Zwick India's DQ/IQ/OQ Qualification Service

According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”

This means a quantitative approach is needed to prove quality, functionality, and performance of a pharmaceutical/biotechnological manufacturing process. This approach will be applied to individual pieces of equipment as well as the manufacturing process as a whole. Guidelines for validation are set by the FDA, but the specifications of validation are determined by the pharmaceutical/biotech company.

User Requirements Specification (URS) is the most critical of documents whether the system is purely mechanical, or a mix of electro-mechanical, or solely a software program, the successful compilation and execution of the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), is dependent on a User Requirements Specification (URS) containing clear, concise and testable requirements.

For the DQ, IQ and OQ stages in the qualification of materials testing systems, Zwick Roell assists you by providing comprehensive, individually tailored qualification documentation in accordance with GAMP5 (Good Automated Manufacturing Practice) and current guidelines, as well as providing support during the actual on-site qualification procedure by a well-trained expert in the Indian subcontinent.

For any enquiries, we are happy to address them at info@zwick.co.in


Zwick Roell Testing Machines Pvt. Ltd
Tel.  +91 44 43090450
E-Mail  info@zwick.co.in


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