project

Operational quality, remediation, diagnostic for a pharmaceutical production site

Compliance Life Sciences France

Context and challenges

The customer, a drug manufacturer, is a subcontractor for major pharmaceutical companies. One of its production sites in western France is specialised in the production of sterile injectable products and drinkable solutions. It is responsible for the preparation, filling, manual inspection, and primary and secondary packaging.

The customer's teams observed an increasing number of quality deviations that were not resolved in time, in particular in the sterile filling activity. This resulted in delays that led to a bottleneck in the supply chain, which had a direct impact on the availability of pharmaceutical batches on the market. These delays were also creating tension in the in-house teams.

The customer asked Assystem Care to manage the backlog of deviations (process the deviations and identify ways to improve this process), and to provide assistance for the customer's "operational quality" activities.

Project scope

  • Set up of an Atlas* ‘Task Force’:
    • Introduction of a team of 6 consultants to manage the backlog of deviations and the operational quality activities: management of complaints, review of batch records, management of PQR(1)
    • Definition of project organisation: management roles, deliverables, scheduling, reporting and piloting tools
    • Definition of key performance indicators: 5 quality deviations processed and 4 batch files reviewed each week by each member
    • Piloting of quality deviations and situational analysis (number of deviations by sector, backlogs, disputes, etc.)
  • Apollo diagnostic focus*:
    • Assessment of strengths and weakness of the process for managing deviations
    • Review of documents/data, organisation of meetings with key personnel in the process and GEMBA(2) in the production zone and the Quality offices
    • Organisation of two workshops to list the gaps and blocking points in the process, and to find solutions and suggestions for improvement
    • Reporting of all observations and recommendations as part of a steering committee, with sponsors identified for the project and creation of a roadmap
    • Implementation of Quick Win solutions: description and distribution of a process to release the batches in the supply department; introduction of weekly meetings; review of management tables; streamlining and simplification of files for monitoring deviations; review of templates; definition of standards for automatic generation of reports for complaints and recurring deviations; creation of a standard checklist to review batch files
  • Delivery of a SWOT(3) report on the process for managing deviations, and interface with product release
  • Delivery of a roadmap for specific areas: strategy, process, and people/organisation
*Apollo Maturity and Atlas are exclusive Assystem Care solutions that include all project management tools and make use of standardised processes and methodologies.

(1) PQR : Product Quality Review
(2) GEMBA : "shop floor visits" as part of the lean approach
(3) SWOT : Strenghts Weaknesses Opportunities and Threats

Results

  • 400 deviations identified in the first week on site, compared with the 60 deviations reported by the customer
  • Processing of more than 230 deviations, 100 batch files, 65 complaints and 25 PQR(1)
  • Improved readiness levels and efficiency for the customer, with confidence building following the transfer of know-how and best practices for managing deviations
  • Time saving through the use of automated complaint reports with standardised replies
  • Time saving and better product traceability through the use of a checklist to review the pharmaceutical batch files (to make sure all the documents and products are present for the batch file review and the release phase)

In figures

00

people interviewed

0

GEMBA sessions

0

workshops about continuous improvement

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