Pharma Manufacturing Building Commissioning

A pharmaceutical company near Frankfurt in Germany, was commissioning a new pharmaceutical manufacturing building but faced significant challenges in getting the facility fully operational. Multiple runs were required—water runs, engineering runs, validation runs, and Process Performance Qualification (PPQ) runs. Each activity involved multiple departments and distinct procedures that had to be synchronized. The organization needed a structured plan that would accommodate everything from tech transfer and method validation to stability testing and process validation.

Zamann Pharma Support was engaged to provide guidance and coordination. We improved and took over an already introduced central “Master Sample List” where all departments could specify their sample requirements and testing needs during the commissioning runs. This enabled effective planning for every stage of the runs while helping maintain compliance. We also implemented “Run Guides” for each major activity, capturing the scope, responsibilities, timelines, and contact details for everyone involved. By addressing stakeholder involvement, data collection, and compliance considerations, the site was able to move forward in a controlled, well-documented manner.

Challenges Faced

Multiple Stakeholders and Departments: Engineering, quality assurance, tech transfer teams, and method validation experts all needed input into the runs. Without proper coordination, overlapping responsibilities risked confusion, delays, and gaps in documentation.
Complex Scheduling: Water runs, engineering runs, validation runs, and PPQ runs each had different objectives and success criteria. Timelines needed alignment to ensure samples were taken correctly and systems were tested in the right sequence.
Data Management and Oversight: Numerous data sets were generated by each activity, and these had to be gathered and stored consistently for compliance. Gaps or discrepancies could lead to overlooked critical parameters.
Regulatory Compliance: With a new facility, the organization needed to demonstrate that every stage met appropriate regulatory standards. Any step performed incorrectly could attract scrutiny from health authorities and delay product release.

Zamann Pharma Support’s Approach

Central Master Sample List: We created a single reference point for all sample requirements, bringing clarity to each department’s requests. This list specified the type of samples needed, the purpose of the analysis, and the relevant project phase (e.g., stability, device verification, method validation).
“Run Guide” for Every Activity: Before each run, a structured plan was drafted to outline the scope, objectives, and team contacts. This included every activity planned, from sampling points to test methods and equipment usage. The guides served as reference documents, ensuring that everyone knew their roles and what was expected.
Cross-Department Coordination: Weekly meetings and real-time communication channels helped synchronize tasks. Engineering teams worked with QA and lab analysts to confirm that the runs were executed in a logical order, preventing bottlenecks.
Data Collection and Summaries: Our team oversaw the capture of results from water runs, validation runs, and PPQ activities. We compiled these into clear overviews, organizing analytics and lessons learned for each phase. This central repository minimized duplication of efforts and ensured that all findings were easy to retrieve.
Maintaining Compliance: At each step, we ensured alignment with regulatory requirements. Proper documentation practices, batch records, and protocols were enforced. The systematic approach helped demonstrate to auditors and other stakeholders that the building and processes met required quality standards.

Results Achieved

Efficient Commissioning Process: By systematically coordinating the runs, the building was brought online more quickly than anticipated. The central sample list and Run Guides eliminated guesswork and minimized repeated work.
Clear Documentation: The “Run Guides” and compiled analytics provided a transparent overview of all activities. As a result, the site had an organized record of each run’s objectives, outcomes, and participants.
Improved Cross-Functional Collaboration: Departments collaborated more effectively, as responsibilities and timelines were fully mapped. This fostered a collaborative environment, improving communication across engineering, quality, and production teams.
Enhanced Regulatory Readiness: Detailed planning and data capture demonstrated that each run was performed in accordance with regulations. The site had well-structured records to present to inspectors, reducing the risk of compliance issues.

Services

Qualification and Validation for GMP Systems

Our team supports the planning, execution, and maintenance of qualification and validation activities, including IQ, OQ, and PQ, to keep GMP-regulated systems compliant and under control.

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FAQ

1. How can multiple commissioning runs (water, engineering, validation, PPQ) be effectively synchronized in a newly built manufacturing facility?

Effective synchronization requires a unified master planning layer that aligns objectives, sampling points, and acceptance criteria across all run types. Using a structured “run sequencing model” ensures that outputs from engineering runs directly inform validation activities, while PPQ execution is only initiated after predefined readiness gates are met. This prevents misaligned execution and reduces rework caused by premature testing or incomplete system readiness.

2. What is the role of a centralized sample management system during facility commissioning and validation activities?

A centralized sample management system acts as a single source of truth for all sampling requirements across departments. It defines sample type, analytical purpose, and associated lifecycle stage (e.g., method validation, stability, process validation). This prevents duplicate sampling, eliminates conflicting requests between QA, QC, and engineering teams, and ensures traceability of all analytical inputs used for regulatory documentation.

3. How do structured run documents improve regulatory inspection readiness during facility start-up?

Structured run documents (such as run guides) provide inspectors with a complete audit trail of execution logic, responsibilities, and deviation handling for each commissioning phase. They ensure that every operational step sampling, equipment use, and testing can be traced back to predefined protocols. This significantly strengthens data integrity assurance and reduces findings related to incomplete documentation or unclear execution ownership during regulatory inspections

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