“The expert in asepsis and sterility assurance“

Troubleshooting Quality Issues

Troubleshooting Quality Issues

Technology is advancing rapidly and its application in the production of pharmaceuticals is changing all the time.
At Galenisys, our consultants keep up to date with the latest technological advancements in the pharmaceutical industry – from computer and IT systems to new engineering and processing techniques.

If you need to resolve technical issues at your facility, Galenisys can provide up-to-date knowledge and engineering expertise in the following technical areas:

Technical systems and infrastructure

  • Water and utility systems
  • Equipment and facilities
  • Documentation systems
  • Data management and storage
  • Quality control laboratories and analytical methods

Product contamination

  • Sterility assurance
  • Bio-containment
  • Product contamination – viable and non-viable
  • Product inspection

Resolving investigations and regulatory issues

  • Management of Out Of Specification (OOS) results
  • Non-conformity and related investigations
  • Closure of issues with regulatory authorities
  • Reconciliation of regulatory dossiers and actual practices

If you don’t have known quality issues at your facility but would like to keep up with the latest technology where possible, simply ask us to perform a full audit of your systems.

We will provide a formal report, as well as a follow-up service to design and implement new technologies in your production chain. Learn more about audits.

Galenisys 11, rue Notre Dame de
Nazareth 75003 Paris – France
+33 (0)1 45554414

Galenisys USA Inc. 4359, Ravinewood
Dr. Commerce Mi 48382 USA
(248) 676 0521