Quality assurance

ABL’s manufacturing and QC testing functions are GMP licensed in accordance with EMA regulations.

GMP inspections are performed routinely by the French regulatory authorities.

ABL’s quality system management and GMP compliance is assured by ABL’s Quality Unit.

Each site has a designated Qualified Person (QP), and ABL Europe has 3 QPs available to perform GMP certification according to EudraLex Volume 4, Annex 13.

QA GMP batch release is performed by ABL by issue of the following documentation, with electronic copies are made available to the client;

  • QA approved executed batch records
  • A Certificate of GMP Conformance
  • A Certificate of Analysis
  • Quality audits by clients as part of the vendor selection process are welcomed by ABL.  ABL’s facilities have been audited and approved by biotech and Pharma companies worldwide for all phases of clinical supply.