Segregation of QMS system requirements for different business entities

A global pharmaceutical company approached Zamann Pharma Support to provide expert guidance in segregating their Quality Management System (QMS) requirements to accommodate multiple business entities. These entities, spanning manufacturing, distribution, warehousing, and laboratory services, operated under differing regulatory and operational demands. Zamann Pharma Support proposed a tailored and systematic approach to align QMS processes with entity-specific needs while ensuring overall compliance with global and local regulatory requirements.

Challenges Faced

Entity-Specific Requirements: Different business entities required QMS customization to address unique operational and compliance needs (e.g., GMP for manufacturing, GDP for distribution).
Complex Regulatory Landscape: The project had to comply with global standards (ISO 9001, EU GMP/GDP, ICH guidelines) while also considering regional regulatory expectations.
Interdependencies: Ensuring process consistency across interconnected entities without redundancy or non-compliance.
Time Constraints: The implementation had to be completed within a short timeframe to align with upcoming audits and regulatory inspections.

Zamann Pharma Support’s Approach

Project Initialization: Conducted a kick-off meeting with key stakeholders from all business entities to define goals, scope, and timelines. We performed a detailed assessment of the existing QMS framework to identify overlaps, gaps, and entity-specific requirements.
System Segmentation Analysis:
1. Segregated QMS processes into core and entity-specific requirements (e.g., Change Control, CAPA, and Document Management).
2. Identified processes that required tailoring to address specific business operations, such as warehousing vs. packaging environments.
3. Conducted workshops with entity representatives to validate their operational requirements and regulatory responsibilities.
Custom QMS Design:
1. Developed modular templates for critical QMS processes to ensure flexibility and scalability across entities.
2. Integrated risk-based approaches to ensure alignment with EU GMP/GDP and ISO standards, prioritizing high-risk activities for stricter controls.
3. Streamlined documentation workflows to minimize redundancy and ensure clarity across all entities.
Implementation Support:
1. Delivered tailored SOPs, manuals, and training materials for each business entity.
2. Conducted workshops to train internal teams on implementing entity-specific QMS requirements.
3. Established a monitoring system to ensure compliance and process consistency across all entities.

Results Achieved

Customized Compliance: Each business entity received a tailored QMS that addressed its unique operational needs while maintaining global and local regulatory compliance.
Improved Efficiency: Streamlined and segmented QMS processes reduced redundancies and increased clarity, making system management more efficient.
Risk Mitigation: A risk-based approach ensured that high-risk areas were prioritized, reducing the likelihood of regulatory findings during audits and inspections.
Team Empowerment: Through workshops and hands-on training, the client’s teams gained a thorough understanding of the new QMS structure and its execution.
On-Time Delivery: The project was successfully completed within the defined timeline, allowing the client to prepare for upcoming inspections without delays.

Client Testimonial

“ Zamann Pharma Support played a crucial role in helping us tailor our QMS processes for our diverse business operations. Their expertise ensured compliance with global and regional requirements while streamlining workflows across all entities. The project was delivered on time, and their practical training empowered our teams to maintain the new system effectively. Zamann’s support exceeded our expectations, and we highly recommend them for QMS-related projects.”

Contact Us

Need help? Don't hesitate to get in touch

First Name*

Last Name*

Email*

Phone number*

Role*

Department*

Country

Industry

Message

Zamann pharma support is committed to protecting and respecting your privacy, and we’ll use your personal information to administer your account and to provide the products and services you requested from us.

Yes, I agree to receive personalized newsletters with market insights, invitations for exclusive events and educational webinars from the Zamann Pharma Support GmbH.

I consent to the privacy policy and understand that my personal data will be stored and processed*

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com