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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Equipment Qualification – Routine Support

Zamann Pharma Support GmbH offers comprehensive support for equipment qualification in pharmaceutical manufacturing facilities. Our services ensure that equipment used in production processes meets regulatory requirements and industry standards, contributing to product quality, safety, and compliance

scientist monitors the readings on the equipment

User Requirement Specification (URS) and Equipment Selection

We support on URS to identify critical equipment and potential risks to product quality and patient safety. Our experts assist in selecting appropriate equipment based on intended use, process requirements, and regulatory expectations, ensuring suitability for intended applications.

Installation and Operational Qualification (IQ/OQ)

Our team provides support for the installation and operational qualification of equipment, including the development and execution of IQ and OQ protocols. We verify proper installation, functionality, and performance of equipment to ensure it operates within specified parameters and meets predefined acceptance criteria.

Performance Qualification (PQ) and Continued Monitoring

We conduct performance qualification studies to assess the ability of equipment to consistently produce product meeting quality attributes. Additionally, we establish monitoring programs to ensure ongoing compliance with qualification status and regulatory expectations, including periodic requalification and performance monitoring.

A person in a cleanroom suit working on machinery in a technology manufacturing facility.

Equipment Qualification –
Execution

Senior man, research scientist writes notes, lab observations. Male researcher carrying out

Equipment Qualification – Project Management

Water Quality Officer assesses RO systems, ensuring standards, safety and control the contamination

Equipment Qualification – Workshop and Trainings

Customized support for Qualification and Validation

We provide Qualification and Validation support, designed specifically to your facility and products, ensuring that each process is meticulously designed, documented, and verified. With our hands-on support, you can trust that your operations meet all regulatory standards

Why Zamann?

Zamann’s expertise in Qualification and Validation is rooted in industry best practices and rigorous global regulatory insight. Our team brings a thorough approach that secures compliance, improves reliability, and supports your facility’s operational success

Modern Laboratory Work Space

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