Supplier Audits

As Sr. Quality (Lead) Auditor for pharmaceutical customers, De Jong Pharma Consult has an extensive experience in conducting audits. Over the years more than 400 supplier audits have been performed. Supplier audits are performed at e.g.:

  • Contract manufacturers: Sterile, non-sterile, medical devices and combination products as well as CRO’s performing activities in the Clinical Supply Chain.
  • Packaging and Distribution service providers, including 3PL’s
  • Clinical supply chain service providers performing labeling, blinding, named-patient etc. activities
  • Suppliers of:
    • API’s
    • Excipients
    • Primary, Secondary packaging materials
    • Printed packaging materials/components such as Leaflets, Folding Cartons, Labels, Patient cards etc.
    • Critical services such as Pest Control and Calibration services

These supplier and contract manufacturers have been active in both regular (bulk) manufacturing of products and/or the clinical supply chain.

Contract Manufacturers and Suppliers are audited towards the regulation and guidelines specified by the client or most suitable for the activities. Guidance that we audit against are e.g.:

  • US GMP: 21 CFR 210/211/212, 820
  • EU GMP: Eudralex Volume 4, parts I, II, III and all Annexes
  • EU Good Distribution Practices
  • ISO 9001, 13485, 15378, 17025, as primary guidance
    • As well as 14971, 11135, 11137, 11138, 14161, 14644 etc. as secondary guidance, supporting audits against the primary guidance. 
  • ICH guidelines: Q 7, 8, 9 and 10
  • Korean GMP
  • Japanese GMP
  • ISPE guidelines

Last but not least, De Jong Pharma Consult is an expert in radiolabeled pharmaceuticals and biomarkers and their related guidelines.

Although our experience regarding GMP in the Clinical Supply Chain is vast, De Jong Pharma Consult does not provide GLP and/or GCP expertise.