Steriles Business Case : Recovery from a bad inspection
When an FDA inspection ends in multiple observations, it's bad news. So it was for the European Manufacturing subsidiary of a major multinational.
The site manufactured several key sterile products, mainly vials with the major product being a beta-lactamine*, and the FDA required a team of observers to report on sterile suite behaviour and practise; in order to implement the range of the corrective improvements needed. Observations included poor operator behaviour, incorrect gowning, compromise of the class A filling area, poor maintenance interventions and poor monitoring systems.
Knowing Galenisys expertise in sterility assurance and aseptic processing, the multinational Head Office turned to Galenisys to undertake the on-site work, with an experienced team of sufficient strength; in cooperation with local management and coordinated by the Boston Consulting Group and the Galenisys on-site project manager.
After conclusion of the Confidentiality Agreement and agreed Terms of Reference, Galenisys deployed our team of specialists to site. It was headed up by one of our most experienced experts.
Working in teams to observe the 24/7 operation, over a period of months, Galenisys drove the improvements in operator behaviour, and modifications to the procedures and testing practises which were required. Galenisys spent considerable time coaching key individuals in aseptic technique and relevant regulatory requirements. Separate training for the operations and maintenance teams was undertaken. After each observation session, the Production, Maintenance and Quality teams met in an adjacent meeting room where the days observations were presented, and everyone took time to discuss and agree how improvements could be introduced.
Each week, findings and Corrective Actions were discussed with local and central management.
Galenisys included the Corrective and Preventive Actions (“CAPAs”), in the training they gave on appropriate behaviour & revised procedures including aseptic activity monitoring, process validation – sterilisation APS, disinfection and cleaning techniques (a major headache) - data evaluation and use, sterility assurance programmes and contamination prevention and control.
The final phase of the terms of reference was to verify that the required training and updated procedures were resulting in the improvements required, and product conformity.
It’s pleasing to note that the same company has now used Galenisys teams on more than 10 of their sites worldwide to improve aseptic techniques.
Case Study : Root Cause Investigation & Remediation of Sterile Product Contamination
A leading manufacturer of sterile injectable products recently encountered an unexpected microbiological issue affecting one of its well-known pharmaceutical gels based on hyaluronidase. Upon detection of this deviation by their internal Quality Assurance team, the manufacturer promptly engaged Galenisys to investigate the root cause and propose corrective and preventive actions.
Following the signature of a mutual non-disclosure agreement, Galenisys submitted a proposal for an on-site assessment by two senior industrial microbiologists, each with extensive expertise in the manufacture and quality control of sterile medicinal products. The scope of this intervention covered all contamination prevention systems and procedures, including those related to raw materials, equipment, personnel, and environmental controls.
Once our proposal was rapidly approved, the Galenisys experts worked in close collaboration with the site team to conduct a comprehensive assessment. The contaminant had already been correctly identified by the client's QA function as a species of Pseudomonadaceae, which allowed our investigation to focus on potential sources and vectors throughout the facility, including utilities, equipment design, manufacturing steps, cleaning practices, and validation protocols.
Thanks to the transparency and professionalism of the site team, Galenisys was able to pinpoint key contributing factors, notably issues related to equipment design and inadequate cleaning and sanitization procedures. Our experts provided detailed written recommendations, including practical explanations to help operational and QA staff understand the specific conditions under which Ps.spp. can thrive.
Additional recommendations were made concerning the maintenance and management of the purified water system, with a focus on minimizing the risk of microbial proliferation.
Following our intervention, we were pleased to receive confirmation from the manufacturer that the proposed corrective measures had been implemented, and that the issue of contamination had been fully resolved.
This case study highlights the effectiveness of two key formal documents within the Galenisys Quality Assurance framework, which are available to all clients:
- Galenisys Contamination Prevention & Control – Key Elements
- Galenisys Contamination Prevention & Control – Programme