SUCCESS STORY ON DEVIATIONS & CAPA MANAGEMENT. Teamwork & Quality Expertise for Timely Corrections & Improved Compliance in Manufacturing

Transcription

1 SUCCESS STORY ON DEVIATIONS & CAPA MANAGEMENT Teamwork & Quality Expertise for Timely Corrections & Improved Compliance in Manufacturing

2 With the expertise of The Biotech Quality Group (BQG), a major Biopharmaceutical company reduced a large backlog of deviations to less than 5% by the FDA-mandated deadline in one of its filling facilities and decreased occurrence of additional deviations, incorporating compliant and efficient manufacturing procedures.

3 BACKGROUND The Food and Drug Administration (FDA) requires deviations to be investigated and completed within 30 days before being considered late. After assessing product impact, and investigating the root causes, the company establishes Corrective Actions/Preventive Actions (CAPA) to avoid recurrences of major and critical deviations. Nevertheless, operational disruption, lack of resources, deviation complexity and/or suboptimal application of CAPA can result in an accumulation of late deviations, creating a backlog to be quickly addressed in order to stay compliant with regulations. PROBLEM To correct a backlog of deviations before a key regulatory deadline and decrease the future number of deviations. After an FDA inspection at a major pharmaceutical company, the company s representatives committed, on a global scale, to reduce to less than 5% the proportion of late deviations (i.e., greater than 30 days old). This commitment impacted one of its biological product filling facilities where a backlog of deviations had to be corrected by March Also, the numerous deviations increased internal costs (of investigation, storage, and machine stops) and prevented product release, thereby decreasing available stock of product, jeopardizing the supply chain, and thus potential revenues. To reduce the number of deviations in a timely manner and acquire external knowledge, the pharmaceutical company started a partnership with The Biotech Quality Group. BQG S SOLUTION Use best practices in analysis, project management, and teamwork to investigate causes of deviations, design CAPA, implement CAPA faster, and improve product impact. 3

4 1 First Phase Project Fixed Price V1 : Reduction of a defined number of late deviations. After a focused diagnostic to assess the backlog of deviations, BQG decided to support the client with a fixed price proposal, with commitment to achieve the deliverables. The initial scope of the project V1 was : month project Correction of 249 deviations Deployment of 250 CAPAs BQG conducted a kick-off meeting with the clients to scope out the project and agree on objectives, project planning, timing, reporting, and key deliverables. The goal was to stabilize, clean, and decrease the current deviation and CAPA backlog in 6 months (May to October 2013), by resolving 12 deviations per week and deploying 30 CAPAs per month, while still respecting local procedures, impact assessment, good investigation practices, and risk management. For a first quick response, the project V1 involved a small team, consisting of 5 senior BQG experts. After having followed a training on the client process and local procedures, the team took office in the client s facility. Highest priority was given to deviations affecting critical equipment in the filling line and/or preventing the release of batches. Similar deviations were grouped together for higher efficiency. 4

5 Efficient treatment of deviations required the following project management, investigation, and teamwork tools that BQG deployed while still adhering to local procedures : Daily meetings with supervisors on investigation, situational analysis of problems, and defining priorities. Check in/check out lists of deviations to be handled and corrected within each week. Steering committee (Steerco) with the management to give an overview of the project progress and highlight blocking points. Locate all key team members closest to the floor. The Client was extremely satisfied with the results and speed at which project V1 was addressed. The project lasted only 5.5 months, instead of the 6 months originally planned. BQG was invited to stay and build another team to follow up on other deviation backlogs. 5

6 2 Second Phase Project Reduction of Backlog and Continuous Quality Improvement. Because of insufficient workforce, the pharmaceutical company did not implement certain CAPA created during V1, resulting in recurrence of some deviations. Although V1 was successfully completed, 130 additional deviations in the filling facility had accumulated. The challenging objectives of the second phase were to absorb the backlog and to implement CAPAs in parallel, in order to reduce deviation accumulation and correct the entire backlog by March The identification of internal communication issues between Quality Assurance and Production that had hampered the client from correcting past deviations within 30 days had to be tackled. To improve communication and maintain a high rate of deviation closure, BQG, who represented the client s Production team, collaborated with the client s Quality Assurance team to establish a charter about standard content required for a deviation and best practices of managing deviations. The BQG team designed CAPAs based on identified root causes, while the client managed the implementation and check of effectiveness of CAPAs. The success of project V1 and the gain of the client s trust led to a long-term partnership, initiated in October BQG s staffing involved successive teams, consisting of up to 9 operational and intermediate advisors (some from partner consultancy firms). A new organization was set up, operational advisors were placed in individual departments (calibration and measurement, logistics, environmental monitoring, filling/capping, and lyophilization), thereby enhancing project efficiency and leveraging the advisors expertise. TRAINING HANDLING 1 st DEVIATION HANDLING 2 ADDITIONAL DEVIATIONS HANDLING 3 ADDITIONAL DEVIATIONS CORRECTION OF THE 1 st DEVIATION HANDLING 2 ADDITIONAL DEVIATIONS CORRECTION OF 2 DEVIATIONS HANDLING 3 ADDITIONAL CORRECTION DEVIATIONS OF 3 CORRECTION DEVIATIONS OF 3 DEVIATIONS Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Figure 1: BQG Advisor Organization Chart 6

7 In June 2014, BQG increased its staffing of operational advisors to work on deviations and helped create new CAPAs, thereby facilitating the implementation of new CAPAs in order to reduce recurrence of deviations. This long-term partnership phase had evolved over time from backlog management to day-to-day deviation management in order to avoid a new backlog and ensure continuous quality improvement. Treatment of deviations during V2, which evolved during the long-term project, involved the following supplementary project management and teamwork tools based on V1 experience: Short meetings on deviations, causes, and implementing CAPAs with facility head. Committee for approval of implementation of CAPA. CARDEX, a visual information tool for time and deviations management (daily activities and personal roles) and implementation of CAPA by departments. CARDEX LATE +30j REEX* Initiation > Prod/QA 1 st Review > QA Investigation complete > Prod Final complete > QA Days * Request for an extension of the closure deadline (30 days) which is approved by the QA. The deviation is not Figure considered as late 2 if it : does Deviations not exceed the additional timemanagement Table CARDEX 7

8 3 Results Dramatic and timely correction of accumulated deviations and decrease of additional deviations. Project V1 was a definite and rapid success in terms of investigation of deviations, design of CAPA, achieving the objective within the timeframe, and gaining customer satisfaction with results. Deviation and CAPA backlog decreased to zero two weeks earlier than planned. In less than 5,5 months, 243 late deviations were corrected, and 491 tasks CAPAs were implemented. During project V2, 3 deviations per week per expert were completed successfully. By March 2015, the goal of reducing the backlog in the filling facility to no more than 5% was accomplished. Release GIO 2% Prod/mat/sample Testing GIO 3% 2% Validation/Requalification GIO 9% Documentation and Electronic Record Process 36 % 42 % Environmental Monitoring 6% Others Figure 3 : Deviation Distribution (2015) 8

9 The second phase project, which is still ongoing, has evolved into continuous quality improvement to manage current deviations and prevent future deviations. The outstanding accomplishments in the client s quality compliance are : Higher efficiency of CAPAs. Higher quality of documentations about deviations. Increase in knowledge by in-house quality teams. Spreading best practices tools and methodologies to other departments. ENHANCEMENT OF INVESTIGATION DEGREE HIGHTER LEVEL OF QUALITY BETTER IDENTIFICATION OF ROOT CAUSE SUPERIOR REL OF CAPAS Figure 4 : Continuous improvement 9

10 The pharmaceutical company was impressed by the results of the first and the second phase of the project. They characterized consulting by BQG as «resultsoriented, always able to predict, skilled in creating and implementing solutions, and undeterred by the large pharmaceutical environment.» 4 Impact of Quality Knowledge & Management The pharmaceutical company has embraced continuous quality improvement, and some advisors were assigned to other departments and/or facilities, thereby extending enhanced compliance and more efficient practices to other manufacturing departments and facilities. BQG s case study in deviations reduction demonstrates : Expertise in emergency management of deviations. Implementation of best practices tools, allowing good, sustainable management of deviations. Efficiency in training the client teams on BQG methodologies and tools. Importance of excellence in project management and organization. Teamwork and communication as actionable philosophies. 10

11 Consulting partnership with BQG helps biopharmaceutical companies achieve superior quality compliance to regulatory requirements in a timely and cost-effective manner. 11