GMP/GDP compliance audits
Based on our experience and knowledge we organize GMP/GDP compliance audits of all our subcontractors in the field of:
- active substances manufacturing and storage sites (synthetic, biological, biotechnological and herbal substances),
- medicinal products manufacturing sites (solid, semi-solid, liquid and sterile or non-sterile forms),
- quality control laboratories,
- storage site of medicinal products, including physical importation sites,
- transport companies.
Such audits are also a part of preparation for inspection during GMP certification and obtaining of manufacturing authorisation. We assure the verification of quality system and assessment if manufacturing and/or distribution processes are conducted in line with applicable law.
Audits are equally important for investigational medicinal products (IMPs) in order to assure that IMPs are manufactured/distributed in accordance with GMP/GDP rules.
Audits can be conducted during whole product life-cycle, including its developmental phase. We always suggest performing of an audit as early as possible to avoid potential problems with manufacturing process and to limit possible deficiencies during the Inspections of relevant authorities. Early engagement and collaboration between parties is key to combine experiences and industry best practises.
Our offer also covers GMP/GDP trainings which can help to understand the audit findings and finally raise awareness and competence of your team.