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Deviation Management Support for New Plasma Fractionation Facility

A pharmaceutical company operating a newly built plasma fractionation facility approached Zamann Pharma Support due to an increasing backlog of deviations. The facility had implemented stringent specifications for media, environmental monitoring, and manufacturing processes—especially for plasma fractions—which led to a high number of complex deviations. The client sought expert support to manage the volume, improve investigation quality, and ensure regulatory readiness.

Challenges Faced

A detailed GAP analysis in Quality Management Systems is essential for identifying process deficiencies effectively.
  • High Deviation Backlog: The new facility had accumulated a substantial number of open deviations, straining internal QA and manufacturing teams. 
  • Stringent Specifications: Due to heightened quality standards—especially for the manufacturing process as well as for environmental and media monitoring—minor process variances frequently triggered deviations. 
  • Cross-Functional Complexity: Deviations spanned multiple departments (manufacturing, QC, monitoring), requiring coordinated root cause investigations and CAPA planning. 
  • Regulatory Pressure: As a newly operational GMP facility, the company anticipated inspections from national and international authorities such as FDA and needed to demonstrate robust deviation handling. 

Zamann Pharma Support’s Approach

Initial Assessment & Strategy Setup: 

  • Conducted stakeholder interviews and reviewed deviation KPIs, SOPs, and current workflows. 
  • Prioritized the backlog based on risk classification and business impact (e.g., product impact, regulatory risk, recurrence). 
  • Established a deviation triage and fast-track process to segregate critical vs. minor cases. 

 

On-Site Support & Process Integration: 

  • Deployed experienced deviation management consultants to support backlog processing on-site. 
  • Introduced clear workflows and escalation paths for complex deviations, reducing bottlenecks in review and approval. 
  • Established cross-functional deviation review boards to accelerate closure timelines and improve CAPA quality. 

 

Quality System Alignment: 

  • Aligned deviation documentation with internal QMS, SOPs and QA. 
  • Structured root cause analysis (RCA) model with standard templates (e.g., 5-Why, Fishbone) to ensure consistent investigations. 
  • Recommended updates to deviation categorization and escalation rules in alignment with QA. 

 

Training & Sustainability: 

  • Targeted training with Non Conformity Owner, QA, Manufacturing, and QC teams on deviation lifecycle, risk categorization, and inspection-readiness. 
  • Delivered a deviation management playbook with key examples, best practices, and checklists for Project dedicated NCO’s. 

Results Achieved

  • Backlog Reduction: Over 70% of the deviation backlog was successfully processed within 3 months, meeting internal KPIs. 
  • Improved Deviation Quality: Enhanced documentation, impact assessments, and CAPA planning resulted in a measurable improvement in audit readiness and reduced reocurrence rates. 
  • Audit Readiness: The client passed a pre-inspection readiness audit with no critical findings in deviation handling. 
  • Cross-Team Collaboration: The deviation review boards improved cooperation between QA, Manufacturing, and QC, creating shared accountability. 
  • Sustainable Improvement: Internal teams were equipped with tools and training to independently manage future deviations more efficiently. 
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Pharmaceutical team managing GMP Quality Management System (QMS) activities, reviewing change control records, CAPA documentation, deviation reports, and audit readiness data in a regulated manufacturing environment.
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Quality Management System

We work with pharmaceutical teams to design, implement, and run effective Quality Management Systems, covering change control, CAPA, deviations, and audits to support consistent GMP compliance.

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FAQ

1. How can a new plasma fractionation facility reduce a large backlog of quality deviations without affecting production flow?

Facilities first apply risk-based prioritization to classify deviations by product impact and regulatory risk. Then, they assign dedicated teams to process critical cases using fast-track workflows. As a result, companies reduce backlog quickly while keeping production and quality operations stable.

2. What is the most effective way to improve root cause analysis for complex deviations in sterile and biological manufacturing environments?

Organizations standardize root cause analysis by using structured tools like 5-Why and Fishbone diagrams. In addition, cross-functional teams from QA, QC, and manufacturing review each deviation together. Therefore, investigation quality improves and recurrence rates decrease significantly.

3. How do deviation management systems support inspection readiness in GMP-regulated facilities?

Strong deviation systems ensure complete documentation, clear impact assessment, and well-defined CAPA actions. Moreover, regular deviation review boards improve transparency across departments. Consequently, inspectors see consistent control, and facilities achieve higher compliance confidence during audits.