Qualified packaging systems from IWK guarantee the highest quality, traceability and regulatory certainty – from development to operation.
Contact usIn the pharmaceutical industry, compliance determines the approval and economic success of a product.
Validation processes must be documented, traceable and repeatable – over the entire system life cycle. Lack of documentation or unvalidated processes jeopardize product safety, auditability, and production release. IWK supports pharmaceutical companies in reliably meeting these regulatory requirements.
IWK offers a comprehensive qualification package that supports all regulatory requirements from planning to production release.
Our approach includes:
The qualification package is based on the guidelines of GAMP 5, EU Annex 15 and FDA 21 CFR Part 11. In addition, experienced IWK experts accompany the equipment throughout its entire life cycle.
The qualification process at IWK follows a clearly defined quality management system. Each phase is documented, traceable, and embedded in the overall framework of project documentation.
Scope of services:
All IWK systems are designed, manufactured and documented in accordance with internationally recognised standards. The qualification package includes full GMP documentation, DQ/IQ/OQ protocols.
Supported Standards:
Standards Met:
Customers benefit from auditable documents.
IWK supports according to GAMP 5, EU Annex 15, ISO 9001 and FDA 21 CFR Part 1.
Yes, IWK provides complete DQ/IQ/OQ documentation as well as risk analyses and change logs.
Yes, IWK offers requalifications for existing machines. In addition, completely new qualifications can be carried out for control system conversions. For small changes, IWK offers Change Protocol Documents.
No, the responsibility lies with the plant operator. IWK is available to support you in a spirit of partnership.
