaration.
QP Batch Certification Setup
In this step QPLab will have a complete oversight and understanding of the manufacturing process and supply chain, assuring an end-to-end process compliance with the EU-GMP in order to be able to start the Release/Certification of Batches for the EU space. All necessary documentation will be developed and approved at QPLAB in order to allow the batch Release/Certification process accomplishment.
Routine QP Certification of Batches
To accomplish the batch release/certification there are four steps considered:
– Scheduling timelines and updating information with client
– Batch testing and issuing of CoA (Certificate of Analysis)
– Batch documentation review and issuing of BRC (Batch Release Certificate)
– Continuous GMP compliance oversight, which includes the involved maintenance activities of QPLAB QMS and Product Quality Review assessment.
GMP Audits
The audits are to be performed by experienced and qualified auditors as per the orientation defined by EMA (Q&A Part II – #10). The audit will be performed in order to verify GMP compliance (Eudralex Vol. 4 – Part II). This service can be performed Worldwide.
Off-site audits can be performed to overcome travel restrictions issues.
Importation and Intermediate storage
This will be handled by a QPLAB partner, with GDP facilities, that will perform importation and warehouse handling during EU quarantine time until batch Certification and Release.
The service includes Customs Clearance, Reception, Conference, Storage and Expedition.
QA support
Team will be able to support QA activities locally if needed.